Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)
HHS-NIH11 Posted RFA-NS-28-012
Close Date:
October 10, 2028
704 days remaining
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).
Eligibility
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).
Actions
Funding Details
- Award Floor
- Not specified
- Award Ceiling
- $2,500,000.00
- Total Estimated Funding
- $6,000,000.00
- Expected Awards
- 3
Key Dates
- Posted
- November 3, 2026
- Closes
- October 10, 2028 704d
- Archive Date
- December 9, 2028
Agency Information
- Agency Name
- National Institutes of Health
- Agency Code
- HHS-NIH11
- Funding Instrument
- Other