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

The summary for the Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

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

Federal Grant Title:	Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)
Federal Agency Name:	National Institutes of Health (HHS-NIH11)
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-NS-28-012
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.866, 93.NS1
CFDA Descriptions:	Information not provided
Current Application Deadline:	October 10th, 2028
Original Application Deadline:	October 10th, 2028
Posted Date:	November 3rd, 2026
Creation Date:	November 3rd, 2026
Archive Date:	December 9th, 2028
Total Program Funding:	$6,000,000
Maximum Federal Grant Award:	$2,500,000
Minimum Federal Grant Award:
Expected Number of Awards:	3
Cost Sharing or Matching:	No
Last Updated:	November 3rd, 2026

Applicants Eligible for this Grant: State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - 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 - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on 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).
Grant Announcement Contact: NINDS ADRD Program
[email protected]
[email protected]
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