Research and Clinical Trials

JOIN A CLINICAL TRIAL

JOIN A RESEARCH STUDY

 

For more information, please contact Clinical Research Coordinator Jennifer Garrett, RN, at 281.222.9983 or email jmgarrett@houstonmethodist.org



 

 

Aducanumab in Early Alzheimer’s Disease

The purpose of this Phase 3 study is to assess the efficacy and safety of aducanumab compared with placebo in subjects with early Alzheimer’s disease (AD), including subjects with mild cognitive impairment (MCI) due to AD and a subset of mild AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Biogen
  • Recruiting?: Yes
  • Official study title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease.
  • ClinicalTrials.gov identifierNCT02477800
  • Conditions studied: Alzheimer’s Disease (AD)
  • Intervention Drugs: Aducanumab (BIIB037)
  • Study Type: Interventional Study
  • Study Phase: 3
  • Duration of participation: The expected time the subject will be in the study is around 2 years. If the subject is eligible for ‘Long Term Extension (LTE)” part of this study and wish to participate in LTE part, he/she can participate for additional 2 ½ years.
  •  IRB #: Pro00017034
  • IRB approval date: 9/5/2017

Eligibility
Inclusion criteria: 
Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:

  • Age: 50 Years to 85 Years
  • A Clinical Dementia Rating (CDR)-Global Score of 0.5
  • Objective evidence of cognitive impairment at screening
  • An MMSE score between 24 and 30 (inclusive)
  • Must have a positive amyloid Positron Emission Tomography (PET) scan
  • Must consent to apolipoprotein E (ApoE) genotyping
  • If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
  • Must have a reliable informant or caregiver

Exclusion criteria: 
All participants must not meet the following criteria:

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Clinically significant unstable psychiatric illness in past 6 months
  • History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
  • Indication of impaired renal or liver function
  • Have human immunodeficiency virus (HIV) infection
  • Have a significant systematic illness or infection in past 30 days
  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
  • Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
  • Alcohol or substance abuse in past 1 year
  • Taking blood thinners (except for aspirin at a prophylactic dose or less)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

What is involved?
  • Testing and Procedures: History, Clinical and Neurological Examination, Memory and Thinking Skills tests, Psychological testing, Brain MRIs, PET scans, lumbar punctures (optional), ECGs, blood specimen collection (for biomarker and genetic testing), urine tests, and vital signs.
  • Frequency of visits: There are about 32 planned clinic visits during the placebo controlled part of the study and up to 8 telephone safety follow-up contacts, as follows:
    • Screening Visits no more than 60 days before the first dose of study treatment on Day 1 (visits will be conducted on multiple days)
    • 20 outpatient dosing visits (one every 4 weeks when treatment will be administered)
    • 8 telephone safety follow-up contacts approximately 2 weeks after each of the first 8 doses
    • 3 visits for clinical assessments
    • 2 visits for CSF biomarkers (optional)
    • 3 visits for amyloid PET scan (in a subset of subjects)
    • 2 visits for Tau PET scan (in a subset of subjects)
    • 7 visits for brain MRI
    • 1 follow-up safety visit at Week 94 (only for subjects not entering the LTE) or 18 weeks after last administration of study treatment for those subjects who withdraw from study
  • If you enter the LTE part of the study, you will have approximately 36 additional visits, and up to 8 telephone safety follow-up contacts, as follows:
    • 26 outpatient dosing visits
    • 8 telephone safety follow-up contacts approximately 2 weeks after each of the first 8 doses
    • 4 visits for clinical assessments
    • 2 visits for CSF biomarkers (optional)
    • 2 visits for amyloid PET scan (in a subset of subjects).
    • 2 visits for Tau PET scan (where available, in a subset of subjects)
    • 7 visits for brain MRI
    • 1 follow-up safety visit at week 198 (or 18 weeks after last administration of study treatment for those subjects who withdraw from study
  • The study doctor may ask you to attend for additional Unscheduled Visits for safety or before you start any new AD medication.
Costs: No costs will be charged for any of the study procedures. To compensate the time you take to undergo the procedures in this study, you will receive $50 per completed study-related visit. Your study partner will also receive $50 per completed study-related visit. You will receive a check in the mail form Houston Methodist

 

 

Top of page

 

 


 

 

An Efficacy and Safety Study of JNJ-54861911 in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia

The purpose of this study is to evaluate whether treatment with JNJ-54861911 slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are asymptomatic at risk for developing Alzheimer's dementia.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Janssen Research & Development, LLC.
  • Recruiting?: No
  • Official study title: A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy and Safety of JNJ-54861911 in Subjects Who Are Asymptomatic At Risk for Developing Alzheimer's Dementia.
  • ClinicalTrials.gov identifier:  NCT02569398
  • Conditions studied: Asymptomatic Amyloid-positive persons.
  • Intervention Drugs: JNJ-54861911
  • Study Type: Interventional Study
  • Study Phase: 2b/3
  • Duration of participation: The expected time the subject will be in the study is 5 years.
  •  IRB #: Pro00016561
  • IRB approval date: 9/7/2017
Eligibility
Inclusion criteria: 
  • Subjects must be between 60 years to 85 years (inclusive) of age.
  • Participant must have a global Clinical Dementia Rating Scale- (CDR) score of '0' at Screening.
  • Participants 60 to 64 years of age must also have 1 of the following 3 conditions: a) a positive family history for dementia (minimum of 1 first degree relative), b) a previously known apolipoprotein E, ε4 allele (APOE ɛ4) genotype, c) a previously known biomarker status demonstrating elevated amyloid accumulation in cerebrospinal fluid (CSF) or positron emission tomography (PET).
  • Participant must be able to read and write and must have adequate hearing and visual acuity to complete the psychometric tests. The legally acceptable representative must also be able to read and write.
  • Participants must have evidence of amyloid accumulation by means of either: a) low Cerebrospinal Fluid (CSF) ABeta 1-42 levels at Screening; b) a positive amyloid positron emission tomography (PET) scan at Screening (depending on the site's PET capability) by visual read.
  • Participant must be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or at Baseline.

Exclusion criteria: 
All participants must not meet the following criteria:

  • Participant is receiving an acetylcholinesterase (AChE) inhibitor and/or memantine at any time during Screening or Day 1 predose.
  • Participant has evidence of any brain diseases, other than potential very early signs of Alzheimer's Dementia (AD) or typical age-related changes or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that could explain a possible cognitive deficit.
  • Participant has any contraindications for MRI (example, prostheses, implants, claustrophobia, pacemaker).
  • Participant has met criteria for dementia or has a brain disorder that can cause dementia.
  • Participant has evidence of familial autosomal dominant AD.
What is involved?
  • Testing and Procedures: History, Clinical and Neurological Examination, Memory and Thinking Skills tests, Psychological testing, Brain MRIs, Amyloid PET scans, lumbar punctures, Skin exam, ECGs, blood specimen collection (for biomarker and genetic testing), and vital signs.
  • You will either receive JNJ-54861911 or placebo.  You will be put into one of three treatment groups described below.  This will be done by chance (like rolling dice). 
    There are 3 treatment groups in this study:
    • Group 1: 5 mg JNJ-54861911 taken as 1 tablet per day
    • Group 2: 25 mg JNJ-54861911 taken as 1 tablet per day
    • Group 3: placebo taken as 1 tablet per day
  • The chance that you will receive JNJ-54861911 is 2 out of every 3 participants. The chance that you will be assigned to placebo is 1 out of every 3 participants. 
  • Frequency of visits:
    • Screening period – multiple visits (expect 2 – 4 visits over 90 days period)
    • Treatment period – 28 visits
      • Follow-up period – 1 visit
  • Costs: No costs will be charged for any of the study procedures. You will receive $50 for each completed scheduled visit for your participation in the study.  These amounts will be paid to you approximately one month after completing each procedure.

 

 

 

Top of page

 

 


 

 

A Study of CAD106 and CNP520 versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at risk of developing clinical symptoms based on their age and genotype. The study will also observe and measure the biological response to the study treatment in participant’s body, and it will evaluate the safety and tolerability of CAD106 or CNP520. This study will assess the effects of each of the two therapies given separately, both targeting amyloid, on cognition, global clinical status, and underlying pathology in participants at risk for the onset of clinical symptoms of Alzheimer's disease (AD). Cognitively unimpaired individuals with two APOE4 are selected as they represent a population at particularly high risk of progression to Mild Cognitive Impairment and/or dementia due to Alzheimer's disease.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Novartis Pharmaceuticals
  • Recruiting?: Yes
  • Official study title: A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
  • ClinicalTrials.gov identifier:  NCT02565511
  • Conditions studied: Alzheimer’s Disease.
  • Intervention Drugs: Biological: CAD106 Immunotherapy (i.m. injections) vs. Placebo to CAD 106; and Drug: CNP 520 (p.o. capsule) vs. Placebo to CNP 520
  • Study Type: Interventional Study
  • Study Phase: 2/3
  • Duration of participation: The expected time the subject will be in the study is 5 - 8 years, depending on when you join the study. This is because participants who enroll in the study will continue until the last person that joins the study has been treated for 5 years; it is expected to take 3 years to enroll all participants
  •  IRB #: Pro00017853
  • IRB approval date: 12/8/2017
Eligibility
Inclusion criteria: 
  • Subjects must be between 60 years to 75 years (inclusive) of age.
  • Mini-Mental State Examination (MMSE) total score ≥ 24 and cognitively unimpaired as evaluated by memory tests performed at screening.
  • Homozygous APOE4 genotype.
  • Participant's willingness to have a study partner.

