Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)
Can you apply?
This grant is for research institutions and universities developing genomic and biologic therapies for Alzheimer's disease-related dementias (ADRD). Eligible organizations include NIH-grantee institutions, academic medical centers, and research organizations with the capacity to conduct translational research and clinical trials. Projects may span optimization, IND development, and early-stage clinical evaluation of therapeutic candidates with strong preclinical evidence.
The program prioritizes research on frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID). Activities include therapeutic design refinement, pharmacology and toxicology studies, biodistribution analysis, and first-in-human clinical trials when appropriate.
This is a highly competitive program for mature research teams with established translational pipelines. Applications require collaborative partnerships and demonstrated capacity in regulatory submissions and clinical development.
Key dates
- Feb 12, 2026 Applications open
- Nov 10, 2026 Application deadline in 161 days
- Jul 1, 2027 Award announced
- Jul 1, 2027 Project start
This grant is for research institutions and universities developing genomic and biologic therapies for Alzheimer's disease-related dementias (ADRD). Eligible organizations include NIH-grantee institutions, academic medical centers, and research organizations with the capacity to conduct translational research and clinical trials. Projects may span optimization, IND development, and early-stage clinical evaluation of therapeutic candidates with strong preclinical evidence.
The program prioritizes research on frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID). Activities include therapeutic design refinement, pharmacology and toxicology studies, biodistribution analysis, and first-in-human clinical trials when appropriate.
This is a highly competitive program for mature research teams with established translational pipelines. Applications require collaborative partnerships and demonstrated capacity in regulatory submissions and clinical development.
Program description
The National Institutes of Neurological Disorders and Stroke (NINDS) is interested in supporting research projects proposing the optimization and translational development of genomic and biologic therapeutic candidates for Alzheimer’s Disease-Related Dementias (ADRD). Breakthroughs in genomic and biologic therapies are creating new opportunities to treat, prevent, and potentially modify the course of dementias; however, progress is limited by challenges in delivery, safety, manufacturability, and readiness for clinical testing.
This program is intended to support projects across the translational pipeline, from optimization through IND development and early clinical evaluation, for genomic and biologic therapeutic candidates with compelling preclinical evidence. Eligible projects may include activities to refine therapeutic design and manufacturability; establish pharmacology, toxicology, biodistribution, and in vivo efficacy; to generate the full body of data required to support regulatory interactions and IND submissions, and, when appropriate, first-in-human (FIH) clinical studies.
The program is aligned with priorities from the ADRD Summits, including acceleration of disease-modifying therapeutic development in frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID). 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.
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
Demographic focus
Details
This grant is for research institutions and universities developing genomic and biologic therapies for Alzheimer's disease-related dementias (ADRD). Eligible organizations include NIH-grantee institutions, academic medical centers, and research organizations with the capacity to conduct translational research and clinical trials. Projects may span optimization, IND development, and early-stage clinical evaluation of therapeutic candidates with strong preclinical evidence.
The program prioritizes research on frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID). Activities include therapeutic design refinement, pharmacology and toxicology studies, biodistribution analysis, and first-in-human clinical trials when appropriate.
This is a highly competitive program for mature research teams with established translational pipelines. Applications require collaborative partnerships and demonstrated capacity in regulatory submissions and clinical development.
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) form
- Project Narrative (specific page limits from RFP)
- Detailed Budget and Budget Justification
- Biographical sketches (biosketches) for key personnel
- Resources/Environment description
- Letters of Support from collaborating institutions
- IND-readiness assessment or regulatory strategy document
- Preliminary data supporting therapeutic candidate
- Clinical trial protocol (if FIH studies included)
Program contact
- 👤 NINDS ADRD Program
- 📧 nindsdonadrd@mail.nih.gov
- 📞 Please contact via e-mail
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$82,511,281
-
$67,362,785
-
$62,646,087
-
$56,144,651
-
$45,268,737
-
$40,959,789
-
$35,655,349
-
$35,655,116
-
$35,335,145
-
$34,183,297
Top States by Funding
- MA 6 awards $186.5M
- CA 4 awards $129.9M
- OH 4 awards $112.5M
- FL 3 awards $100.3M
- MN 2 awards $99.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who can apply for this grant?
Research institutions, universities, and NIH-grantee organizations with capacity for translational research and clinical trials. Organizations must have relevant expertise in genomic or biologic therapy development.
What types of projects are funded?
Projects from therapeutic optimization through IND development and early clinical evaluation. Eligible activities include manufacturability studies, pharmacology, toxicology, biodistribution, efficacy testing, and regulatory preparation.
Are there specific disease areas prioritized?
Yes, the program emphasizes frontotemporal degeneration, Lewy body dementia, and vascular contributions to cognitive impairment and dementia. Research on other ADRD subtypes is also considered.
What is the timeline for this funding opportunity?
The deadline is November 10, 2026. The program uses a fixed deadline. Applicants should begin developing collaborations and research plans well in advance.
Is cost-sharing required?
No, cost-sharing is not required for this grant. However, demonstrating institutional commitment through resources can strengthen competitiveness.
💡 Tips for applicants
- Start collaboration discussions early. This program requires strong partnerships between research groups and potential clinical sites.
- Develop detailed translational timelines. Show clear progression from preclinical evidence through IND submission to clinical readiness.
- Address manufacturability and safety explicitly. Reviewers prioritize projects that have solved real-world production and safety challenges.
- Build regulatory strategy into your proposal. Include plans for FDA interactions and IND-enabling studies from the start.
- Highlight preliminary data quality. Compelling preclinical evidence is non-negotiable for competitiveness in this program.
⚠️ Common mistakes
Submitting projects without sufficient preclinical evidence or clear path to IND development. Underestimating the cost and timeline needed for manufacturing optimization and regulatory-required studies. Failing to demonstrate institutional resources and clinical trial infrastructure required for early-stage human studies.
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