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Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study
NCT02488720 · View on ClinicalTrials.gov ↗
Study Summary
The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria. This study will leverage the A4 infrastructure and maximize the data acquired in screening a large number of well-characterized older adults for the A4 trial. The LEARN observational cohort will provide a critical comparison group for the A4 placebo arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it is important to demonstrate a differential rate of clinical decline between Aβe ("Aβ elevated") and Aβne ("Aβ not elevated") individuals on a standardized set of clinical outcomes. Over 2000 well-characterized, highly motivated older volunteers will "screen fail" for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as possible to the two treatment arms, in this observation cohort. The LEARN study may selectively recruit from a specific range of SUVr that fall below the threshold for "elevated amyloid" in order to support analyses of the relationship of baseline SUVr to subsequent cognitive change and amyloid accumulation. The observational cohort will be followed for 384 weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to the A4 treatment study and open label extension.
Conditions Studied
Study Locations (20)
Florida
- Mayo Clinic, Jacksonville — Jacksonville
- Wien Center for Clinical Research — Miami Beach
- Synexus Clinical Research — Orlando
- University of South Florida - Health Byrd Alzheimer Institute — Tampa
- Synexus Clinical Research - The Villages — The Villages
California
- University of California, Irvine — Irvine
- University of Southern California — Los Angeles
- University of California, Los Angeles — Los Angeles
- VA Palo Alto HSC / Stanford School of Medicine — Palo Alto
Arizona
- Banner Alzheimer's Institute — Phoenix
- Banner Sun Health Research Institute — Sun City
District of Columbia
- Georgetown University — Washington D.C.
- Howard University — Washington D.C.
Illinois
- Northwestern University — Chicago
- Rush University Medical Center — Chicago
Alabama
- University of Alabama, Birmingham — Birmingham
Connecticut
- Yale University School of Medicine — New Haven
Georgia
- Emory University — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 538 participants |
| Start Date | 2015-09-08 |
| Est. Completion | 2023-09-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02488720
The ClinicalTrials.gov registry entry for NCT02488720 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 538 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cognition Disorders appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02488720 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02488720 about?
NCT02488720 is a clinical study titled "Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study". The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of elevated amyloid accumulation ...
What is the current status of trial NCT02488720?
This trial is currently completed. The enrollment target is 538 participants. The study started on 2015-09-08. Estimated completion is 2023-09-29.
What conditions does trial NCT02488720 study?
This clinical trial studies the following conditions: Cognition Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02488720?
This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02488720 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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