Exclusion criteria: 
All participants must not meet the following criteria:

  • Any disability that may prevent the participants from completing all study requirements.
  • Current medical or neurological condition that might impact cognition or performance on cognitive assessments.
  • Advanced, severe progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the participant at special risk.
  • History of malignancy of any organ system.
  • History of hypersensitivity to any of the investigational drugs or their excipients / adjuvant or to drugs of similar chemical classes.
  • Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).
  • Contraindication or intolerance to MRI or PET investigations (with fluorinated radio ligands).
  • Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to cognitive decline, might pose a risk to the participant, or might prevent a satisfactory MRI assessment for safety monitoring.
  • Suicidal Ideation or Suicidal Behavior in the past two years.
  • A positive drug screen at Screening, if, in the Investigator's opinion, this is due to drug abuse.
  • Significantly abnormal laboratory results at Screening, not as a result of a temporary condition.
  • Current clinically significant ECG findings.
  • Participants with depigmenting or hypopigmenting conditions (e.g. albinism vitiligo) or active / history of chronic urticarial in the past year.
What is involved?
  • Testing and Procedures: History, Clinical and Neurological Examination, Cognitive testing, Brain MRIs, Amyloid PET scans, Skin exam and photographs, ECGs, blood specimen collection (for antibody response, safety assessment, and genetic testing), urine drug testing, and vital signs.
  • This study is separated into two parts.
    • In Part 1 you will have genetic testing and you will learn your genetic test results (i.e. genotype).
    • Then, if your genotype is 4/4, you may be invited to participate in Part 2, the main study. During this Part 2, additional criteria on top of your genotype will also need to be verified. 
  • If you agree to join this study, and you are eligible for experimental treatment you will get assigned to either Group 1 OR Group 2. You will not be allowed to choose which group or treatment you receive.
  • If you are assigned to Group 1:
    • You will receive an intra-muscular injection (either CAD106 or a placebo) at the start of the study, at weeks 7 and 13 and then every quarter (every 13 weeks) for at least 5 years and no longer than 8 years.  The last injection will take place 6 months before you complete the study.
      CAD106 acts as a vaccine (a shot that protects a person from getting a disease) and it causes your body to produce a biological response. The body’s biological response to this vaccine may have beneficial effects in people who may be at risk for the onset of clinical symptoms of Alzheimer’s disease. So far, CAD106 has been given to a total of 206 patients with Alzheimer’s disease in four different studies conducted in Europe and in the USA. CAD106 has not been tested in people who are at risk for the onset of clinical symptoms of Alzheimer’s disease.
  • If you are assigned to Group 2:
  • You will receive an oral medication (either CNP520 or placebo) to take once a day for at least 5 years and no longer than 8 years. 
    CNP520 reduces the production of the amyloid protein in the brain.  It is being tested to see if it helps to delay the build-up of the plaques of amyloid (abnormal proteins).  So farCNP520 has been given to a total of 335 subjects.  CNP520 has not been tested in people who are at risk for the onset of clinical symptoms of Alzheimer’s disease.
    In your assigned Group, you will be given either study medicine (active ingredient) or a placebo (like a sugar solution or a sugar pill) with no active medicine inside. A placebo is used to make sure that the changes you experience are not happening just by chance. There is about an eight in thirteen chance (62% chance) of receiving one of the active study treatment drugs during the study.
  • Frequency of visits:
      • Screening phase  – multiple visits (expect 2 – 4 visits over 12 weeks period)
      • Treatment period – 23 – 26 visits over 5 years (may have 12 further visits over next 3 years if your study treatment is extended thus making a total of 35 – 38 visits over 8 years)
      • Follow-up period – 1 visit
  • Costs: No costs will be charged for any of the study procedures. You will receive $50 for each completed scheduled visit for your participation in the study.  These amounts will be paid to you approximately one month after completing each procedure.

 

 

 

Top of page



 

 

Alzheimer Prevention, A4, Study

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (the protein that forms plaques in the brains of people with Alzheimer’s disease) as compared with placebo in subjects with preclinical AD.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Eli Lilly & Company and National Institute on Aging (NIA)
  • Recruiting?: No
  • Official study title: Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4 Study)
  • ClinicalTrials.gov identifier: NCT02008357
  • Conditions studied: Risk for memory loss by amyloid brain deposition in older people
  • Intervention Drugs: Solanezumab and placebo control. Study drug (solanezumab or placebo) is administered as an intravenous infusion, every 4 weeks for 168 weeks.
  • Phase: Phase 3
  • Duration of participation: Up to 90 day screening period and 168 week treatment period
  • IRB #: Pro00013109
  • IRB approval date: 9/25/2015

Eligibility
Inclusion criteria: Subjects must be between 65–85 years of age (inclusive) and at screening have a Mini Mental State Examination (MMSE) score of 27–30 for subjects with high educational attainment (13 or more years of education) or 25–30 for subjects with low educational attainment (12 or fewer years of education). Subjects must have a Florbetapir PET scan at screening that shows evidence of brain amyloid pathology. Subjects must be on a stable dose of permitted medications for 6 weeks prior to the first infusion. Subjects must have a study partner who is willing to participate as a source of information and has at least weekly contact with the subject.
Exclusion criteria: Subjects must not be receiving acetylcholinesterase inhibitors (AChEI) and/or memantine at screening. Subjects must not lack good venous access. Subjects must not have any current serious or unstable illness including cardiovascular, hepatic, renal, respiratory, neurologic, psychiatric, or other conditions that could interfere with the study. Subjects must not have a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in loss of consciousness. Nor have history within the past 5 years of chronic alcohol or drug abuse or history within the past 2 years of major depression or bipolar disorder. Subjects must not have a history of schizophrenia or be at a serious risk for suicide.

What is involved?

  • Testing: Brain MRIs, Florbetapir PET scans, lumbar punctures (optional), neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood, and urine specimen collection, vital signs
  • Frequency of visits:
      • Up to 90-day screening period
      • Visits once every 4 weeks for 168 weeks (“treatment period”)
      • Potential open-label treatment options following the treatment period
  • Materials needed prior to evaluation: No previous diagnosis of cognitive impairment
  • Costs: No costs will be charged for any of the study procedures. Parking will be validated for all study visits, and subjects will be reimbursed about $100 per visit.  

 

Top of page

 

 


 

 

 

Anti-tau Antibody in Early Alzheimer’s (AbbVie)

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease. The purpose of this study is to test the efficacy of ABBV-8E12 in slowing disease progression (cognitive and functional impairment) in subjects with Early Alzheimer’s Disease. ABBV-8E12 is an immunotherapy (antibody drug) designed to bind to the tau protein and to try to prevent it from spreading throughout the brain and continuing to build up in brain cells.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: AbbVie
  • Recruiting?: Yes
  • Official study title: A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease.
  • ClinicalTrials.gov identifier: NCT02880956
  • Conditions studied: Alzheimer’s Disease
  • Intervention Drugs: ABBV-8E12 (a monoclonal antibody) and placebo control. Study drug (ABBV-8E12 or placebo) will be administered every 4 weeks as an intravenous infusion over 60 – 150 minutes based on subject’s body weight, every 4 weeks for 96 weeks.
  • Study Type: Interventional
  • Phase: Phase 2
  • Duration of participation: The expected time the subject will be in the study is 2 – 2.5 years. At the end of the treatment period, eligible subjects who completed the 96-week treatment period may enter a planned separate extension study for extended treatment.
  • IRB #: Pro00016879
  • IRB approval date: 7/7/2017

Eligibility
Inclusion criteria: 

  • Subjects must be between 55 years to 85 years (inclusive) of age.
  • Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:
    • Clinical Dementia Rating (CDR)-Global Score of 0.5
    • Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
  • Subject has a positive amyloid Positron Emission Tomography (PET) scan.
  • Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.
  • The subject has an identified, reliable, study partner (e.g., family member).
  • If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.

Exclusion criteria: 

  • Subject has any contraindications or inability to tolerate to brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.
  • Subject has evidence of any other clinically significant neurological disorder other than Early AD.
  • In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness or has had an infection requiring medical intervention in the past 30 days.
  • Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.

What is involved?

  • Procedures: Eligible subjects will be randomized to one of the 3 ABBV-8E12 dose arms (300 mg, 1000 mg, or 2000 mg) or placebo in a 1:1:1:1 ratio. Subjects will receive the study drug (or placebo) infusion every 4 weeks for 96 weeks. Subjects will also have following procedures: Brain MRIs, Amyloid PET scans, lumbar punctures, neurological and physical examinations, cognitive testing and questioning, ECGs, blood specimen collection, vital signs
  • Frequency of visits:
      • Up to 8 weeks screening period
      • Visits once every 4 weeks for 96 weeks (“treatment period”)
      • Follow-up period of approximately 20 weeks
      • Eligible subjects will be enrolled into the treatment period on Day 1 and receive their first infusion of the study drug. Subjects will return to the study site every 4 weeks for their study drug infusion, blood collection, study procedures and assessments.
  • Costs: No costs will be charged for any of the study procedures. Subjects will be reimbursed as follows:
    • Screening Visits (includes all visits required to complete screening procedures):  $200
    • Weeks 12 and 96:  $200 each visit if spinal tap is performed, $100 each visit if spinal tap is not performed
    • All other Treatment Visits:  $100 each visit
    • Post-Treatment Weeks 104 and 112 (if applicable):  $100 each visit
    • An additional travel reimbursement of up to $40 is available for each unscheduled visit and each visit that occurs over multiple days.
    • Subjects will be paid after they have completed each visit, even if they do not complete the overall study.

