Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional)
Accelerating validation of biomarkers for Alzheimer's Disease and related dementias to improve therapy development and clinical practice.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: January 3, 2025 (Letter of Intent) | February 5, 2025 (New) | March 5, 2025 (Renewal/Resubmission/Revision) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | February 5, 2026 (New) | March 5, 2026 (Renewal/Resubmission/Revision)
Funding Amounts: No budget limit; up to 5 years for analytical+clinical or clinical validation, 4 years for analytical only; budgets must reflect actual project needs.
Summary: Supports rigorous analytical and/or clinical validation of biomarkers for Alzheimer's disease and related dementias to accelerate their use in therapy development, clinical trials, and clinical practice.
Key Information: Clinical trial optional; non-domestic (non-U.S.) entities are eligible; projects proposing biomarker discovery or non-human studies are not responsive.
Description
This opportunity from the National Institutes of Health (NIH), led by the National Institute on Aging (NIA), aims to accelerate the establishment of effective and reliable biomarkers for Alzheimer's disease (AD) and AD-related dementias (ADRD). The focus is on supporting the analytical and/or clinical validation of candidate biomarkers, composite biomarkers, or biomarker signatures, with rigor comparable to the standards set by the FDA's Biomarker Qualification Program (BQP) or other FDA regulatory pathways.
The program uses the U01 cooperative agreement mechanism, which involves substantial NIH programmatic involvement and milestone-driven project management. Projects may address analytical validation, clinical validation, or both, depending on the current stage of biomarker development.
