Data from the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) study, the first and largest clinical trial of pre-symptomatic Alzheimer’s disease, is now available to researchers. This data has already provided important insights about Alzheimer’s disease, affecting nearly seven million people in the U.S., and sharing it opens new possibilities for progress.
A4 researchers screened over 7,500 people and enrolled 1,169 with pre-symptomatic Alzheimer’s disease. This stage, where amyloid protein starts to collect in the brain without cognitive decline, is ideal for intervention. They collected brain scans, blood samples, genetic info, and cognitive tests over 4.5 years, up to 8 years in the extension study.
“We tracked decline and learned a lot about this stage of the disease,” said Paul Aisen, MD, co-leader of the A4 study. “We want everyone to access this information and learn from it.”
This effort continues ATRI and the Keck School of Medicine’s priority to share data while protecting privacy. They also lead the clinical arm of the Alzheimer’s Disease Neuroimaging Initiative, a data sharing effort celebrating its 20th anniversary.
“This dataset shows our commitment to open science,” said Gustavo Jimenez-Maggiora, MBA, director of informatics at ATRI. “We share data to support and speed up further Alzheimer’s research discoveries.” The Epstein Family Foundation and matching donors made this data sharing possible.
The A4 study started in 2014 as a public-private partnership with the National Institute on Aging, Eli Lilly, the Alzheimer’s Association, GHR Foundation, and other groups. Researchers screened and selected 1,169 participants, aged 65 to 85, who showed amyloid buildup on PET scans but had no memory issues.
They collected extensive data, including PET and MRI scans, blood samples, genetic info, clinical details, and neuropsychological tests during monthly visits over 4.5 years.
They tested the drug solanezumab, which did not reduce amyloid or slow Alzheimer’s progression.
Aisen expects many data access requests after publicizing the A4 dataset at the Alzheimer’s Association International Conference.
They have also started the AHEAD3-45 Study to test the drug lecanemab for pre-symptomatic Alzheimer’s. Lecanemab was approved in 2023 by the FDA for later stages of the disease.
“We hope A4 and LEARN data will help future prevention trials to speed up efforts to prevent Alzheimer’s dementia,” said Reisa Sperling, MD, co-leader of the A4 study.
