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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
50–85
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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
You may not be if
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)
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)
