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

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Key Information

Due Date: October 10, 2028


Agency: United States Department of Health and Human Services


Source: Federal


Website: View Website


Funding Categories:

Funding Amount: $6,000,000


Funding Type: Cooperative Agreement


Match Required: No


Status: Posted


Contact Info: nindsdonadrd@mail.nih.gov
NINDS ADRD Program nindsdonadrd@mail.nih.gov

Overview

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).

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Additional Info

Posted Date: November 3, 2026


Application Due Date: October 10, 2028


Estimated Award Date: Not Specified


Eligible Applicants:

  • Special district governments
  • County governments
  • Native American tribal governments (Federally recognized)
  • Private institutions of higher education
  • For profit organizations other than small businesses
  • Independent school districts
  • Others
  • State governments
  • City or township governments
  • 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
  • Small businesses
  • 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
  • Public and State controlled institutions of higher education
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