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.
Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial 2
The API ADAD Colombia Trial Program (Clinicaltrials.gov NCT06996730) is a new clinical trial that will test the efficacy (as measured by amyloid PET) of the anti-amyloid antibody, donanemab, in autosomal dominant Alzheimer’s disease (ADAD) in the Colombian PSEN1E280A kindred, the world’s largest extended family with ADAD. The study will also explore various ways to maintain low brain amyloid levels using donanemab, a novel gamma secretase modulator, RG6289, or the combination of the two drugs.
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.
eSMARTER
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 overaching grant supporting eSMARTER and its ancillary studies will provide the foundation for the next stage of prevention trials – primary prevention studies.
Draw-10
Draw-10 is an observational research study exploring fluctuations in blood biomarkers over a short period and potential associated drivers of these fluctuations.
eDROP-AD
eDROP-AD aims to address existing challenges in accessibility and scalability of AD biomarker testing by assessing the usability, tolerability, and acceptability of capillary (via finger prick) blood sample using blood collection cards.
Additional prevention trials to come.