 

Top of page

 

 

 


 

 

Memory Improvement through Nicotine Dosing (MIND) Study

The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with MCI. Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function.
Summary

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor:  National Institute on Aging (NIA)
  • Recruiting?: Yes
  • Official study title: Long-Term Nicotine Treatment of Mild Cognitive Impairment.
  • ClinicalTrials.gov identifier: NCT02720445
  • Conditions studied: Mild Cognitive Impairment
  • Intervention Drugs: Nicotine Transdermal patch and control placebo patch. Study drug (nicotine patches or matching placebo patches) will be worn during waking hours.
  • Study type: Interventional
  • Phase: Phase 2
  • Duration of participation: The expected time the subjects will be in this study is approximately 2 years.
  • IRB #: Pro00016502
  • IRB approval date: 4/19/2017

Eligibility
Inclusion criteria: 

  • Participant must have a subjective memory concern as reported by participant, study partner, or clinician
  • Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale-Revised:
    • Less than or equal to 11 for 16 or more years of education
    • Less than or equal to 9 for 8 - 15 years of education
    • Less than or equal to 6 for 0 - 7 years of education
  • Mini-Mental State Exam score between 24 and 30, inclusive
  • Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5
  • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease dementia cannot be made by the site clinician at the time of the screening visit
  • Age 55-90 (inclusive)
  • Stable permitted medications for 4 weeks or longer as specified in Section 6.10, including:
    • Memantine is allowable if stable for 12 weeks prior to screen
  • Geriatric Depression Scale score of less than or equal to 9
  • Study Partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the participant to most visits to answer questions about the participant
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Good general health with no additional diseases/disorders expected to interfere with the study
  • Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
  • Completed six grades of education or has a good work history
  • Must speak English fluently

Exclusion criteria: 

  • Any use of tobacco or nicotine products within the past year, such as smoking cigarettes, pipes, cigars, etc.) or use of other nicotine products (chewing tobacco, e-cigarettes, nicotine patches, gum, sprays, etc.).
  • Any significant neurologic disease such as Alzheimer’s disease dementia, Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
  • Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
  • History of schizophrenia (DSM V criteria)
  • History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
  • Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject’s ability to participate in the study.
  • Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
  • Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
  • Clinically significant abnormalities in screening laboratories or ECG.
  • Residence in a skilled nursing facility.
  • Use of any excluded medication as described in Section 6.10, including:
    • Use of cholinesterase inhibitors or centrally acting pro- or anticholinergic drugs
    • Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
  • For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening
  • For MRI sub-study participants, contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
  • Participants whom the Site PI deems to be otherwise ineligible.

What is involved?

  • Testing and procedures: Neurological and physical examinations, cognitive testing and thinking skills tests (both written – using a paper and pen, and on electronic device like a computer or iPad), Behavioral tests, ECG, blood (for routine laboratory tests, genetic testing, biomarker research tests, and to measure level of nicotine in your blood) and urine specimen collection, vital signs, Study drug dispensation and, Research Satisfaction Survey.
  • Frequency of visits:
    • Total 12 visits including:
      • Screening visit:  ( 3-5 hours)
      • Baseline period:  Total 5-6 hours over the course of 2 days
      • 10 Visits during “treatment period”:   (1-4 hours each)
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, the nicotine patch, and tests related to the study. Subjects will receive $50 to help pay for gas and time coming to the visit. 

 

Top of page

 

 


 

 

BACE-inhibitor to Decrease Beta-amyloid in Mild Alzheimer's (Lilly)

The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer disease (AD) dementia.
LY3202626 is an inhibitor of BACE1 (BACE is an enzyme involved in the production of Aβ peptide (amyloid) – involved in the pathogenesis of Alzheimer’s disease). The treatment with this base inhibitor is sometimes envisioned as long-term maintenance therapy to limit the production of brain protein (amyloid) thought to cause Alzheimer’s disease.
Summary

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor:  Eli Lilly and Company
  • Recruiting?: Yes
  • Official study title: Effect of LY3202626 on Alzheimer's disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia.
  • ClinicalTrials.gov identifier: NCT02791191    
  • Conditions studied: Alzheimer’s disease
  • Intervention Drugs: LY3202626 and placebo control.
  • Study type: Interventional
  • Phase: Phase 2
  • Duration of participation: The expected time the subjects will be in this study is approximately 64 weeks, which is about 1 year and 3 months.
  • IRB #: Pro00014709
  • IRB approval date: 7/14/2016

Eligibility
Inclusion criteria: 

  • Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
  • Mini-Mental State Examination score of 20 to 26 inclusive at the screening visit.
  • Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.

Exclusion criteria: 

  • Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
  • Ocular pathology that significantly limits the ability to reliably evaluate vision or the retina.
  • Use of strong inducers of cytochrome P450 3A (CYP3A) within 30 days before baseline.
  • Sensitivity to florbetapir or ¹⁸F-AV-1451.
  • Contraindication to MRI or PET or poor venous access for blood draws.

What is involved?

  • Testing and procedures: Eligible subjects will be randomized to one of the two LY3202626 dose arms (3 mg, or 120 mg) or placebo in a 1:1:1 ratio. Subjects will receive the study drug (or placebo) for 52 weeks.
  • Subjects will also have following procedures: Brain MRIs, Amyloid PET scans, Tau PET scans,  lumbar punctures, neurological and physical examinations, skin and eye exams, cognitive testing, ECGs, blood (for routine laboratory tests, measuring drug levels, for  antibodies, genetic and biomarkers research) and urine specimen collection, vital signs
  • Frequency of visits:
    • Total 18-20 visits including:
      • 2 Screening visits:  ( 3-5 hours)
      • 16 Visits during “treatment period”:   (1-4 hours each)
      • 1 Follow-up visit
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, the study drug, and tests related to the study. Subjects and their study partner will receive $40 per study visit to help reimburse you for transportation expenses related to your taking part in this study.  The study partner will receive an inconvenience fee at each clinic visit of $25 except for visits 3, 8, 11 and early Discontinuation (if applicable) in which the reimbursement will be at the rate of $50 for the subject and at rate of $50 for the study partner.

 

Top of page

 

 


 

 

Treatment of Agitation in Alzheimer’s disease

The purpose of the study is to test the safety, efficacy, and tolerability of the study drug, AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type.

AVP-786 is a combination of two medications; one medication is a modified form of dextromethorphan and other is Quinidine, given in a very low dose. The original form of dextromethorphan has been in use for over 50 years and is commonly used in cough syrup. Quinidine is one of the oldest prescription drugs available and is used at higher doses to help control irregular heartbeats. NUEDEXTA®, an FDA approved medication that has some similarities to AVP-786, has been prescribed for tens of thousands of people.
Summary

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor:  Avanir Pharmaceuticals
  • Recruiting?: Yes
  • Official study title: A Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deuterated [d6]-dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type.
  • ClinicalTrials.gov identifier: NCT02442778    
  • Conditions studied: Agitation in patients with dementia of the Alzheimer’s type.
  • Intervention Drugs: AVP-786 and control placebo patch. Study drug (AVP-786 or placebo) will be taken orally (hard gelatin capsules).
  • Study type: Interventional
  • Phase: Phase 3
  • Purpose: The purpose of the study is to test the safety, efficacy, and tolerability of the study drug, AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type.
  • Duration of participation: The expected time the subjects will be in this study is approximately 16 weeks, with up to 4 weeks of screening period.
  • IRB #: Pro00014475
  • IRB approval date: 6/10/2016

Eligibility
Inclusion criteria: 

  • Patients between 50 – 90 years of age.
  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
  • The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Either outpatients or residents of an assisted-living facility or a skilled nursing home
  • Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >=4 (moderately ill) at screening and baseline
  • Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion criteria: 

  • Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participant with myasthenia gravis

What is involved?

  • Testing and procedures: Neurological and physical examinations, cognitive testing and thinking skills, Functional Behavioral tests, ECGs, blood and urine specimen collection, vital signs, Study drug dispensation.
  • Frequency of visits:
    • Total 6 - 8 visits including:
      • Screening visit
      • Baseline visit
      • Treatment period:    around 5 visits
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, the study drug, and tests related to the study. Subjects will receive $100 for each visit to the clinic that helps pay for gas and time coming to the visit. Subjects will receive $25 for each completed telephone visit.

 

Top of page

 

 


 

Tau Antibody in Early Alzheimer’s Disease (Lilly) – Periscope Study

The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of Ly3303560 in patients diagnosed with Alzheimer’s Disease (AD) or Mild AD.  LY3303560 is an investigational antibody expected to target the abnormal tau protein present in the brain of patients with AD. Secondary objectives are evaluation of the efficacy of multiple doses of LY3303560 in moderating cognitive and functional impairment in participants with mild cognitive impairment (MCI) due to AD or mild to moderate AD in comparison with placebo.  Progression of tau associated with AD will be assessed by positron emission tomography (PET). Progression of brain atrophy will be assessed by volumetric magnetic resonance imaging (MRI).

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Eli Lilly and Company
  • Recruiting?: Yes
  • Official study title:  Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer’s Disease
  • ClinicalTrials.gov identifier:  NCT03518073
  • Conditions studied: Mild Cognitive Impairment (MCI) as a result of Alzheimer’s Disease (AD) or mild to moderate AD, early AD
  • Intervention Drugs: LY3303560 in comparison with placebo
  • Study Type: Interventional
  • Study Phase: 2
  • Duration of participation: The expected time the participant will be in the study is approximately 136 weeks.  This includes a required 22 clinical outpatient visits, after an 8 week screening period which determines eligibility, a 76 week trial period, and a follow-up 52 weeks after completion.
  • IRB #: PRO00018797
  • IRB approval date: 04/11/2018

Eligibility
Inclusion criteria: 

  • Participants must be between 60 years to 85 years.
  • Ability of the participant or their informant/study partner and/or legally authorized representative to understand the purpose and risk and provide a signed and dated informed consent
  • Must have gradual and progressive change in memory function over more than 6 months, reported by the participant and/or their study partner
  • Study partner must agree to accompany the participant to clinic visits or be available by phone at designated times to provide information about the participant.  This will be approximately 10 hours per week.
  • Must speak English fluently.

Exclusion criteria:

  • Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study
  • Participants must not have serious or unstable illness that could interfere with analysis of the study, or have a life expectancy <24 months
  • Participants must not have a history of cancer within the last 5 years
  • Participants must not have a serious risk of suicide
  • Participants must not have a history of drug or alcohol abuse within the last 2 years
  • Participants must not have multiple severe drug allergies
  • Participants must not have HIV, Hepatitis B or Hepatitis C

What is involved?

