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Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02640092
Collaborator
(none)
72
Enrollment
16
Locations
1
Arm
41.6
Actual Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, longitudinal observational study evaluating the imaging characteristics of the tau positron-emission tomography (PET) radioligand [18F] Genentech Tau Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's disease (AD) compared to healthy participants. The overall goal of this protocol is to evaluate the longitudinal change in tau burden using [18F]GTP1, a tau targeted radiopharmaceutical.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Patients With Prodromal, Mild, and Moderate Alzheimer's Disease Compared to Healthy Volunteers
Actual Study Start Date :
Dec 23, 2015
Actual Primary Completion Date :
Jun 11, 2019
Actual Study Completion Date :
Jun 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: [18F]GTP1

Participants will complete [18F]GTP1 PET imaging at four time points: Baseline, 6 months, 12 months and 18 months. For each [18F]GTP1 imaging session, the following procedure will be performed: a catheter will be placed for intravenous (IV) administration of [18F]GTP1. Participants will receive an IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]) of [18F]GTP1.

Drug: [18F]GTP1
Participants will receive [18F]GTP1 as per the schedule specified in the arm description.
Other Names:
  • [18F]G02941054
  • [18F]MNI-798
  • [18F]RO6880276

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1 [From Baseline to 18 months]

    Secondary Outcome Measures

    1. Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13 [From Baseline to 18 months]

    2. Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures [From Baseline to 18 months]

    3. Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers [From Baseline to 18 months]

    4. Percentage of Participants With Adverse Events (AEs) [From Baseline to 18 months]

    5. Test-Retest Variability Based on [18F]GTP1 PET Scans [From date of test scan to 7-21 days after test scan]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    For All Participants:
    • Availability of a study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to accompany the participant and provide information at visits
    For Healthy Participants:

    • Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline [18F]GTP1 imaging visit

    • Have no cognitive complaint

    • Have a Clinical Dementia Rating Scale (CDR) global score = 0

    • Have a Mini-Mental State Examination (MMSE) score of 28-30

    For Participants With a Diagnosis of AD:

    • Participants with mild or moderate AD must meet National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia, with an amnestic presentation

    • Participants with prodromal AD must meet NIA-AA core clinical criteria for mild cognitive impairment (MCI)

    • Have screening [18F]florbetapir PET imaging demonstrating amyloid binding based on qualitative visual read

    • A brain MRI consistent with a diagnosis of AD, with no evidence of non-AD disease to account for dementia or MRI exclusion criteria

    • Medications taken for symptomatic treatment of AD must remain stable for at least 30 days prior to screening visit

    • Satisfy one of the following subgroups: Approximately 20 prodromal AD (MMSE 24-30, CDR = 0.5); Approximately 20 mild AD (MMSE 22-30, CDR = 0.5 or 1); Approximately 20 moderate AD (MMSE 16-21, CDR = 0.5 or 1 or 2)

    Exclusion Criteria:

    • Current or prior history of any drug or alcohol abuse

    • Participants with any significant psychiatric, neurological, or unstable medical disorder expected to interfere with the study

    • Participants unable to undergo MRI and PET scan

    • For participants contributing CSF samples, any contraindication to lumbar puncture

    • Prior participation in other research protocols or clinical care in the last year such a radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSV), the allowable annual limit for research participants as stipulated by the Food and Drug Administration (FDA)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Molecular NeuroImaging New Haven Connecticut United States 06510
    2 KI Health Partners, LLC; New England Institute for Clinical Research Stamford Connecticut United States 06905
    3 Neuropsychiatric Research; Center of Southwest Florida Fort Myers Florida United States 33912
    4 Miami Jewish Health Systems Miami Florida United States 33137
    5 Bioclinica Research Orlando Florida United States 32806
    6 Emory University Atlanta Georgia United States 30303
    7 NeuroStudies.net, LLC Decatur Georgia United States 30033
    8 Acadia Clinical Research; Dr. Henderson's Office Bangor Maine United States 04401
    9 Donald S. Marks, M.D., P.C.; Medical Center Plymouth Massachusetts United States 02360
    10 Alzheimers Disease Center Quincy Massachusetts United States 02169
    11 NeuroCognitive Institute Mount Arlington New Jersey United States 07856
    12 Bio Behavioral Health Toms River New Jersey United States 08755
    13 Advanced Medical Research Maumee Ohio United States 43537
    14 Lehigh Center Clinical Research Allentown Pennsylvania United States 18104
    15 Rhode Island Mood & Memory Research Institute East Providence Rhode Island United States 02914
    16 Butler Hospital Providence Rhode Island United States 02906

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT02640092
    Other Study ID Numbers:
    • GN30009
    • G0097
    First Posted:
    Dec 28, 2015
    Last Update Posted:
    Dec 23, 2019
    Last Verified:
    Dec 1, 2019
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Dec 23, 2019