Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional) (PAR-23-258)

This notice of funding opportunity (NOFO) invites applications to accelerate the establishment of effective and reliable biomarkers of Alzheimer’s 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 to the expectations described in the Food and Drug Administration (FDA's) Biomarker Qualification Program (BQP) or recommended by other FDA regulatory pathways.