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Federal

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

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

About this opportunity

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).

Who can apply

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

Additional eligibility information: 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).

Each funder sets its own eligibility, so check the details on their page before you apply.