Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled in the LEARN-Tau study. The study designed to evaluate the imaging characteristics of 18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database of 18F-AV-1451. The study will run in parallel to the LEARN study. In this study, participants will undergo up to four (4) 18F-AV-1451 PET scans over a 4.5 year period. Imaging visits will occur at the throughout the participant's participation in the LEARN study (corresponding to LEARN Visit 1, between Visit 4 and 6, Visit 8, and Visit 11). The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain over time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of older individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451 and any side effects that might be associated with it. Site investigators, participants, and study partners will not be informed of the results of the 18F-AV-1451 PET scan results as they relate to the study; however, any findings that may be of potential medical concern will be provided for appropriate follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
55
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Bioclinica Research North
The Villages, Florida, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Butler Hospital Memory and Aging Program
Providence, Rhode Island, United States
Rate of change of tau deposition as measured by 18F-AV-1451
Time frame: 3 years
Change in tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) from the baseline scan
Time frame: Baseline, 84 weeks, 168 weeks
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