18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study
Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Southern California
Collaborators:
Alzheimer's Association Alzheimer's Therapeutic Research Institute Avid Radiopharmaceuticals