This grant, offered by the National Institutes of Health (NIH), aims to significantly advance the establishment of effective and reliable biomarkers for Alzheimer’s disease (AD) and AD-related dementias (ADRD). The primary objective is to accelerate the use of these biomarkers in critical areas such as therapeutic and medical product discovery and development, clinical trials, and ultimately, clinical practice. Specifically, this funding opportunity will support rigorous analytical and/or clinical validation of individual biomarkers, composite biomarkers, or biomarker signatures. All proposed validation activities must meet stringent scientific and regulatory standards, comparable to those expected by the Food and Drug Administration’s (FDA) Biomarker Qualification Program (BQP) or other relevant FDA regulatory guidelines. This initiative seeks to bolster the pipeline for new diagnostic and prognostic tools for these devastating conditions.
Opportunity ID: 357139
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-209 |
| Funding Opportunity Title: | Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.866 — Aging Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 15, 2024 |
| Last Updated Date: | Nov 15, 2024 |
| Original Closing Date for Applications: | Mar 05, 2026 |
| Current Closing Date for Applications: | Mar 05, 2026 |
| Archive Date: | Apr 10, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Private institutions of higher education State governments For profit organizations other than small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Special district governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments |
| Additional Information 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 |
| 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. |
| 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:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288734 | Jan 03, 2025 | Mar 05, 2026 | View |
Package 1
Mandatory forms
357139 RR_SF424_5_0-5.0.pdf
357139 PHS398_CoverPageSupplement_5_0-5.0.pdf
357139 RR_OtherProjectInfo_1_4-1.4.pdf
357139 PerformanceSite_4_0-4.0.pdf
357139 RR_KeyPersonExpanded_4_0-4.0.pdf
357139 PHS398_ResearchPlan_5_0-5.0.pdf
357139 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357139 RR_Budget_3_0-3.0.pdf
357139 RR_SubawardBudget30_3_0-3.0.pdf
357139 PHS398_ModularBudget_1_2-1.2.pdf
357139 PHS_AssignmentRequestForm_4_0-4.0.pdf
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