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

Completed · Phase 1

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02640092

Run by

Genentech, Inc.

People needed

72

Starts

2015-12-23

Expected to finish

2019-06-11

Last updated by the study team

2019-12-23

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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