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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02850146

Acronym

LEARN-Tau

Enrollment

Registered

2016-07-29

Start date

2016-08-31

Completion date

2023-09-29

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorders

Keywords

tau, cognition, longitudinal, cognitive decline, observational, imaging

Brief 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.

Interventions

DRUG18F-AV-1451

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Participants should meet inclusion and

Exclusion criteria

for the LEARN study, and in addition: Inclusion Criteria: * Male or female that have consented and are currently enrolled in the LEARN protocol; * Participants who sign an IRB approved informed consent form prior to any study procedure; and * Participants who in the opinion of the investigator can tolerate the PET scan procedures.

Design outcomes

Primary

Measure	Time frame
Rate of change of tau deposition as measured by 18F-AV-1451	3 years
Change in tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) from the baseline scan	Baseline, 84 weeks, 168 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026