  • Testing and Procedures: History, physical and neurological examination, cognitive testing, blood (for genetic testing and safety labs) and urine specimen collection, Brain MRIs, PET scans, electrocardiograms,  and study drug  infusions
  • Frequency of visits: There are 25 planned clinic visits during the study over approximately 136 weeks including the following:
    • Screening period – 1 visit with up 8 weeks (56 days) for evaluation of screening tests for enrollment.
    • Treatment period - 22 visits (one visit every 4 weeks when study treatment will be administered). 
    • 1 end of study visit at Week 80
    • 1 follow-up safety visit at Week 136

The study doctor may request you attend for additional unscheduled visits for safety or before you start or change your AD medication
Costs: There are no costs associated with participation in the study.  A $50 stipend will be provided to help cover your expenses related to the study for each completed study visit.  You will receive the checks by mail from Houston Methodist.

 

Top of page

 

 


 

Pimavanserin in Dementia-related Psychosis

The purpose of this study is to evaluate the efficacy of Pimavanserin by comparing with placebo in preventing a relapse of psychotic symptoms in subjects with dementia-related psychosis.  Other than relapse of dementia-related psychosis, the study also seeks to evaluate the effect of Pimavanserin on the symptoms of hallucinations and delusions, caregiver burden, daytime sleepiness, and general quality of life.

  • Study Director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor:  ACADIA Pharmaceuticals Inc.
  • Recruiting? Yes
  • Official study title: A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
  • ClinicalTrials.gov identifier: NCT03325556
  • Conditions Studied: Dementia-related Psychosis
  • Intervention Drugs: Pimavanserin
  • Study type: Intervention Study
  • Study Phase: 3
  • Duration of participation: The expected time the subject is expected to participate is approximately 46 weeks
  • IRB #: Pro00017966
  • IRB Approval Date: 2/14/2018

Eligibility
Inclusion Criteria:

  • Meets clinical criteria for one of the following disorders: Dementia associated with Parkinson’s Disease, Dementia with Lewy bodies, Possible or probable Alzheimer’s disease, Frontotemporal spectrum disorders, Vascular dementia
  • Had psychotic symptoms for at least 2 months
  • Age 50 to 90 years
  • Has a designated study partner/caregiver to come to study visits and accurately report on subjects symptoms and confirm subject is taking the drug, as well as participate in assessments and provide written consent for the study

Exclusion Criteria:

  • Has psychotic symptoms that are primarily attributable to a condition other than dementia
  • Has had a major depressive episode
  • Has experienced suicidal ideation or behavior within 3 months of study enrollment
  • Has evidence of non-neurological medical comorbidity or medication that could substantially impair cognition
  • Has a ischemic stroke within the last 12 months or any evidence of a hemorrhagic stroke
  • Has a known cerebral amyloid angiopathy, epilepsy, CNS neoplasm, or unexplained syncope
  • Has a significant unstable medical condition that could interfere with the subject’s ability to complete the study or comply with study procedures
  • Requires treatment with a medication or other substance that is prohibited by the protocol

Additional inclusion/exclusion criteria may apply.  Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
What is involved?
Testing and Procedures: History, Physical and Neurological examinations, ECGs, Brain MRIs or CT scan, Blood and urine specimen collection, Psychological testing, Genetic testing (optional), Study partner/caregiver questionnaire, psychosocial therapy training for study partner/caregiver, Audio recording of assessments/interviews evaluating symptoms of subjects
Frequency of visits:
The duration of the study is up to 46 weeks, including:

  • Screening period (3-28 days)
  • Open-label period (12 weeks)
  • Double-blind period (up to 26 weeks)
  • Safety follow-up period (approximately 4 weeks

You will have

  • 15 clinic visits at Houston Methodist Neurological Institute
  • 2 telephone calls
  • 1 follow-up phone call
Costs: There is no charge to participants of the study.  The study-drug, study related procedures, and study visits will be provided at no charge.  For participation in the study, the subject will be paid a stipend of $107 for every completed visit.

 

Top of page

 

 


 

 

Anti-tau Antibody in Mild Cognitive Impairment and Alzheimer’s disease – Tango Study

This study evaluates use of two anti-amyloid therapies with different mechanisms of action targeting the amyloid cascade.
LY3002813 is an antibody being studied for the treatment of Alzheimer’s disease (AD). The mechanism of action of LY3002813 is considered to be the targeting and removal of existing amyloid plaque, which is a key pathological hallmark of AD.
LY3202626 is an inhibitor of β-site amyloid precursor protein (APP)-cleaving enzyme [BACE]1, being assessed for the treatment of AD in an ongoing phase 2 study. The mechanism of action of LY3202626 is considered to be the reduction of Aβ monomer production through BACE 1 inhibition.
This Study will assess whether removal of existing amyloid plaque alone or in combination with lowering of Aβ production via BACE inhibition can slow the progression of disease as assessed by clinical measures and biomarkers of disease pathology and neurodegeneration over up to 76 weeks of treatment.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Eli Lilly and Company
  • Recruiting?: Yes
  • Official study title:  Assessment of Safety, Tolerability and Efficacy of LY3002813 Alone and in Combination with LY3202626 in Early Symptomatic Alzheimer’s Disease
  • ClinicalTrials.gov identifier:  NCT03367403
  • Conditions studied: Mild Cognitive Impairment (MCI) as a result of Alzheimer’s Disease (AD) or mild to moderate AD, early AD
  • Intervention Drugs: LY3002813, LY3002813 and LY3202626, in comparison with placebo
  • Study Type: Interventional
  • Study Phase: 2
  • Duration of participation: The expected time the participant will be in the study is approximately 132 weeks.  This includes a required 22 clinical outpatient visits, after an 8 week screening period which determines eligibility, a 76 week trial period, and a follow-up 52 weeks after completion.
  •  IRB #: Pro00019214
  • IRB approval: 3/15/2018

Eligibility

Inclusion criteria: 

  • Participants must be between 60 years to 85 years.
  • Ability of the participant or their informant/study partner and/or legally authorized representative to understand the purpose and risk and provide a signed and dated informed consent
  • Must have gradual and progressive change in memory function over more than 6 months, reported by the participant and/or their study partner
  • Must speak English fluently.

Exclusion criteria:

  • Ocular pathology that significantly limits ability to reliably evaluate vision or the retina
  • Contraindication to MRI

Additional inclusion/exclusion criteria may apply.  Participants will be evaluated at screening to ensure that all criteria for study participation are met.

What is involved?

  • Testing and Procedures: History, Physical and neurological examination, Eye exam, Skin  exam, cognitive testing, blood (for genetic and safety labs) and urine specimen collection, Brain MRIs, PET scans, electrocardiograms, study drug infusions, study drug (oral) medication
  • Frequency of visits: There are 25 planned clinic visits during the study over approximately 136 weeks including the following:
    • Screening period – 1 visit with up 8 weeks (56 days) for evaluation of screening tests for enrollment.
    • Treatment period - 22 visits (one every 4 weeks when study treatment will be administered). 
    • 1 end of study visit at Week 80
    • 1 follow-up safety visit at Week 136

The study doctor may request that you attend additional unscheduled visits for safety or before you start or change your AD medication

Costs: There are no costs associated with participation in the study.  A $50 stipend will be provided to help cover your expenses related to the study for each completed study visit.  You will receive the checks by mail from Houston Methodist.

 

Top of page

 

 


 

 

Glutathione in Mild Cognitive Impairment

The goal of this study is to evaluate potential improvement in cognition from ingesting proteins N-acetylcysteine and glycine every day for 12 weeks.  It also seeks to evaluate potential improvement in the efficiency of the body to process glucose, lower oxidative stress and improve endothelial function.

  • Study director (local PI): Rajagopal Viswanath Sekhar, MD, BS
  • Co-Investigator: Joseph C. Masdeu, MD, PhD
  • Sponsor: NIH: National Institute of Health
  • Recruiting?: Yes
  • Official study title:  Glutathione in Mild Cognitive Impairment
  • ClinicalTrials.gov identifier:  NCT03493178
  • Conditions studied: Mild Cognitive Impairment (MCI)
  • Intervention Drugs: Glutathione, N-acetylcysteine and glycine
  • Study Type: Observational
  • Study Phase: N/A
  • Duration of participation: The expected time the participant will be in the study is approximately 6 months. 
  • IRB #: Pro00018465
  • IRB approval: 12/27/2017

Eligibility

Inclusion criteria: 

  • Participants must be between 55 and 85 years of age and have cognitive impairment.
  • Cease over the counter health supplements for 6 months
  • Must speak English or Spanish fluently.

Exclusion criteria:

  • Hospitalization within the last 3 months
  • Known diabetes or liver disease
  • History of stroke, brain tumor or active treatment for heart failure
  • History of psychiatric disorders or untreated depression

What is involved?

  • Testing and Procedures: Physical and neurological examination, cognitive testing, blood and urine tests, vital signs and patient history, medication by pills, metabolic testing, endoPAT, fasting required
  • Frequency of visits: There are 7 planned clinic visits during the study over approximately 6 months including the following:
    • 1 screening visit for evaluation of screening tests for enrollment.
    • 6 additional outpatient visits (intervals are variable based on screening). 
Costs: There are no costs associated with participation in the study.  A $150 stipend will be provided to help cover your expenses related to the study after visit 3 and visit 6.  A $200 stipend will be provided after visit 7.  You will receive the checks by mail from Baylor College of Medicine.

