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

National Institutes of Health

About this archived opportunity

The goal of this Notice of Funding Opportunity (NOFO) is to accelerate the establishment ofeffective and reliable biomarkers of Alzheimers disease (AD) and AD-related dementias (ADRD) for usein therapy/medical product discovery and development, clinical trials and/or clinical practice. Specifically, this NOFO willsupport analytical and/or clinical validationof a biomarker, composite biomarker or biomarker signature, withrigor comparable with the expectations described in the Food and Drug Administration (FDA)Biomarker Qualification Program (BQP) or recommended by other FDA regulatory pathways.

Historical details

Status
Closed
Deadline
March 5, 2026
First captured
December 17, 2025
Publisher reference
357139

Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

This opportunity has closed

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

by National Institutes of Health

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