The National Institutes of Health (NIH) is offering this grant to streamline early-stage clinical drug development (Phase 1 to 2a) for novel therapeutic agents targeting Alzheimer’s disease (AD) and AD-related Dementias (ADRD). This grant is for researchers seeking to evaluate promising pharmacological interventions, including small molecules or biologics, that engage non-amyloid/non-tau mechanisms. The primary purpose is to address cognitive and/or neuropsychiatric symptoms across the full spectrum of disease stages, from pre-symptomatic to severe. Applications should bundle Phase 1 and Phase 1b/2a protocols, utilizing the UG3/UH3 phased award mechanism. Crucially, proposals must incorporate clear go/no-go safety and tolerability milestones to gate progression between trial phases, ensuring efficient and safe advancement of new AD/ADRD therapies.
Opportunity ID: 357343
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-226 |
| Funding Opportunity Title: | Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer’s Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 22, 2024 |
| Last Updated Date: | Nov 22, 2024 |
| Original Closing Date for Applications: | Nov 19, 2026 |
| Current Closing Date for Applications: | Nov 19, 2026 |
| Archive Date: | Dec 25, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Public and State controlled institutions of higher education State governments Native American tribal governments (Federally recognized) 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 County governments City or township governments Private institutions of higher education Small businesses |
| 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 purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer’s disease (AD) and Alzheimer’s disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics for example, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to latter stages of clinical development. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-226.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 357343 Full Announcement-PAR-25-226 -> PAR-25-226-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 | PKG00288961 | Jan 21, 2025 | Nov 19, 2026 | View |
Package 1
Mandatory forms
357343 RR_SF424_5_0-5.0.pdf
357343 PHS398_CoverPageSupplement_5_0-5.0.pdf
357343 RR_OtherProjectInfo_1_4-1.4.pdf
357343 PerformanceSite_4_0-4.0.pdf
357343 RR_KeyPersonExpanded_4_0-4.0.pdf
357343 RR_Budget10_3_0-3.0.pdf
357343 PHS398_ResearchPlan_5_0-5.0.pdf
357343 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357343 RR_SubawardBudget10_30_3_0-3.0.pdf
357343 PHS_AssignmentRequestForm_4_0-4.0.pdf
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