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Initiate studies to develop minimally invasive biomarkers for detection of cerebral amyloidosis, AD and AD-related dementias pathophysiology.
2023 PAR-15-359: Novel Approaches to Diagnosing Alzheimer's Disease & Predicting Progression (R01) PAR-17-054: Leveraging Existing Cohort Studies to Clarify Risk and Protective Factors for Alzheimer’s Disease and Related Dementias (R01) RFA-AG-15-010: Interdisciplinary Research to Understand the Vascular Contributions to Alzheimer's Disease (R01) RFA-AG-15-011: Biomarkers of Alzheimer’s Disease in Down Syndrome (R01) RFA-AG-18-013: Continuation of the AMP AD Target Discovery and Preclinical Validation Consortium NOT-AG-18-019: Notice to Extend the Expiration Date for PAR-15-359 (re-issue of PAR-15-359) PAR-25-170: Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional) 9.F Achieved DN 2012 AD Summit: 1F and 1G News: NIH Supports new studies to find Alzheimer’s biomarkers in Down Syndrome News: Decoding the molecular ties between vascular disease and Alzheimer’s - NIH consortium uses big data, team science to uncover complex interplay of factors. News: Two views on Alzheimer's biomarkers: Eyeing changes in vision or pupils News: Retina study eyes Alzheimer’s processes to target for early screening News: Blood-brain barrier test may predict dementia News: Additional study points to potential promise of plasma NfL as a biomarker for familial Alzheimer’s disease
Development and testing of at least 3 biomarkers that utilize biofluids or other minimally invasive imaging, electrophysiological recording, or other methodologies to assess the burden of AD and ADRD pathophysiology that could be used in community based and epidemiological studies of AD and related dementias.
Summary of Key Accomplishments
NIA supports a growing portfolio of projects focused on discovering new diagnostic and prognostic fluid biomarkers for AD/ADRD. For example, NIH funded in FY23 the Centrally linked Longitudinal Peripheral Biomarkers of Alzheimer’s Disease in Multi-ethnic Populations (CLEAR-AD) Program, a multicenter research program seeking to identify the next generation of less expensive and less invasive fluid biomarkers of Alzheimer’s disease and related dementias in diverse populations.
Support from NIA was instrumental for the development of a robust test for measuring the ratio of two forms of amyloid beta in the blood — a key component of the PrecivityAD blood test developed by the NIH-funded biotech C2N. This is the first amyloid blood test to become available to some doctors, dependent on state-specific availability reflecting FDA guidelines. A second-generation version of this test, PrecivityAD2, incorporates measures of tau protein and was launched in August 2023.
Furthermore, NIH continues to support a wide variety of researchers to develop minimally invasive biomarkers. This includes funding from NIA programs for small biotech companies which are evaluating several new technologies. In addition to methods for analyzing a variety of molecular signatures collected in blood, NIA-supported small businesses are developing noninvasive methodologies that aim to detect AD/ADRD from ocular images, the brain’s electrical activity, and the contents of microscopic biological packages in the bloodstream.
In addition, NIA supports efforts focused on standardization and validation of peripheral fluid biomarkers through its participation in the FNIH Biomarker Consortium and by including these technologies across the NIA-supported AD Research Centers network.
The key accomplishments summary is current as of September 2025.