CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 55 enrolled
Drug / intervention
18F-AV-1451drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02850146
NCT02850146Phase 1Completed

18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study

University of Southern California·interventional·Posted Jul 29, 2016·Updated Nov 18, 2023

In Brief

A Phase 1 clinical trial evaluating 18F-AV-1451 for Cognition Disorders. Completed, enrolled 55 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 29, 2016
Enrollment StartAug 1, 2016
Primary CompletionSep 29, 2023
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 9.9 years ago

Interventions

18F-AV-1451drug