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 Require
Can you apply?
This grant is for academic research institutions, pharmaceutical companies, and biotech organizations advancing novel therapeutics through early-stage clinical development for Alzheimer's Disease and related dementias. The UG3/UH3 mechanism supports the seamless transition from Phase 1 to Phase 2a clinical trials, making it appropriate for organizations with established clinical research capabilities and regulatory expertise. Applicants must demonstrate preliminary preclinical or clinical data supporting the therapeutic approach, access to appropriate patient populations, and institutional capacity to conduct rigorous clinical trials. Geographic scope is primarily U.S.-based organizations, though international collaborators may participate. The grant supports drug development activities including clinical protocol development, regulatory navigation, trial execution, and biomarker assessment specific to AD/ADRD therapeutics.
This grant is for academic research institutions, pharmaceutical companies, and biotech organizations advancing novel therapeutics through early-stage clinical development for Alzheimer's Disease and related dementias. The UG3/UH3 mechanism supports the seamless transition from Phase 1 to Phase 2a clinical trials, making it appropriate for organizations with established clinical research capabilities and regulatory expertise. Applicants must demonstrate preliminary preclinical or clinical data supporting the therapeutic approach, access to appropriate patient populations, and institutional capacity to conduct rigorous clinical trials. Geographic scope is primarily U.S.-based organizations, though international collaborators may participate. The grant supports drug development activities including clinical protocol development, regulatory navigation, trial execution, and biomarker assessment specific to AD/ADRD therapeutics.
Program 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.
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 academic research institutions, pharmaceutical companies, and biotech organizations advancing novel therapeutics through early-stage clinical development for Alzheimer's Disease and related dementias. The UG3/UH3 mechanism supports the seamless transition from Phase 1 to Phase 2a clinical trials, making it appropriate for organizations with established clinical research capabilities and regulatory expertise. Applicants must demonstrate preliminary preclinical or clinical data supporting the therapeutic approach, access to appropriate patient populations, and institutional capacity to conduct rigorous clinical trials. Geographic scope is primarily U.S.-based organizations, though international collaborators may participate. The grant supports drug development activities including clinical protocol development, regulatory navigation, trial execution, and biomarker assessment specific to AD/ADRD therapeutics.
How to apply
Application links
Required documents
- SF-424 R&R (Research & Related) application form
- Project Narrative (research strategy section with specific aims, background, innovation, approach, and significance)
- Biographical Sketches (key personnel, NIH format, up to 5 pages each)
- Budget Narrative and Detailed Budget (Form PHS 398)
- Budget Justification addressing all personnel, equipment, and other direct costs
- Current and Pending Support documentation for all key personnel
- Letters of Support from collaborating institutions and clinical trial sites
- Institutional Biosafety Committee (IBC) clearance or exemption documentation if applicable
- Institutional Review Board (IRB) approval for human subjects research
- Preliminary Data and Publications supporting the proposed therapeutic approach
- Vertebrate Animals Section (IACUC approval) if animal studies included
- Resource Sharing Plan (data sharing and biospecimen management)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who is eligible to apply for this grant?
Academic medical centers, research universities, pharmaceutical companies, biotech startups, clinical research organizations, and NIH-designated cancer centers with clinical trial experience and appropriate facilities can apply. Applicants must have IRB approval capabilities and experience with drug development.
What is the timeline and application deadline?
Applications open November 22, 2024, with a fixed deadline of November 19, 2026. The UG3 phase typically lasts 2 years (development), followed by UH3 phase for clinical execution (approximately 3-4 years additional).
What types of research activities are supported?
The grant supports Phase 1 to Phase 2a clinical trials for novel AD/ADRD therapeutics, including protocol development, regulatory submissions, patient recruitment and enrollment, trial execution, safety and efficacy monitoring, and biomarker validation.
How competitive is this grant mechanism?
Very competitive. Applicants need robust preliminary data, clear regulatory pathway planning, and demonstrated clinical trial infrastructure. NIH typically funds a limited number of these high-stakes development awards annually.
What is the typical funding range?
UG3/UH3 grants typically provide $500,000-$2,000,000 per year depending on scope, with direct costs varying by project complexity and patient population requirements.
💡 Tips for applicants
- Develop a compelling regulatory strategy upfront: detail your pathway to FDA engagement, anticipated regulatory interactions, and risk mitigation plans to demonstrate feasibility.
- Invest heavily in preliminary data: strong Phase 1 safety/tolerability data or compelling preclinical evidence specific to AD/ADRD mechanisms will significantly strengthen competitiveness.
- Address patient population and recruitment: provide realistic enrollment timelines, describe your access to AD/ADRD patient populations, and outline retention strategies given the special needs of this population.
- Assemble a multidisciplinary team: include clinical investigators, biostatisticians, AD clinical experts, and biomarker specialists to demonstrate comprehensive expertise across the translational pathway.
- Emphasize unmet clinical need and differentiation: clearly articulate why your therapeutic approach is novel, how it addresses limitations of existing treatments, and what clinical benefits are anticipated versus current standard of care.
⚠️ Common mistakes
Applicants often fail by presenting underdeveloped preliminary data that doesn't adequately de-risk the transition to clinical trials, or by underestimating the regulatory complexity and timeline required for AD therapeutics. Another frequent pitfall is insufficient detail on patient recruitment and site capacity—reviewers need confidence you can actually enroll and retain cognitively impaired patients across the proposed trial duration.
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