Longitudinal Evaluation of Amyloid Risk and Neurodegeneration – the LEARN Study
About the Learn Study
The LEARN study was a multicenter, observational study that evaluated the rate of cognitive change in 540 clinically normal older individuals who “screen-failed” for the A4 trial. Meaning they did not meet enrollment criteria based on their PET imaging because they did not show evidence of elevated amyloid accumulation (Aβ negative). LEARN participants did meet all other A4 study eligibility criteria. This study leveraged the A4 infrastructure and maximized the data acquired in screening from a large number of well-characterized older adults for the A4 trial.
The LEARN observational cohort provides 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 15,000 well-characterized, highly motivated older volunteers “screen failed” for the A4 trial. The LEARN study followed 540 of these individuals, matched as closely as possible to the two treatment arms, in this observation cohort. The LEARN study selectively recruited 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 were 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 team lists
Longitudinal as of May 2023 — Journal Version
Screening as of August 2018 — Journal Version
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Access data from the study at a4studydata.org