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Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)

Open

National Institutes of Health · Opportunity number RFA-NS-28-012

PostedNov 3, 2026
Closing dateOct 10, 2028
Award ceiling$2,500,000
Expected awardsNot listed
From Grants.gov

Eligibility

Nonprofits are listed as eligible applicants.

  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Small businesses
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • Special district governments
  • State governments
  • County governments
  • City or township governments
  • For profit organizations other than small businesses
  • Public and state controlled institutions of higher education
  • Private institutions of higher education

Other Eligible ApplicantsEligible 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).

Description

This Notice of Funding Opportunity (NOFO) supports the translation of genome editing and other biologic therapies for Alzheimer's Disease-Related Dementias (ADRD). The program spans the full translational pipeline, from therapeutic lead optimization and drug product development through IND-enabling studies and early clinical evaluation. Supported activities may include optimization of editing constructs and delivery systems; assessment of bioactivity, target engagement, durability, pharmacokinetics, and bioavailability; demonstration of in vivo efficacy; execution of safety pharmacology and toxicology studies; and development of scalable manufacturing processes, formulation strategies, and quality attributes aligned with regulatory expectations. ADRD include Frontotemporal Dementia (FTD); Lewy Body Dementias (LBD), including Dementia with Lewy Bodies (DLB) and Parkinson's Disease Dementia (PDD); Vascular Contributions to Cognitive Impairment and Dementia (VCID); and Multiple Etiology Dementias (MED).

Funding

Total program funding$6,000,000
Award floorNot listed
Award ceiling$2,500,000
CategoryHealth
Assistance listing93.866, 93.NS1

Official sources

Last verified on Grants.gov Nov 4, 2026. Grantvello is not affiliated with Grants.gov or National Institutes of Health. The notice on Grants.gov is the binding text.