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

Open

National Institutes of Health

Deadline: Mar 5, 2026federal

Updated: Oct 30, 2025

Summary

The purpose of this grant is to accelerate the establishment of effective biomarkers for Alzheimer's disease and related dementias, supporting their analytical and clinical validation in line with FDA standards. Eligible applicants include various government entities, for-profit and nonprofit organizations, educational institutions, and other specific groups such as tribal governments and historically black colleges. Application details are not specified, but interested parties can contact NIH Grants Information for further inquiries.

Full Description

Description

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.

Eligibility

Eligible applicants

Government

  • County governments
  • State governments
  • City or township governments
  • Special district governments
  • Public and Indian housing authorities
  • Federally recognized Native American tribal governments

Miscellaneous

  • Other

Business

  • For-profit organizations other than small businesses
  • Small businesses

Education

  • Independent school districts
  • Public and state institutions of higher education
  • Private institutions of higher education

Nonprofit

  • Nonprofits non-higher education with 501(c)(3)
  • Other Native American tribal organizations
  • Nonprofits non-higher education without 501(c)(3)

Additional information

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.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Apply on official siteUpdated Oct 30, 2025

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