 

 

Top of page

 

 


 

Antibody and BACE Inhibitor in Alzheimer’s disease

This study evaluates use of two anti-amyloid therapies with different mechanisms of action targeting the amyloid cascade.
LY3002813 is an antibody being studied for the treatment of Alzheimer’s disease (AD). The mechanism of action of LY3002813 is considered to be the targeting and removal of existing amyloid plaque, which is a key pathological hallmark of AD.
LY3202626 is an inhibitor of β-site amyloid precursor protein (APP)-cleaving enzyme [BACE]1, being assessed for the treatment of AD in an ongoing phase 2 study. The mechanism of action of LY3202626 is considered to be the reduction of Aβ monomer production through BACE 1 inhibition.
This Study will assess whether removal of existing amyloid plaque alone or in combination with lowering of Aβ production via BACE inhibition can slow the progression of disease as assessed by clinical measures and biomarkers of disease pathology and neurodegeneration over up to 76 weeks of treatment.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Eli Lilly and Company
  • Recruiting?: Yes
  • Official study title:  Assessment of Safety, Tolerability and Efficacy of LY3002813 Alone and in Combination with LY3202626 in Early Symptomatic Alzheimer’s Disease
  • ClinicalTrials.gov identifier:  NCT03367403
  • Conditions studied: Mild Cognitive Impairment (MCI) as a result of Alzheimer’s Disease (AD) or mild to moderate AD, early AD
  • Intervention Drugs: LY3002813, LY3002813 and LY3202626, in comparison with placebo
  • Study Type: Interventional
  • Study Phase: 2
  • Duration of participation: The expected time the participant will be in the study is approximately 132 weeks.  This includes a required 22 clinical outpatient visits, after an 8 week screening period which determines eligibility, a 76 week trial period, and a follow-up 52 weeks after completion.
  • IRB #: PRO00018797
  • IRB approval: 3/15/2018

Eligibility

Inclusion criteria: 

  • Participants must be between 60 years to 85 years.
  • Ability of the participant or their informant/study partner and/or legally authorized representative to understand the purpose and risk and provide a signed and dated informed consent
  • Must have gradual and progressive change in memory function over more than 6 months, reported by the participant and/or their study partner
  • Must speak English fluently.

Exclusion criteria:

  • Ocular pathology that significantly limits ability to reliably evaluate vision or the retina
  • Contraindication to MRI

Additional inclusion/exclusion criteria may apply.  Participants will be evaluated at screening to ensure that all criteria for study participation are met.

What is involved?

  • Testing and Procedures: History, Physical and neurological examination, Eye exam, Skin  exam, cognitive testing, blood (for genetic and safety labs) and urine specimen collection, Brain MRIs, PET scans, electrocardiograms, study drug infusions, study drug (oral) medication
  • Frequency of visits: There are 25 planned clinic visits during the study over approximately 136 weeks including the following:
    • Screening period – 1 visit with up 8 weeks (56 days) for evaluation of screening tests for enrollment.
    • Treatment period - 22 visits (one every 4 weeks when study treatment will be administered). 
    • 1 end of study visit at Week 80
    • 1 follow-up safety visit at Week 136

The study doctor may request that you attend additional unscheduled visits for safety or before you start or change your AD medication

Costs: There are no costs associated with participation in the study.  A $50 stipend will be provided to help cover your expenses related to the study for each completed study visit.  You will receive the checks by mail from Houston Methodist.

 

Top of page

 

 


 

 

Alzheimer’s Disease Neuroimaging Initiative 3 (ADNI3)

Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in Alzheimer's disease (AD). ADNI3 will continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research. This study will determine and define those measures of cognition and function, including composite measures, and those biomarker measures, which capture longitudinal change to detect treatment effects in clinical trials. Longitudinal change of cerebral tau measured with positron emission tomography (PET) scan will be correlated and compared with other measures. ADNI3 will determine which clinical, cognitive, and biomarker measures best predict the decline of cognition in Cognitively Normal (CN), Mild Cognitively Impaired (MCI) and AD participants. In addition, will determine which biomarker changes correlate with cognitive decline. This study is also aiming to determine the effects of other known disease proteins found in AD brains and genes, as well as newly discovered genes, proteins, and analytes that provide useful information concerning the pathogenesis / diagnosis of AD.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: This study is being funded by grants from National Institute on Aging (NIA) and U.S. Department of Defense.
  • Recruiting?: Yes
  • Official study title: Alzheimer’s Disease Neuroimaging Initiative 3 (ADNI3).
  • ClinicalTrials.gov identifier:  NCT02854033
  • Conditions studied: Alzheimer’s Disease (AD), Mild Cognitively Impaired (MCI) and Cognitively Normal (CN) participants.
  • Intervention Drugs: Drugs are not given in this study.
  • Study Type: Observational Study
  • Duration of participation: The expected time the subject will be in the study is between 3 and 5 years, depending on which study group the participant fit in.
  • IRB #: Pro00016334
  • IRB approval date: 7/7/2018
Eligibility
Inclusion criteria: 
  • Subjects must be between 55 years to 90 years (inclusive) of age.
  • Have a study partner who has frequent contact with the participant.
  • Visual and auditory acuity adequate for neuropsychological testing.
  • Participant is not pregnant, lactating, or of childbearing potential.
  • Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
  • Must speak English or Spanish fluently.
  • Willing to undergo repeated MRIs and at least two PET scans.
  • Agrees to collection of blood for genomic analysis, APOE testing, biomarker testing and bio-specimen banking.
  • Agrees to at least one lumbar puncture for the collection of CSF.
  • Agrees to share genomic data and biomarker samples.

For "Cognitively Normal" Subjects:

  • Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age.
  • Mini-Mental State Exam score between 24 and 30 inclusive.

For "MCI (Minimal Cognitive Impairment) Adults":

  • Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.
  • Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director).
  • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease cannot be made by the site physician at the time of the Screening Visit.

For "Alzheimer's Disease" Patients:

  • Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.
  • Mini-Mental State Exam score between 20 and 24 inclusive.

Exclusion Criteria: 
All participants must not meet the following criteria:
For 'Cognitively Normal' Subjects and for MCI Subjects:

  • Any significant neurologic disease, such as Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.

For 'Alzheimer's Disease' Patients:

  • Any significant neurologic disease other than Alzheimer’s disease, such as Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.

The following additional exclusion criteria apply to all diagnostic categories:
Exclusion Criteria Specific to AV-1451 PET:
The following criteria are exclusionary only for the AV-1451 scanning portion of the study:

  • History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided.
  • Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject’s participation in the study. Bazett’s corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females.
What is involved?
  • Testing and Procedures: History, Clinical and Neurological Examination, Memory and Thinking Skills tests, Computer based Memory testing, Psychological testing, Brain MRIs, Amyloid PET scans, Tau PET scans, FDG PET scans, lumbar punctures, ECGs, blood specimen collection (for biomarker and genetic testing), and vital signs.
  • Frequency of visits:
    • Screening visit – 1
    • Baseline visit – 1
    • Annual visits
      • Cognitively Normal participants – 4 visits
      • Mild Cognitively Impaired participants – 4 visits
      • Alzheimer’s Disease participants – 2 visits
  • Costs: No costs will be charged for any of the study procedures. To compensate the time you take to undergo the procedures in this study, you will receive $50 for each MRI study, $150 for each PET study and $190 for each lumbar puncture. These amounts will be paid to you approximately one month after completing each procedure.

 

 

Top of page

 

 


 

 

AV1451 Pathology Validation Study

This study is designed to test the relationship between ante-mortem 18F-AV-1451 Positron Emission Tomography (PET) and tau neurofibrillary pathology associated with Alzheimer's disease (AD), as measured at autopsy.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor: Avid Radiopharmaceuticals
  • Recruiting?: No
  • Official study title: A Clinico-Pathological Study of the Correspondence Between 18F-AV-1451 PET Imaging and Post-Mortem Assessment of Tau Pathology
  • ClinicalTrials.gov identifier: NCT02516046
  • Conditions studied: Alzheimer’s Disease
  • Intervention Drugs: Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicuries [mCi]) of 18F-AV-1451. Some subjects may receive a second injection after 6 months have passed since the first injection.
  • Phase: Phase 3
  • Duration of participation: The expected time for participation in the study is 9 months; however, if the subject agrees to the 2nd PET with 18F-AV-1451, the participation time could possibly be an additional 6 month.
  • IRB #: Pro00013552
  • IRB approval date: 2/23/2016

Eligibility
Inclusion criteria: Subjects must be 50 years and older and have a projected life expectancy of ≤ 6 months as determined by the principal investigator (terminal medical condition such as end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease [COPD], end-stage renal disease, or end-stage cancer), and can tolerate a 20 minute PET scan, and can give informed consent or have a legally authorized representative (LAR) to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die.
Exclusion criteria: Subjects must not be aggressively being treated with life-sustaining measures, have a clinically significant infectious disease, known to have a structural brain lesion that would interfere with PET imaging or pathological assessment, currently receiving any investigational medications except with permission from the study sponsor, participated in an experimental study with an amyloid or tau targeting agent. Subjects must not have suspected encephalopathy due to alcoholism or end-stage liver disease. Subjects must not have risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation. Females of childbearing potential are also excluded to participate in this study.

What is involved?

  • Testing: 18F-AV-1451 PET scan, brief neurological and physical examinations, cognitive testing, vital signs,   Brain MRI (collection of MRI that was done within the last 12 months) autopsy (a brain-only autopsy will be performed if death occurs within 9 months of the most recent 18F-AV-1451 PET scan)
  • Frequency of visits: 2
    • Within 45-days of screening visit.
  • Costs: No costs will be charged for any of the study procedures. Parking will be validated for all study visits, and subjects will be reimbursed between $200 per visit. 

 

Top of page

 

 

 


 

 

Blood markers of mTBI

We want to learn about markers (proteins) in the blood that might be able to tell doctors if a patient has a mild traumatic brain injury (TBI).  Marker levels might increase or decrease in the blood when a patient has a TBI.  These researchers will be testing for markers that are known to change in patients with a TBI and will also be storing your blood to use in later studies to look for new (currently undiscovered) markers for TBI.
Only those subjects that are participating in GE imaging study (Advanced MRI Applications for Mild Traumatic Brain Injury) will be offered to participate in this study.

