View Grant Opportunity

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

National Institutes of Health

RFA-NS-28-012

HHS-NIH11

General Information

$6,000,000
Est. Program Funding:
October 10, 2028
Closing Date:
3
Expected No. of Awards
$2,500,000
Award Ceiling

Opportunity Number:
RFA-NS-28-012

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

Synopsis

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). 
Response Date Oct 10, 2028 12:00:00 AM EDT
Posting Date Nov 03, 2026 12:00:00 AM EST
Archive Date Dec 09, 2028 12:00:00 AM EST
Award Ceiling 2,500,000
Award Floor N/a
Cost Sharing No

Eligibility

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

Additional Information

Agency Name National Institutes of Health
Link to Additional Information: N/a
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk
Phone: 301-402-2541

CFDA Program(s)

  • 93.866: Aging Research
  • 93.NS1: Neurosciences and Neurological Disorders – Research Projects (RP)
   

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Request Grant Support from GTC 360° Advisors

Our expert team at GTC 360° Advisors can help develop your grant strategy, recruit partner organizations, write your full proposal, compile and manage your budgets, and help you submit a compelling and compliant proposal on time.