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

Agency: National Institutes of Health

Assistance Listings: 93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders

Last Updated: February 12, 2026

Description

The National Institutes of Neurological Disorders and Stroke (NINDS) is interested in supporting research projects proposing the optimization and translational development of genomic and biologic therapeutic candidates for Alzheimer’s Disease-Related Dementias (ADRD). Breakthroughs in genomic and biologic therapies are creating new opportunities to treat, prevent, and potentially modify the course of dementias; however, progress is limited by challenges in delivery, safety, manufacturability, and readiness for clinical testing.

This program is intended to support projects across the translational pipeline, from optimization through IND development and early clinical evaluation, for genomic and biologic therapeutic candidates with compelling preclinical evidence. Eligible projects may include activities to refine therapeutic design and manufacturability; establish pharmacology, toxicology, biodistribution, and in vivo efficacy; to generate the full body of data required to support regulatory interactions and IND submissions, and, when appropriate, first-in-human (FIH) clinical studies.

The program is aligned with priorities from the ADRD Summits, including acceleration of disease-modifying therapeutic development in frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID). Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

Eligibility

Eligible applicants

Nonprofit

  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)
  • Other Native American tribal organizations

Government

  • Special district governments
  • County governments
  • State governments
  • Public and Indian housing authorities
  • City or township governments
  • Federally recognized Native American tribal governments

Miscellaneous

  • Other

Education

  • Independent school districts
  • Private institutions of higher education
  • Public and state institutions of higher education

Business

  • For-profit organizations other than small businesses
  • Small businesses

Additional information

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible 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).

Grantor contact information

Description

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Email

nindsdonadrd@mail.nih.gov

nindsdonadrd@mail.nih.gov

Documents

No documents are currently available.

Link to additional information

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Forecasted

Estimated Post Date:

July 1, 2026

Estimated Application Due Date:

November 10, 2026

Estimated Due Date Description:

Not available

Estimated Award Date:

July 1, 2027

Estimated Project Start Date:

July 1, 2027

Fiscal Year:

2027

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$6,000,000

Program Funding

3

Expected awards

$--

Award Minimum

$--

Award Maximum

Funding opportunity number:

RFA-NS-26-030

Cost sharing or matching requirement:

No

Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

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Category of Funding Activity:

Health

Category Explanation:

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History

Version:

1

Forecast posted date:

February 12, 2026

Archive date:

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