  • Study director (local PI): Joseph C. Masdeu, MD, PhD
  • Sponsor:  Abbott Laboratories
  • Recruiting?: No
  • Official study title: Blood Biomarker Candidate Study for Mild Traumatic Brain Injury
  • Conditions studied: Mild traumatic brain Injury
  • Intervention Drugs: N/A.
  • Duration of participation: The expected time you will be in the study is about 4 months.
  • IRB #: Pro00012148
  • IRB approval date: 1/5/2015

Inclusion criteria: 
Be enrolled in the GE Imaging Study (phase 2)

  • Be age ≥ 15 and ≤50 years old at time of enrollment
  • Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment in one of the two intervals of the study, as follows:
    • Meets criteria for enrollment in Encounter 1 (within 72 hours)
    • Meets criteria for enrollment in Encounter 2 (within 8±2 days)
  • Be willing to participate in all study activities and provide written informed consent for participation
  • Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors

Exclusion criteria: 
Not enrolled in the GE Imaging Study (phase 2)

What is involved?

  • Testing:  Blood specimen collection.
  • Frequency of visits:
      • 3 to 5 study visits
      • The blood draws of 3 tablespoons (40 milliliters) will be done when you come to the hospital for the MRI or other testing associated with the GE Imaging Study.
  • Materials needed prior to evaluation: Enrollment in GE- Imaging study (as mentioned in introduction)
  • Costs: No costs will be charged for any of the study procedures. You will be paid $80 for each blood draw done for this study.  If you enroll in the study within 72 hours of your head injury, you will have 5 blood draws and will be given up to $400.  If you enroll in the study within 8 days of your head injury, you will have 3 blood draws and will be given up to $240. 

 

Top of page

 

 

 


 

 

Chronic severe TBI: tau and inflammation PET

People who have suffered a traumatic brain injury (TBI) may experience cognitive, behavioral and physical deficits that may interfere with interpersonal, social and occupational activities.  TBI could lead to progressive worsening, a process called chronic traumatic encephalopathy (CTE).  At autopsy, CTE is associated with brain inflammation and with excess amounts in the brain of two abnormal proteins, called tau and amyloid. If these could be detected while the person is still alive, this would greatly facilitate the discovery of therapies to prevent CTE.
We plan to use positron emission tomography (PET) scans to determine whether 1 year or longer after the injury there is an excess of tau, inflammation, and amyloid in the brain of someone who has experienced a moderate to severe TBI.  To determine progression, we will repeat the scans approximately 24 months later.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor:  Houston Methodist Hospital Research Foundation
  • Recruiting?: Yes
  • Official study title: [18F]AV-1451 PET to study tau in vivo in chronic severe traumatic brain injury: Correlation with inflammation and amyloid
  • Conditions studied: Moderate to severe traumatic brain injury.
  • Intervention Drugs: N/A.
  • Duration of participation: You will be expected to be in the study for about 2 years.
  • IRB #: Pro00014748
  • IRB approval date: 7/5/2016

Eligibility
Inclusion criteria:
Inclusion Criteria for TBI Subjects

  • Individuals of either sex, 18‐50 years of age
  • Who have sustained at least one year previously a traumatic brain injury with an initial Glasgow Coma Score of 3‐13
  • Having had an abnormal brain CT or MRI scan after the traumatic injury with a pattern consistent with an acute brain lesion
  • Fluent in English or Spanish
  • Have sufficient communication and comprehension ability to consent to the performance of the study or have a legally authorized representative

Inclusion Criteria for Healthy Volunteers

  • Individuals of either sex, 18‐85 years of age
  • Fluent in English
  • Have enough communication and comprehension ability to consent to the performance of the study

Inclusion Criteria for Controls with Chronic Traumatic Encephalopathy, Alzheimer’s disease, or Tau‐associated Frontotemporal Dementia

  • Individuals of either sex, 30‐85 years of age with the clinical diagnosis of CTE, AD, or tau‐associated FTD, such as non‐amyloid logopenic primary progressive aphasia, progressive supranuclear palsy or corticobasal degeneration
  • Fluent in English
  • Have enough communication and comprehension ability to consent to the performance of the study

Exclusion criteria: 
Exclusion Criteria for TBI Subjects

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • History of stroke unrelated to trauma, multiple sclerosis or other brain disorder that, in the judgment of the PI may confound the study
  • Active cancer, metabolic encephalopathy, or severe infection or cardiovascular disease
  • Active, severe hematological, renal, pulmonary, endocrine or hepatic disorders, uncorrected by treatment
  • Pregnancy

Exclusion Criteria for Healthy Volunteers

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • History of previous TBI of any kind
  • Brain disorder, other than an idiopathic headache
  • Current primary Axis I or II psychiatric disorder
  • Current use of psychotropic or anti‐epileptic medication
  • Substance abuse during the past two years
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease
  • Pregnancy

Exclusion Criteria for Controls with Chronic Traumatic Encephalopathy, Alzheimer’s disease, or
Tau‐associated Frontotemporal Dementia

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • Active cancer, metabolic encephalopathy, infection, severe cardiovascular disease
  • Pregnancy

What is involved?

  • Testing: Brain MRI, AV1451 PET scans, PBR28 PET scans, PIB PET scans, Blood specimen collection, Neurological and neuropsychological examinations.
  • Frequency of visits:
    • 7 visits, including screening visit
  • Costs: There will be no cost to you for your participation in the study.  All procedures and assessments will be paid for by the study team. To help pay for your parking, gas, and your time, you will receive $100 for each completed visit. 

 

Top of page

 

 

 



 

 

Hand Control in Alzheimer's Disease

The purpose of the research is to determine the changes in sensorimotor systems in patients with Alzheimer’s disease. We will examine how you can use visual and tactile sensory cues to learn to manipulate a novel object.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor: The University of Houston
  • Recruiting?: Yes
  • Official study title: Hand Control in Alzheimer's Disease  
  • Conditions studied: Alzheimer’s disease
  • Intervention Drugs: N/A 
  • Phase: Observational study
  • Duration of participation: The experimental session will last for about 2.5 hours
  • IRB #: Pro00014811
  • IRB approval date: 5/24/2016

Eligibility
Inclusion criteria:

  • Patients will be between 60 and 80 (inclusive) years of age and have a diagnosis of AD
  • All subjects must be willing and able to undergo all testing procedures
  • Older controls will be age and sex matched to the AD group
  • Younger controls will be ages 21-35 years, both inclusive; they will be sex-matched to the older groups

Exclusion criteria: 

  • Include significant or unstable medical illness (e.g., poorly controlled diabetes, active cancer), or clinically significant laboratory abnormalities on screening tests (e.g., untreated hypothyroidism)

What is involved?

  • Testing: Clinical and neuropsychological assessment, handedness test, and test to check the hand grasp.
  • Frequency of visits: 1 visit
  • Costs: You will receive $5/30 min in the form of Wal-Mart gift cards to help compensate for your time.  You will also receive a parking voucher.

 

Top of page

 

 

 

 



 

 

Inflammation in mTBI-PBR28

Persons who have suffered mild traumatic brain injury (mTBI) may experience cognitive problems and difficulties in interpersonal relationships. Some of these difficulties are caused by the brain disease itself, but doctors still do not understand well why this happens and therefore are limited in their ability to treat this problem.
Recent studies indicate that these problems could be associated brain inflammation. In order to clarify this issue, we plan to study brain inflammation in people with mTBI and healthy controls by means of a positron emission tomography (PET) scan, after the intravenous injection of a radioactive substance called [11C]PBR28. This study is likely to shed some light into why mTBI may cause problems with interpersonal relationships and cognition.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor:  Houston Methodist Hospital Foundation
  • Recruiting?: No
  • Official study title: [11C]PBR28 PET to study microglial activation following mTBI
  • Conditions studied: Mild traumatic brain injury
  • Intervention Drugs: N/A.
  • Duration of participation: You will be expected to be in the study for about thirteen months, on which period of time, you may have up to 5 visits.
  • IRB #: Pro00014287
  • IRB approval date: 8/3/2016

Eligibility
Inclusion criteria:
Inclusion Criteria for mTBI Subjects

  • Individuals of either sex, 18-40 years of age
  • Have sustained within the previous week an alteration in brain function caused by a process of sudden acceleration/deceleration of the brain. The alteration of brain function is defined by having one or more of the following clinical signs:
    • Any period of loss of or a decreased level of consciousness (LOC)
    • Any loss of memory for events immediately before (retrograde amnesia) or after the injury (Post-Traumatic Amnesia, PTA)
    • Neurologic deficits (weakness, loss of balance, change in vision, dyspraxia paresis/plegia [paralysis], sensory loss, aphasia, etc.)
    • Any alteration in mental state at the time of the injury (confusion, disorientation, slowed thinking, etc.) not due to intoxication, medications, or multiple trauma to other body regions
  • Fluent in English and have sufficient communication and comprehension ability to consent to the performance of the study
  • With a TSPO genotype that allows at least partial binding of [11C]PBR28

Inclusion Criteria for Healthy Volunteers

  • Individuals of either sex, 18-40 years of age
  • Fluent in English and have enough communication and comprehension ability to consent to the performance of the study
  • With a TSPO genotype that allows at least partial binding of [11C]PBR28

Inclusion Criteria for Controls with Chronic Traumatic Encephalopathy, Alzheimer’s disease, or Frontotemporal Dementia

  • Individuals of either sex, 30-90 years of age with the clinical diagnosis of CTE, AD, PSP or FTD
  • Fluent in English and have enough communication and comprehension ability to consent to the performance of the study
  • With a TSPO genotype that allows at least partial binding of [11C]PBR28

Exclusion criteria: 
Exclusion Criteria for mTBI Subjects

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • Being treated with steroids or large doses of other anti-inflammatory drugs
  • Loss of consciousness longer than 30 min in connection with the traumatic event
  • Post-traumatic amnesia lasting more than 24 hours after mTBI
  • Glasgow Coma Scale score lower than 13 after the mTBI
  • History of previous moderate to severe TBI
  • Brain disorder, other than idiopathic headache, prior to mTBI
  • Current primary Axis I or II psychiatric disorder
  • Current use of psychotropic or anti-epileptic medication
  • Substance abuse during the past two years
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease
  • Pregnancy

Exclusion Criteria for Healthy Volunteers

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • Being treated with steroids or large doses of other anti-inflammatory drugs
  • History of previous TBI of any kind
  • Brain disorder, other than idiopathic headache
  • Current primary Axis I or II psychiatric disorder
  • Current use of psychotropic or anti-epileptic medication
  • Substance abuse during the past two years
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease
  • Pregnancy

Exclusion Criteria for Controls with Chronic Traumatic Encephalopathy, Alzheimer’s disease, or Frontotemporal Dementia

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • Active cancer, metabolic encephalopathy, infection, severe cardiovascular disease
  • Being treated with steroids or large doses of other anti-inflammatory drugs, at the judgment of the PI
  • Pregnancy

What is involved?

