Scout | PAR-25-209: Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional)

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grant PAR-25-209

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

Summary

This grant opportunity aims to support the validation of biomarkers—such as individual biomarkers, composites, or signatures—through analytical or clinical methods. The validation process should be rigorous and align with guidelines from the FDA's Biomarker Qualification Program or other FDA regulatory pathways.

Alzheimer’s disease (AD) and AD-related dementias (ADRD) are complex brain disorders that affect millions of Americans and are among the greatest healthcare challenges of the 21 st century. NIA , as the primary federal agency for AD research, supports research spanning from basic understanding o…

Funding Source

Agency: National Institutes of Health

Sub-agency: National Institute on Aging

Eligibility

Private Institutions of Higher Education

Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

For-Profit Organizations (Other than Small Businesses)

Independent School Districts

Native American Tribal Organizations (other than Federally recognized tribal governments)

Federal Government (Eligible Agencies of the Federal Government)

U.S. Territory or Possession

Public Housing Authorities/Indian Housing Authorities

Faith-based or Community-based Organizations

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Non-domestic (non-U.S.) components of U.S. Organizations

Foreign components are allowed as defined in the NIH Grants Policy Statement.
Required registrations (must be completed before submission; registration can take 6+ weeks and failure to register is not a valid reason for late submission): • System for Award Management (SAM) – Activ…

Dates

Opportunity Released: November 14, 2024

Open for Submission: November 14, 2024

Submission Deadline: March 5, 2026

Application Window Closes: March 5, 2026

Supporting links

National Institutes of Health

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