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

December 19, 2019 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1
Time Frame: From Baseline to 18 months
From Baseline to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13
Time Frame: From Baseline to 18 months
From Baseline to 18 months
Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures
Time Frame: From Baseline to 18 months
From Baseline to 18 months
Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers
Time Frame: From Baseline to 18 months
From Baseline to 18 months
Percentage of Participants With Adverse Events (AEs)
Time Frame: From Baseline to 18 months
From Baseline to 18 months
Test-Retest Variability Based on [18F]GTP1 PET Scans
Time Frame: From date of test scan to 7-21 days after test scan
From date of test scan to 7-21 days after test scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2015

Primary Completion (Actual)

June 11, 2019

Study Completion (Actual)

June 11, 2019

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on [18F]GTP1

3
Subscribe