Alzheimer’s Drug-Development Program (U01 Clinical Trial Optional)
Can you apply?
This grant is for researchers and research institutions conducting clinical trials and drug development work focused on Alzheimer's disease and related dementias. Eligible applicants typically include academic medical centers, research universities, nonprofit research organizations, and biotech/pharmaceutical companies with 501(c)(3) status or equivalent research designation. The program supports domestic and international collaborative research, with preference for NIH-designated Minority-Serving Institutions and HBCUs. Both individual researchers (with appropriate institutional affiliation) and established research teams may apply. Funding supports the full spectrum of Alzheimer's drug development from preclinical work through Phase III clinical trials, including biomarker research, mechanism studies, and therapeutic validation.
This grant is for researchers and research institutions conducting clinical trials and drug development work focused on Alzheimer's disease and related dementias. Eligible applicants typically include academic medical centers, research universities, nonprofit research organizations, and biotech/pharmaceutical companies with 501(c)(3) status or equivalent research designation. The program supports domestic and international collaborative research, with preference for NIH-designated Minority-Serving Institutions and HBCUs. Both individual researchers (with appropriate institutional affiliation) and established research teams may apply. Funding supports the full spectrum of Alzheimer's drug development from preclinical work through Phase III clinical trials, including biomarker research, mechanism studies, and therapeutic validation.
Program 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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- 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 researchers and research institutions conducting clinical trials and drug development work focused on Alzheimer's disease and related dementias. Eligible applicants typically include academic medical centers, research universities, nonprofit research organizations, and biotech/pharmaceutical companies with 501(c)(3) status or equivalent research designation. The program supports domestic and international collaborative research, with preference for NIH-designated Minority-Serving Institutions and HBCUs. Both individual researchers (with appropriate institutional affiliation) and established research teams may apply. Funding supports the full spectrum of Alzheimer's drug development from preclinical work through Phase III clinical trials, including biomarker research, mechanism studies, and therapeutic validation.
How to apply
Application links
Required documents
- NIH Form SF-424 R&R (Application for Federal Assistance) with all required certifications
- Project Narrative (typically 15 pages maximum) describing specific aims, significance, innovation, and approach
- Detailed Project Budget and Budget Justification (Form PHS 398 or equivalent)
- Biosketch for all key personnel (NIH format, 3-5 pages each)
- Vertebrate animals section (if applicable) with IACUC approval documentation
- Human subjects protection documentation and IRB approval (if applicable to clinical trials)
- Letters of support from collaborating institutions and clinical trial sites
- Resource sharing plan and data management plan
- Conflict of interest disclosures (financial and programmatic)
- Institutional commitment letter demonstrating resources available for the project
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
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
What types of institutions can apply for this grant?
Research universities, academic medical centers, nonprofit research organizations, for-profit companies with appropriate research credentials, and other research entities can apply. Applicants must have an active Dun & Bradstreet Data Universal Numbering System (DUNS) number and be registered with the System for Award Management (SAM).
What are the key deadlines I should know about?
The application opens December 4, 2024, with a fixed deadline of November 5, 2027. This is a typical NIH timeline allowing substantial preparation time. Check the NIH grant website for any additional submission windows or rolling deadlines.
What research activities does this program fund?
The program funds Alzheimer's drug development including preclinical research, biomarker discovery, mechanism of action studies, IND-enabling studies, and clinical trials (Phase I-III). Optional clinical trial components allow flexibility for different research stages.
How competitive is this funding opportunity?
U01 grants are moderately to highly competitive. Success typically requires strong preliminary data, experienced research teams, clear therapeutic rationale, and demonstrated institutional commitment. Most funded applications show prior NIH funding history and strong publication records.
What is the typical funding range?
NIH U01 grants typically range from $350,000 to $500,000 per year (total costs), though amounts vary by project complexity and multi-institutional collaborations. Budget justification must align with specific aims and milestones.
💡 Tips for applicants
- Build a compelling preliminary data package showing proof-of-concept for your therapeutic approach; weak preliminary data is a major reason for rejection in this mechanism.
- Clearly articulate your drug development strategy with realistic timelines from current stage through clinical trial readiness; vague or over-ambitious plans will hurt competitiveness.
- Address potential safety and efficacy concerns head-on in your application rather than downplaying them; reviewers expect thoughtful consideration of risk mitigation.
- Establish strong team composition with complementary expertise in neurobiology, pharmacology, clinical trial design, and biostatistics; gaps in expertise are commonly flagged by reviewers.
- Include letters of support from clinical trial sites and regulatory consultants if you're proposing clinical work; this demonstrates feasibility and reduces perceived institutional risk.
⚠️ Common mistakes
Many applications fail due to insufficient or unconvincing preliminary data; reviewers need robust evidence that the therapeutic approach is scientifically sound before committing to multi-year funding. Additionally, overly complex or poorly justified drug development timelines that don't account for regulatory requirements or realistic preclinical-to-clinical transitions frequently result in unfavorable reviews. Finally, inadequate team composition or missing key expertise in translational pharmacology, clinical trial management, or biomarker validation weakens competitiveness significantly.
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