  • Testing: History, Behavior, Blood specimen collection for genotyping, Neurological and neuropsychological examinations, Brain MRIs, PBR28  PET scans.
  • Frequency of visits: Usually 4 visits, but may have up to 5 visits.
  • Costs: The study will cover the cost of the clinical and neuropsychological examinations, the PET scan, and the MRI study. You will receive $100 per completed visit to help pay for parking and to compensate for your time.

 

Top of page

 

 

 


 

 

Neuroimaging in Cognitive Disorders

The purpose of this study is to evaluate the usefulness in cognitive disorders of several different tests, including various types of brain imaging, body fluid samples, measurements of memory and other thinking abilities, and measures of functional independence. We aim to identify the best imaging measures or other markers in the blood, urine, and cerebrospinal fluid for diagnosing AD and related disorders and for tracking changes over time. It is important to improve our ability to measure changes in AD and related disorders over time because these measures may help us advise patients and families about the rate of progression of the disease and will be very important for making decisions about whether new treatments work.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor: Nantz National Alzheimer Center, Houston Methodist Neurological Institute
  • Recruiting?: Yes
  • Official study title: Neuroimaging in Alzheimer Disease and related disorders
  • Conditions studied: Alzheimer’s disease; Healthy volunteers are also enrolled
  • Intervention Drugs: N/A.
  • Phase: Observational study
  • Duration of participation: Natural history study with serial evaluations, with the periodicity required by clinical management and relevant research questions, usually no more than once yearly and generally less often.
  • IRB #: Pro00007462
  • IRB approval date: 2/28/2013

Inclusion criteria: 
All enrolled subjects will be between 18 and 90 (inclusive) years of age and have a diagnosis of Alzheimer disease or a related disorder or a strong family history or other genetic risk factors for those diseases. They must be native in English or Spanish and willing to undergo MRI and PET scanning. All subjects must be willing and able to undergo all testing procedures, including neuroimaging and lumbar puncture, and agree to longitudinal follow-up.

Exclusion criteria: 
Include significant or unstable medical illness (e.g., poorly controlled diabetes, active cancer), clinically significant laboratory abnormalities on screening tests (e.g., thyroid function), contraindication to MRI including pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, the use of warfarin or presence of blood conditions that are a contraindication to lumbar puncture, and any contraindications to PET scanning, such as having reached the annual radiation dose prescribed by radiation safety guidelines.

What is involved?
Testing: Each evaluation may include clinical and neuropsychological examinations, a MRI scan, an 18F-Fluorodeoxyglucose PET scan, PIB PET scan or an 18F-florbetapir PET scan. In addition, blood (not to exceed 40 ml in each extraction) and urine will be collected and a lumbar puncture (optional) will be obtained for measurement of dementia-related biomarkers. 

  • Frequency of visits: Participants will have serial evaluations, with the periodicity required by clinical management and relevant research questions, usually no more than once yearly and generally less often, but always within the NIH limits of research radiation exposure.
  • Costs: You will only receive a small incentive amount for tests that involve some physical hardship, namely, $100 for a spinal tap. Parking passes will be validated.

 

Top of page

 

 

 


 

 

NMDA Receptor Antibodies in Psychosis

Schizophrenic and bipolar psychoses are chronic and disabling brain disorders that affect people of all backgrounds. It is thought that in the brain of people with schizophrenic psychosis there is a decreased amount of a receptor known as the N-acetyl methyl D-aspartate (NMDA) receptor, which normally facilitates thinking and memory. It is not known why this receptor is decreased, but a reasonable possibility is that in some people the receptor is being attacked by antibodies, produced by the body of the person with psychosis.

The goal of this study is to determine whether there are increased antibodies against the NMDA receptor in cerebrospinal fluid (CSF) and serum of people with psychosis, when compared with healthy controls. Recognizing this problem is critical because when the antibodies are lowered by treatment, the NMDA receptors recover, and the psychosis would be eliminated or at least greatly improved.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor:  The Schizophrenia Collaborative Fund
  • Recruiting?: Yes
  • Official study title: NMDA Receptor in Psychosis: Specific Auto-Antibodies
  • Conditions studied: Psychosis
  • Intervention Drugs: N/A.
  • Phase: Observational study
  • Duration of participation: The expected time you will be in the study is about 1 month.
  • IRB #: Pro00014773
  • IRB approval date: 9/30/2016

Inclusion criteria: 
Inclusion Criteria for Psychosis Subjects:

  • Individuals of either sex, 18-35 years of age
  • Admitted for a psychotic episode in its broadest definition, including manic psychosis
  • Normal academic performance at least until the age of 15 years and absence of psychiatric symptoms before the same age
  • Have sufficient communication and comprehension ability to assent or consent to the performance of the study. Both English and Spanish speaking subjects will be included

Inclusion Criteria for Healthy Volunteers:

  • Individuals of either sex, 18-35 years of age
  • Have enough communication and comprehension ability to consent to the performance of the study. Both English and Spanish speaking subjects will be included

Exclusion criteria: 
Exclusion Criteria for Psychosis Subjects

  • History of brain tumor, stroke, epilepsy, severe head trauma or multiple sclerosis
  • In the judgment of the PI, psychosis related to substance abuse or metabolic disorders
  • Active cancer, metabolic encephalopathy, infection, severe cardiovascular or renal disease
  • Current antiplatelet or anticoagulation medication

Exclusion Criteria for Healthy Volunteers

  • History of brain tumor, stroke, severe head trauma or multiple sclerosis
  • Primary Axis I or II psychiatric disorder
  • Current use of psychotropic or anti-epileptic medication
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders
  • Current antiplatelet or anticoagulation medication

What is involved?

  • Testing:  Lumbar punctures, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, blood specimen collection.
  • Materials needed prior to evaluation: Reports of EEGs and imaging procedures, such as brain CT or MRI (those that were done previously as a part of a standard of care), but removing from the information that could be traced them back to you.
  •  Costs: No costs will be charged for any of the study procedures. To compensate your time in the study, you will receive $150.00 once you have completed all the procedures of the study.

 

Top of page

 

 

 


 

 

Social Cognition and Neuroimaging in FTD

People with some diseases that affect the brain, such as Alzheimer’s disease or fronto-temporal dementia, may experience difficulties in interpersonal relationships. Some of these difficulties are caused by the brain disease itself, but doctors still do not understand well why this happens and therefore are limited in their ability to treat this problem.
In order to clarify this issue, we plan to study the response of people with Alzheimer’s disease or fronto-temporal dementia to interpersonal relationship situations. We will also study their brain by means of magnetic resonance imaging (MRI) and positron emission tomography (PET). This study is likely to shed some light into why these diseases may cause problems with interpersonal relationships.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor: Nantz National Alzheimer Center, Houston Methodist Neurological Institute
  • Recruiting?: Yes
  • Official study title: Neuroimaging Correlates of Social Cognition in Frontotemporal Dementia
  • Conditions studied: Frontotemporal dementia, Alzheimer’s disease; healthy volunteers are also included
  • Intervention Drugs: N/A.
  • Phase: Observational study.
  • Duration of participation: 3 year
  • IRB #: Pro00011837
  • IRB approval date:1/30/2015

Eligibility
Inclusion criteria: 

  • Patients: All enrolled patients will be between 30 and 90 (inclusive) years of age and have a diagnosis of FTD or AD. They must be fluent in English or Spanish and willing to undergo MRI 3 Tesla neuroimaging and PET scanning. All subjects must be willing and able to undergo all testing procedures, including MRI and PET.
  • Healthy volunteers:  All enrolled healthy volunteers will be between 30 and 90 (inclusive) years of age and cognitively intact. They must be fluent in English or Spanish and willing to undergo MRI 3 Tesla neuroimaging scanning. All subjects must be willing and able to undergo all testing procedures, including MRI.

Exclusion criteria: 

  • Include significant or unstable medical illness (e.g., poorly controlled diabetes, active cancer), clinically significant laboratory abnormalities on screening tests (e.g., thyroid function), contraindication to MRI including pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, and any contraindications to PET scanning, such as having reached the annual radiation dose prescribed by radiation safety guidelines and pregnancy.

What is involved?

  • Testing: Brain MRI, PIB PET scan, and for some (around 20) participants, two other optional PET scans (AV-1451 and PBR28) may be asked; arterial line placement, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, and blood specimen collection.
  • Frequency of visits: 4 visits (We will use around 13 hours of your time in the entire study)
  • Materials needed prior to evaluation: We will ask you to have a study partner who is willing to take part with you in this study. Your study partner is someone who knows you well and is willing to answer a 10-minute questionnaire, either in person or over the telephone, about your daily living skills.
  • Costs: No costs will be charged for any of the study procedures. Parking will be validated for all study visits. 

