Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study
Public ClinicalTrials.gov record NCT02488720. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study. A Companion Observational Study to Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02488720
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 538 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 65 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 8, 2015 (Actual)
- Primary completion
- Sep 29, 2023 (Actual)
- Completion
- Sep 29, 2023 (Actual)
- Last update posted
- Nov 18, 2023
2015 – 2023
United States locations
- U.S. sites
- 40
- U.S. states
- 26
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | — |
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | — |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | — |
| University of California, Irvine | Irvine | California | 92697 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| VA Palo Alto HSC / Stanford School of Medicine | Palo Alto | California | 94304 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20057 | — |
| Howard University | Washington D.C. | District of Columbia | 20060 | — |
| Mayo Clinic, Jacksonville | Jacksonville | Florida | 32224 | — |
| Wien Center for Clinical Research | Miami Beach | Florida | 33140 | — |
| Synexus Clinical Research | Orlando | Florida | 32806 | — |
| University of South Florida - Health Byrd Alzheimer Institute | Tampa | Florida | 33613 | — |
| Synexus Clinical Research - The Villages | The Villages | Florida | 32162 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas | Fairway | Kansas | 66205 | — |
| University of Kentucky | Lexington | Kentucky | 40504 | — |
| Johns Hopkins University | Baltimore | Maryland | 21224 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Boston University | Boston | Massachusetts | 02118 | — |
| University of Michigan, Ann Arbor | Ann Arbor | Michigan | 48105 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| University of Rochester Medical Center | Rochester | New York | 14620 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Case Western Reserve University | Beachwood | Ohio | 44122 | — |
| Central States Research | Tulsa | Oklahoma | 74104 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-2676 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Butler Hospital Memory and Aging Program | Providence | Rhode Island | 02906 | — |
| Roper St. Francis Healthcare | Charleston | South Carolina | 29414 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02488720, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 18, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02488720 live on ClinicalTrials.gov.