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

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Key Information

Due Date: March 5, 2026


Agency: U.S. Department of Health and Human Services (HHS)


Source: Federal


Funding Category:

Health & Human Services

Funding Amount: Not Specified


Funding Type: Cooperative Agreement, Government


Match Required: No


Contact Info: grantsinfo@nih.gov
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

Overview

This grant opportunity, titled "Analytical and Clinical Validation of Biomarkers for Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional)" is aimed at advancing our understanding of effective and reliable biomarkers for Alzheimer's Disease and AD-Related Dementias. The aim of the grant is to speed up the usage of these biomarkers in discovering and developing medical products and treatments, as well as incorporate them in clinical trials and practices.

Specifically, the funding will support the analytical and clinical validation of a biomarker, which might be a composite biomarker or a biomarker signature. The process of validation should be carried out with a level of rigor matching the expectations described in the FDA's Biomarker Qualification Program (BQP) or as recommended by other FDA regulatory pathways. This grant represents an effort to enhance the effectiveness and reliability of therapeutic and diagnostic tools for those living with Alzheimer's disease and related dementias.

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Key Dates

Open Date: August 16, 2023


Application Due Date: March 5, 2026


Estimated Award Date: Not Specified

Additional Details

Eligible Activities

  • Research and Development

Eligible Applicants

  • State governments
  • County governments
  • City, village or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Private institutions of higher education
  • Small businesses

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