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Alzheimer’s Prevention Initiative Studies

The Alzheimer’s Prevention Initiative (API) has introduced groundbreaking research paradigms, cognitive and biomarker assessment tools, and Alzheimer’s prevention trials.

We launched the first-ever NIH-funded trial of a potential disease-modifying therapy for cognitively unimpaired adults at virtually certain risk of developing early onset Alzheimer’s dementia due to a genetic mutation specific to a cohort of families in Colombia, South America.

This trial, known as the API ADAD Colombia Trial, triggered a growing number of prevention trials, several of which have been co-led by API with partners from academia and industry.

Studies include:

Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial

The API Autosomal Dominant Alzheimer’s Disease (ADAD) Colombia Trial, which studied the use of an anti-amyloid treatment, crenezumab, in cognitively unimpaired PSEN1 E280A mutation carriers and non-carriers from the world’s largest ADAD kindred (clinicaltrials.gov NCT01998841). Mutation carriers are at virtually certain risk for developing Alzheimer’s dementia at younger ages. The study was led by Banner Alzheimer’s Institute, the University of Antioquia in Colombia, Genentech, and its parent organization Roche.

Generation Program

The API Generation Program was made up of two clinical trials – Generation Study 1 and Generation Study 2 – and examined two investigational study medications, CAD106 and umibecestat, in cognitively unimpaired adults with one or two copies of the APOE4 gene, putting them at particularly high risk for developing Alzheimer’s dementia in later life (clinicaltrials.gov NCT02565511 and NCT03131453). These international studies were part of a collaboration between BAI, Novartis, and Amgen.

API/A4 Program

The API/A4 Program is studying cognitively unimpaired adults at risk for developing Alzheimer’s dementia in later life. eSMARTER is a randomized trial seeking to evaluate self-directed scalable eHealth methods for communicating Alzheimer’s gene and biomarker results, as well as characterize the clinical impacts of learning this information on the participant. Data from the API/A4 program will provide the foundation for the next stage of prevention trials – primary prevention studies. The API/A4 program is led by Banner Alzheimer’s Institute, Brigham and Women’s Hospital, Harvard Medical School, and the Alzheimer’s Therapeutic Research Institute (ATRI) at the Keck School of Medicine of USC.

TRAILBLAZER-ALZ3

Eli Lilly and Banner Alzheimer’s Institute formed a strategic research collaboration as part of the TRAILBLAZER-ALZ 3 program. TRAILBLAZER-ALZ 3 is evaluating whether treatment with donanemab can slow the progression of Alzheimer’s disease. This randomized, double-blind, placebo-controlled trial enrolled cognitively unimpaired participants age 65-80 years of age with a blood test (p-tau) result consistent with the presence of amyloid and early-tau pathology. The TRAILBLAZER-ALZ 3 introduced a more virtual approach to the evaluation of Alzheimer’s prevention therapies by including “decentralized” trial sites and allowing participants and their study partners to complete many study procedures from home.

Additional prevention trials to come.