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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

PAR-25-209

HHS-NIH11

General Information

N/a
Est. Program Funding:
March 5, 2026
Closing Date:
N/a
Expected No. of Awards
N/a
Award Ceiling

Opportunity Number:
PAR-25-209

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

Synopsis

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.
Response Date Mar 05, 2026 12:00:00 AM EST
Posting Date Nov 14, 2024 12:00:00 AM EST
Archive Date Apr 10, 2026 12:00:00 AM EDT
Award Ceiling N/a
Award Floor N/a
Cost Sharing No

Eligibility

Eligible Applicants Public housing authorities/Indian housing authorities, County governments, Public and State controlled institutions of higher education, Independent school districts, Private institutions of higher education, State governments, Native American tribal governments (Federally recognized), Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), City or township governments, Special district governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, For profit organizations other than small businesses, Small businesses, Native American tribal organizations (other than Federally recognized tribal governments)
Additional Info on 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.

Additional Information

Agency Name National Institutes of Health
Link to Additional Information: https://grants.nih.gov/grants/guide/pa-files/PAR-25-209.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk
Phone: 301-402-2541

CFDA Program(s)

  • 93.866: Aging Research
   

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