 

Top of page

 

 

 


 

 

Spinal Cord Inflammation in ALS

Amyotrophic lateral sclerosis (ALS) is currently an incurable disease with an average lifespan after diagnosis of about 6 years. People with ALS get worse in part because there is inflammation in the spinal cord. However, only now we have a procedure that could possibly allow doctors to measure inflammation in the spinal cord. This procedure is called a [11C]PBR28 positron emission tomography (PET) scan.
This study will allow us to determine whether or not this procedure can be used to measure inflammation in the spinal cord and compare it with the inflammation in the brain, measured also with PET. Measuring inflammation is very important as it will allow doctors to determine whether medications they are giving to reduce inflammation in ALS are working or not.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor: Houston Methodist Hospital Foundation
  • Recruiting?: Yes
  • Official study title: [11C]PBR28 PET to study microglial activation in amyotrophic lateral sclerosis spinal cord
  • Conditions studied: Amyotrophic lateral sclerosis; however, patients with Multiple Sclerosis and healthy volunteers will also be enrolled as control subjects.
  • Intervention Drugs: N/A.
  • Phase: Observational study
  • Duration of participation: The expected time you will be in this study is around 2 months.
  • IRB #: Pro00014287
  • IRB approval date: 4/1/2016

Eligibility
Inclusion criteria: 
Inclusion Criteria for ALS Subjects

  • Individuals of either sex, 18-75 years of age
  • Have sporadic or familial ALS
  • Have sufficient communication and comprehension ability to consent to the performance of the study
  • With a TSPO SNP genotype that allows at least partial binding of [11C]PBR28

Inclusion Criteria for Healthy Volunteers

  • Individuals of either sex, 18-75 years of age
  • Have enough communication and comprehension ability to consent to the performance of the study
  • With a TSPO SNP genotype that allows at least partial binding of [11C]PBR28

Inclusion Criteria for Controls with Multiple Sclerosis

  • Individuals of either sex, 18-75 years of age with the clinical or imaging diagnosis of spinal inflammatory lesions
  • Have enough communication and comprehension ability to consent to the performance of the study
  • With a TSPO SNP genotype that allows at least partial binding of [11C]PBR28

Exclusion criteria: 

Exclusion Criteria for ALS Subjects

  • Inability to undergo MRI or PET for any reason, including:
    • History of a cardiac pacemaker or pacemaker wires
    • Metallic particles in the body
    • Prosthetic heart valves
    • Claustrophobia
  • Being treated with steroids or large doses of other anti-inflammatory drugs
  • Presence of diaphragm pacing system (DPS)
  • The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease
  • Pregnancy or current breastfeeding

Exclusion Criteria for Healthy Volunteers

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • Being treated with steroids or large doses of other anti-inflammatory drugs
  • Substance abuse during the past two years
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease
  • Pregnancy

Exclusion Criteria for Controls with Multiple Sclerosis

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia
  • Active cancer, metabolic encephalopathy, infection, severe cardiovascular disease
  • Being treated with steroids or large doses of other anti-inflammatory drugs
  • Pregnancy

What is involved?

  • Testing: Spinal cord MRI and PBR PET scans, arterial line placement, EMGs, neurological and physical examinations including motor strength testing, blood specimen collection.
  • Frequency of visits: 4 visits
  • Costs: No costs will be charged for any of the study procedures. You will be compensated $100 for the PET scan and $100 for the MRI scan.  This will help pay for your time and any incidentals like parking and food.

 

Top of page

 

 

 


 

 

Tau imaging in acute mTBI

Persons who have suffered mild traumatic brain injury (mTBI) may experience cognitive problems and difficulties in interpersonal relationships. Some of these difficulties are caused by the brain disease itself, but doctors still do not understand well why this happens and therefore are limited in their ability to treat this problem.
Recent studies indicate that these problems could be associated with the deposition in the brain of an abnormal form of a protein called tau. In order to clarify this issue, we plan to study the brain accumulation of this protein in people with mTBI by means of a positron emission tomography (PET) scan, after the intravenous injection of a radioactive substance called AV1451.

  • Study director: Joseph C. Masdeu, MD, PhD
  • Sponsor:  Houston Methodist Hospital
  • Recruiting?: Yes
  • Official study title: [18F]AV‐145 PET to study ptau in vivo in the evolution of acute mTBI
  • Conditions studied: Mild traumatic brain injury (Concussion)
  • Intervention Drugs: N/A.
  • Phase: Observational study
  • Duration of participation: You will be expected to be in the study for about thirteen months, but will only have to come for 2, or, optionally, 3 visits.
  • IRB #: Pro00012451
  • IRB approval date: 4/13/2015

Eligibility
Inclusion criteria:
mTBI Patients

  • Individuals of either sex, 18-40 years of age.
  • Have sustained within the previous week an alteration in brain function caused by a process of sudden acceleration/deceleration of the brain.
  • The alteration of brain function is defined by having one or more of the following clinical signs:
  • Any period of loss of or a decreased level of consciousness (LOC)
  • Any loss of memory for events immediately before (retrograde amnesia) or after the injury (Post-Traumatic Amnesia, PTA)
  • Neurologic deficits (weakness, loss of balance, change in vision, dyspraxia paresis/plegia [paralysis], sensory loss, aphasia, etc.)
  • Any alteration in mental state at the time of the injury (confusion, disorientation, slowed thinking, etc.) not due to intoxication, medications, or multiple trauma to other body regions.
  • Fluent in English and have sufficient communication and comprehension ability to consent to the performance of the study.

Healthy volunteers

  • Individuals of either sex, 18-85 years of age.
  • Fluent in English and have enough communication and comprehension ability to consent to the performance of the study.

Patients with CTE , AD or FTD

  • Individuals of either sex, 30-85 years of age with the clinical diagnosis of CTE, AD, or FTD.
  • Fluent in English and have enough communication and comprehension ability to consent to the performance of the study.

Exclusion criteria: 
mTBI patients

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia.
  • Medications that interfere with the performance of [18F]AV-1451 PET.
  • Loss of consciousness longer than 30 min in connection with the traumatic event.
  • Post-traumatic amnesia lasting more than 24 hours after mTBI.
  • Glasgow Coma Scale scores lower than 13 after the mTBI.
  • History of previous moderate to severe TBI.
  • Brain disorder, other than an idiopathic headache, prior to mTBI.
  • Current primary Axis I or II psychiatric disorder.
  • Current use of psychotropic or anti-epileptic medication.
  • Substance abuse during the past two years.
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease.
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease.
  • Pregnancy.

Healthy volunteers

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia.
  • Medications that interfere with the performance of [18F]AV-1451 PET.
  • History of previous TBI of any kind.
  • Brain disorder, other than an idiopathic headache.
  • Current primary Axis I or II psychiatric disorder.
  • Current use of psychotropic or anti-epileptic medication.
  • Substance abuse during the past two years.
  • Active cancer, metabolic encephalopathy, infection, cardiovascular disease.
  • Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease.
  • Pregnancy.

Patients with CTE CTE, AD or FTD

  • Inability to undergo MRI or PET for any reason, including severe claustrophobia.
  • Active cancer, metabolic encephalopathy, infection, severe cardiovascular disease.
  • Pregnancy

What is involved?

  • Testing: History, Behavior, Neurological and neuropsychological examinations, an AV1451  PET scan.
  • Frequency of visits: Mainly 2 visits, and an optional 3rd visit.
  • Costs: The study will cover the cost of the clinical and neuropsychological examinations, as well as the PET scan. You will be paid $300 for taking part in the study. Parking passes will be validated.

 

Top of page

 

 

 


 

 

TRACK-ALS-001

The goal is to identify imaging biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project is tailored to produce imaging tools that will allow researchers to conduct future ALS clinical trials more efficiently.

  • Study directors: Nazem Atassi, MD, and Joseph C. Masdeu, MD, PhD
  • Sponsor: ALS Association and The Leandro P. Rizzuto Foundation
  • Recruiting?: Yes
  • Official study title: Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis (TRACK)
  • Conditions studied: Amyotrophic Lateral Sclerosis.
  • Intervention Drugs: N/A.
  • Phase: Observational study.
  • Duration of participation: If you choose to take part in this study there will be a total of 6 visits at Houston Methodist Hospital and telephone calls every 3 months.  You will be in this study for the rest of your life or until you decide you no longer want to participate.
  • IRB #: Pro00012428
  • IRB approval date: 2/9/2016

Eligibility
Inclusion criteria: 

  • Male or female, aged 18 to 80
  • Medically safe to undergo MRI scans
  • Able to safely lie supine for at least 90 minutes
  • Capable of providing informed consent and following trial procedures
  • Geographically accessible to the site

ALS subjects must meet the following criteria:

  • Possible, probable or definitely diagnosed sporadic or familial ALS

Those ALS subjects participating in the optional lumbar puncture portion of the study must meet the following criteria:

  • Subjects medically able to undergo lumbar puncture (LP) as determined by the investigator (i.e., no bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).

Exclusion criteria: 
Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:

  • Any contraindication to undergo MRI studies such as
  • History of a cardiac pacemaker or pacemaker wires
  • Metallic particles in the body / Vascular clips in the head
  • Prosthetic heart valves
  • Claustrophobia
  • Diagnosis of Parkinson’s disease or Alzheimer’s disease
  • Diagnosis of renal failure
  • Taking immunosuppressive medications such as steroids, cyclophosphamide, etc.
  • Presence of diaphragm pacing system (DPS)
  • The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent
  • Pregnant women or women currently breastfeeding
  • Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject’s full compliance with or completion of the study

What is involved?

  • Testing: Brain MRIs, lumbar punctures (optional), medical history, neurological and physical examinations, Vital capacity, cognitive testing, blood specimen collection, and  vital signs
  • Frequency of visits: A total of 6 visits at Houston Methodist Hospital and telephone calls every 3 months.
  • Costs: No costs will be charged for any of the study procedures. Subjects will be paid $100 for the baseline MRI scan and $100 for each optional follow-up MRI scans. Subjects will also be paid $200 for the optional lumbar puncture. Parking will be validated for all study visits.

 


For more information, please contact Clinical Research Coordinator Jennifer Garrett, RN, at 281.222.9983 or email jmgarrett@houstonmethodist.org

 

Top of page