Alzheimer's Disease
Conditions
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.
Interventions
DRUG[18F]GTP1
Participants will receive \[18F\]GTP1 as per the schedule specified in the arm description.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1 | From Baseline to 18 months |
Secondary
| 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 | 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 | From Baseline to 18 months |
| Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers | From Baseline to 18 months |
| Percentage of Participants With Adverse Events (AEs) | From Baseline to 18 months |
| Test-Retest Variability Based on [18F]GTP1 PET Scans | From date of test scan to 7-21 days after test scan |
Countries
United States
Outcome results
None listed