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

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

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.

Source

Agency: National Institutes of Health

Sub-agency: National Institute on Aging

Dates

Opportunity Released: November 14, 2024

Open for Submission: November 14, 2024

Submission Deadline: March 5, 2026

Application Window Closes: March 5, 2026

Eligibility

university

nonprofit

small_business

tribal

government

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

Keywords

Biomarkers

Alzheimer's Disease

Dementias

Clinical Validation

Analytical Validation

FDA

Biomarker Qualification Program

Composite Biomarker

Biomarker Signature

Regulatory Pathways

Supporting Links

Documents

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