Alzheimer’s disease (AD) is one of the biggest health challenges of our time, and, unfortunately, for decades we witnessed the failure of hundreds of clinical trials in this area. The FNIH has been leading major public-private partnerships to tackle this complex biomedical problem by accelerating our understanding of Alzheimer’s disease and helping to expedite the development of effective treatments.

The landmark Alzheimer’s Disease Neuroimaging Initiative (ADNI) was established in 2004 by the National Institute on Aging and managed by the FNIH for nearly two decades. ADNI’s primary objective was to collect, analyze, and share comprehensive data on Alzheimer’s disease.

Pathway to Impact:

• Its impact on brain research has been monumental. ADNI developed and validated biomarkers to change the way clinical trials are designed and executed, ultimately improving success rates in Alzheimer’s clinical trials investigating new therapies. A biomarker is a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention.
• ADNI researchers discovered and validated multiple neuroimaging and biofluid biomarkers, including the presence of amyloid plaques in the brain. This work paved the way for FDA approvals of the first disease-modifying drugs to help slow the course of AD, including Leqembi, which was shown to reduce amyloid plaques and slow declines in memory and thinking.
• It was the first time that government organizations, pharmaceutical companies, and nonprofits collaborated on Alzheimer’s research. Moreover, ADNI established a model for public-private research collaborations that led to other FNIH projects focused on Alzheimer’s disease.
  • The Accelerating Medicines Partnership^® (AMP^®) for Alzheimer’s Disease has established a pre-competitive research portal that provides open access to large-scale genomic and other molecular data related to Alzheimer’s. The second iteration of AMP Alzheimer’s Disease is expanding the diversity of biosamples in the portal and supporting new technologies to enable a precision medicine approach to therapy development.
  • The FNIH Biomarkers Consortium convenes cross-sector partners from government, industry, patient advocacy groups, and advocacy organizations to validate and qualify biomarkers and other drug development tools to accelerate better decision making for the development of new therapeutics and health technologies. We are currently evaluating and comparing the top performing Ab and phosphorylated tau (pTau) assays to determine which have the highest degree of correlation with amyloid positivity in Alzheimer’s disease.