Expanding the Therapeutic Pipeline for Treating and Preventing Alzheimer’s Disease and Related Dementias: Preclinical Validation and Drug Discovery for Novel Candidate Targets (U01 Clinical Trial Not
Can you apply?
This grant is for research institutions and academic centers studying novel therapeutic targets for Alzheimer's disease and related dementias. Eligible applicants include research universities, independent research institutes, and health systems with strong research capabilities. The program funds preclinical validation and drug discovery work but explicitly excludes clinical trial phases. Applicants must have institutional capacity for translational research and access to appropriate laboratory facilities.
Key dates
- Mar 4, 2026 Applications open
- Oct 5, 2026 Application deadline in 126 days
- Jul 1, 2027 Award announced
- Jul 1, 2027 Project start
This grant is for research institutions and academic centers studying novel therapeutic targets for Alzheimer's disease and related dementias. Eligible applicants include research universities, independent research institutes, and health systems with strong research capabilities. The program funds preclinical validation and drug discovery work but explicitly excludes clinical trial phases. Applicants must have institutional capacity for translational research and access to appropriate laboratory facilities.
Program description
The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research on Alzheimer’s disease (AD) and AD-related dementias (ADRD) drug target validation and early-stage drug discovery against novel targets. This NOFO will utilize the U01 activity code. The NOFO will support rigorous preclinical AD/ADRD drug target validation and early-stage drug discovery of small molecules, biologic, and emerging therapeutic modalities. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise and insights into AD/ADRD and drug discovery are encouraged to begin to consider applying for this new NOFO.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for research institutions and academic centers studying novel therapeutic targets for Alzheimer's disease and related dementias. Eligible applicants include research universities, independent research institutes, and health systems with strong research capabilities. The program funds preclinical validation and drug discovery work but explicitly excludes clinical trial phases. Applicants must have institutional capacity for translational research and access to appropriate laboratory facilities.
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R)
- Project Narrative (Research Plan)
- Detailed Budget and Budget Justification
- Biographical Sketches (Key Personnel)
- Institutional Biosafety Committee Approval
- Letters of Institutional Support
- Preliminary Data and Publications
Program contact
- 👤 NIA Scientific Contact
- 📧 NIA-NOFO-Scientific@nih.gov
- 📞 Please contact via e-mail.
Funding track record
Recent awards under CFDA 93.866 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$463,372,200
-
$172,327,224
-
$115,145,694
-
$99,649,073
-
$93,275,174
-
$78,657,309
-
$75,825,492
-
$75,398,895
-
$70,985,470
-
$64,812,576
Top States by Funding
- MI 2 awards $511.9M
- CA 8 awards $511.1M
- MO 8 awards $437.0M
- IN 4 awards $303.9M
- PA 6 awards $298.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.866). How funding has trended year over year.
| 2024 | $3,746,886,731 | |
| 2025 | $3,777,464,644 | |
| 2026 est. | $261,814,471 |
FAQ
Who can apply for this grant?
Research institutions, universities, and independent research institutes with experience in translational neuroscience. Applicants must have institutional support and appropriate laboratory infrastructure.
What types of research are funded?
Preclinical validation and drug discovery for novel Alzheimer's targets. Clinical trials are not eligible under this mechanism.
What is the typical funding range?
U01 grants typically fund substantial projects with budgets ranging significantly. Check the RFP for specific cap information.
How competitive is this grant?
Very competitive. Only the strongest preclinical research with clear translational potential will be funded.
When is the deadline?
Check the NIH grants.gov website for the specific deadline. Applications opened March 4, 2026.
💡 Tips for applicants
- Focus on novelty of your target and strength of preliminary data supporting biological relevance.
- Emphasize your team's translational expertise and track record in moving targets toward therapeutic development.
- Provide detailed experimental plans with realistic timelines for each validation phase.
- Address intellectual property strategy and potential commercialization pathways early.
- Secure strong institutional biosafety and research compliance approvals before submission.
⚠️ Common mistakes
Applicants often overstate preliminary data or propose clinical endpoints that violate the preclinical-only requirement. Weak or underdeveloped preliminary data on target validation is frequently cited as a funding barrier. Failure to articulate a clear path from target discovery to drug lead identification undermines competitiveness.
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