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

November 14, 2023 updated by: Paul Aisen, University of Southern California

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • The Villages, Florida, United States, 32162
        • Bioclinica Research North
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital Memory and Aging Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Exclusion Criteria:

  • Has any condition that, in the investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with analysis of the data. (For example, participants with chronic back pain might not be able to lie still during the scanning procedures.);
  • Has abnormal findings on physical examination or laboratory screening tests that suggest the participant might have a condition that could, in the opinion of the investigator, affect his or her response to the radiopharmaceutical and related testing procedures;
  • Is deemed likely to be unable to perform all of the imaging procedures for any reason;
  • Has a history of risk factors for torsades de pointes, including clinically significant findings on ECG, or is taking medications known to prolong QT interval such as citalopram ≥ 40 mg/day, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, or bepridil; A list of restricted medications will be provided.
  • Are females of childbearing potential (extremely unlikely in the LEARN eligible population ages 65 to 85) who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum or urine β-hCG at the time of screening and negative serum or urine β-hCG on imaging day) or breastfeeding at screening. Females must agree to avoid becoming pregnant, and both females and males must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of 18F-AV-1451 Injection; Males with female partners who are pregnant or of childbearing potential must agree to refrain from sexual activity for 24 hours following administration of 18F-AV-1451 Injection. Additionally, males must agree not to donate sperm for 24 hours following administration of 18F-AV-1451 Injection;
  • Has hypersensitivity to 18F-AV-1451 or any of its excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-AV-1451
50 individuals who are cognitively normal, older, Aβ not elevated and enrolled in the LEARN study will undergo 18F-AV-1451 imaging procedures at 4 time points over a 4.5 year period.
Drug: 18F-AV-1451

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of change of tau deposition as measured by 18F-AV-1451
Time Frame: 3 years
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
Baseline, 84 weeks, 168 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Avid Radiopharmaceuticals
Alzheimer's Therapeutic Research Institute
Alzheimer's Association

Investigators

  • Study Director: Reisa Sperling, MD, Center for Alzheimer Research and Treatment Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimated)

July 29, 2016

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-1451-A17
  • 15-338729 (Other Grant/Funding Number: Alzheimer's Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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