This grant, offered by a leading department, targets the preclinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates for Alzheimer’s disease (AD). Its core purpose is to advance therapies that prevent AD, slow its progression, or alleviate cognitive and behavioral symptoms. Funding supports critical activities including medicinal chemistry, pharmacokinetics, ADMET, efficacy testing in animal models, biomarker development for target engagement, formulation, GMP synthesis, Investigational New Drug (IND) enabling studies, and initial Phase I clinical trials. This program prioritizes direct drug development over basic research, certain biomarker types, non-pharmacological interventions, or repurposed drugs, focusing specifically on novel therapeutic agents.
Opportunity ID: 357529
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-297 |
| Funding Opportunity Title: | Alzheimer’s Drug-Development Program (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: | Dec 04, 2024 |
| Last Updated Date: | Dec 04, 2024 |
| Original Closing Date for Applications: | Nov 05, 2027 |
| Current Closing Date for Applications: | Nov 05, 2027 |
| Archive Date: | Dec 11, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses City or township governments Special district governments For profit organizations other than small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education |
| 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer’s disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-297.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
Folder 357529 Full Announcement-PAR-25-297 -> PAR-25-297-Full-Announcement.pdf
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 | PKG00289419 | Jan 03, 2025 | Nov 05, 2027 | View |
Package 1
Mandatory forms
357529 RR_SF424_5_0-5.0.pdf
357529 PHS398_CoverPageSupplement_5_0-5.0.pdf
357529 RR_OtherProjectInfo_1_4-1.4.pdf
357529 PerformanceSite_4_0-4.0.pdf
357529 RR_KeyPersonExpanded_4_0-4.0.pdf
357529 PHS398_ResearchPlan_5_0-5.0.pdf
357529 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357529 RR_Budget_3_0-3.0.pdf
357529 RR_SubawardBudget30_3_0-3.0.pdf
357529 PHS398_ModularBudget_1_2-1.2.pdf
357529 PHS_AssignmentRequestForm_4_0-4.0.pdf
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