Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)
Forecasted Federal grant Posted
- Opportunity number
- RFA-NS-26-030
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications expected due
- Award size
- Not on record
Opportunity facts
- Expected posting
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- 501(c)(3) Nonprofits
- Special District Governments
- County Governments
- Other
- Independent School Districts
- State Governments
- For Profit Organizations
- Non-501(c)(3) Nonprofits
- Public or Indian Housing Auth.
- City/Township Governments
- Higher Education Inst. (Private)
- Small Businesses
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Public)
- Tribal Governments (Federally Recognized)
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Neurological Disorders and Stroke (NINDS) is forecasting a cooperative agreement to support translational development of genomic and biologic therapeutic candidates for Alzheimer's Disease-Related Dementias (ADRD); applications are not currently being solicited, and this notice allows potential applicants time to develop collaborations and responsive projects.
Eligible applicants include 501(c)(3) and non-501(c)(3) nonprofits, higher education institutions (public and private), small businesses, for-profit organizations, tribal governments (federally and non-federally recognized), state and local governments, special district governments, independent school districts, public or Indian housing authorities, faith-based and community-based organizations, U.S. territories and possessions, regional organizations, and non-domestic entities.
The program targets optimization and translational development across the pipeline from therapeutic design refinement through Investigational New Drug (IND) development and early clinical evaluation. Supported activities include refinement of therapeutic design and manufacturability; establishment of pharmacology, toxicology, biodistribution, and in vivo efficacy; generation of data supporting regulatory interactions and IND submissions; and first-in-human clinical studies where appropriate. The program emphasizes disease-modifying therapeutic development in frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID), aligned with priorities from ADRD Summits. Projects must address challenges in delivery, safety, manufacturability, and clinical testing readiness for genomic and biologic therapies with compelling preclinical evidence.
Assistance Listing 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders) applies. Award details, funding amount, period of performance, and cost-share requirements have not yet been specified in this forecast notice.
Forecast synopsis
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.
Eligibility
Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).
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