Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional)

The goal of this Notice of Funding Opportunity (NOFO) is to accelerate the establishment of effective and reliable biomarkers of Alzheimers disease (AD) and AD-related dementias (ADRD) for use in therapy/medical product discovery and development, clinical trials, and/or clinical practice. Specifically, this NOFO will support analytical and/or clinical validation of a biomarker, composite biomarker, or biomarker signature, with rigor comparable with the expectations described in the Food and Drug Administration (FDA) Biomarker Qualification Program (BQP) or recommended by other FDA regulatory pathways. Some key points to consider include: • The NOFO aims to support the development of biomarkers for AD and ADRD. • The funding opportunity will support analytical and/or clinical validation of biomarkers. • The application should demonstrate rigor comparable to the FDA's Biomarker Qualification Program. • The opportunity is open to various types of applicants, including non-profits, small businesses, and institutions of higher education. • The funding instrument for this opportunity is a Cooperative Agreement.