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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
72
Participants will receive \[18F\]GTP1 as per the schedule specified in the arm description.
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
...and 6 more locations
Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1
Time frame: From Baseline to 18 months
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
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
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
Percentage of Participants With Adverse Events (AEs)
Time frame: 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
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