Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer’s Disease/Alzheimer’s Disease-Related Dementias and Age-Related Cognitive Decline
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for researchers and research institutions conducting clinical trials focused on Alzheimer's disease, Alzheimer's disease-related dementias, and age-related cognitive decline. Eligible recipients typically include universities, academic medical centers, hospitals, research institutes, and 501(c)(3) nonprofit research organizations. Applicants must have institutional capacity to conduct rigorous clinical research, including IRB approval capability and the infrastructure to manage multi-site trials if applicable. The grant supports both early-stage (Phase I/II) and late-stage (Phase III/IV) clinical trial research, including therapeutic interventions, diagnostic tools, and preventive approaches across the full spectrum of cognitive aging disorders. Geographic scope is nationwide and international collaboration is permitted where appropriate.
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Key dates
- Jun 27, 2025 Applications open
- Oct 5, 2025 Application deadline
- Jul 1, 2026 Award announced
- Jul 1, 2026 Project start
Program description
The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) to 1) invite applications that propose to develop and implement early- to late-stage clinical trials of promising pharmacological and non-pharmacological interventions to prevent and/or treat the cognitive, behavioral, and neuropsychiatric changes associated with age-related cognitive decline and Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD), and 2) stimulate studies to enhance trial design and methods. 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. This NOFO intends to utilize the R01 activity code. Investigators with expertise and insights into this area of aging research are encouraged to begin to consider applying for this new NOFO.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- County Government
- Hospital
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative/Research Plan (typically 15 pages for R01s)
- Biographical sketches of key personnel (NIH format, 2 pages each)
- Budget and Budget Justification
- Institutional support letter and IRB approval status
- Letters of collaboration from study sites or partner institutions
- Clinical trial protocol and informed consent form (IFC) or draft IFC
- Statistical analysis plan
- Data and Safety Monitoring Plan (for Phase II and later trials)
Program contact
- 👤 Laurie Ryan, Ph.D. National Institute on Aging (NIA)
- 📧 ryanl@mail.nih.gov
- 📞 301-496-9350
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
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$463,372,200
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$172,327,224
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$115,145,694
-
$99,649,073
-
$93,275,174
-
$82,572,681
-
$81,344,612
-
$78,657,309
-
$75,825,492
-
$75,398,895
Top States by Funding
- CA 10 awards $633.7M
- MI 2 awards $511.9M
- MO 8 awards $453.5M
- 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 is eligible to apply for this NIH clinical trials grant?
Universities, academic medical centers, hospitals, nonprofit research institutions, and private research organizations with 501(c)(3) status are typically eligible. Individual researchers must be affiliated with an eligible institution. The applicant institution must have adequate infrastructure, IRB approval capability, and experience managing clinical research.
What types of clinical trial research are supported?
The program supports Phase I through Phase IV clinical trials investigating therapeutics, diagnostics, biomarkers, and prevention strategies for Alzheimer's disease, related dementias, and age-related cognitive decline. Both pharmacological and non-pharmacological interventions may be supported.
What is the timeline for applications and funding?
The application window opens June 27, 2025. NIH typically has rolling deadlines; check the NIH Guide for specific submission dates. Standard R01 grants typically have project periods of 3-5 years, though this may vary by award type.
How competitive is this funding?
NIH clinical trials grants are highly competitive (typically 8-12% success rate). Strong preliminary data, feasibility demonstration, and experienced research teams are critical. Reviewer preference is given to studies addressing significant gaps in understanding or treatment of cognitive aging disorders.
What is the typical funding range?
This varies by award mechanism and trial phase. NIH typically provides $250,000-$2,000,000+ annually depending on trial complexity, number of sites, and enrollment targets. Actual amounts vary; review the specific FOA (Funding Opportunity Announcement) for guidance.
💡 Tips for applicants
- Start with strong preliminary data: reviewers want evidence your research team can execute the proposed trial. Include pilot study results or Phase I data demonstrating feasibility and scientific rationale.
- Be specific about your clinical trial design and statistical power: clearly define primary and secondary endpoints, inclusion/exclusion criteria, sample size justification, and why your approach is superior to existing methods. Vague methodology is a common rejection reason.
- Address recruitment and retention strategies explicitly: detail your plan to enroll and retain participants across the trial timeline. Include partnerships with patient registries, clinical centers, or community organizations if applicable.
- Align with NIH priorities on health disparities and inclusion: demonstrate how your trial design ensures diverse participant representation (age, sex, race/ethnicity, socioeconomic status). Exclusionary designs face increased scrutiny.
- Build a collaborative, experienced research team: include co-investigators with proven track records in clinical research, biostatisticians experienced with trial design, and site investigators if multi-site. Weak team composition is frequently cited in reviews.
⚠️ Common mistakes
Many applications underestimate the complexity of recruitment and retention planning, providing vague timelines rather than concrete partnerships and enrollment projections. Reviewers also frequently cite insufficient preliminary data or proof-of-concept—moving to a full trial without Phase I validation raises concerns about feasibility and scientific validity.
Similar grants
- CLOSED Alzheimer’s Clinical Trials Consortium (ACTC) Clinical Trials — National Institutes of Health
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- CLOSED Dementia Care and Caregiver Support Intervention Research – Stage I Only — National Institutes of Health
- CLOSED Specialized Center Cooperative Agreements in Aging and/or Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Research — National Institutes of Health
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