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

ID: RFA-NS-26-030 • Type: Forecasted
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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.

Background
The National Institutes of Neurological Disorders and Stroke (NINDS) aims to support research projects focused on optimizing and developing genomic and biologic therapeutic candidates for Alzheimer’s Disease-Related Dementias (ADRD). The program seeks to address challenges in delivery, safety, manufacturability, and readiness for clinical testing of these therapies, which have the potential to treat, prevent, and modify the course of dementias. This initiative aligns with priorities from ADRD Summits aimed at accelerating the development of disease-modifying therapies for conditions such as frontotemporal degeneration (FTD), Lewy body dementia (LBD), and vascular contributions to cognitive impairment and dementia (VCID).

Grant Details
The program supports projects across the translational pipeline from optimization through IND development and early clinical evaluation for genomic and biologic therapeutic candidates that demonstrate compelling preclinical evidence. Eligible activities may include refining therapeutic design and manufacturability; establishing pharmacology, toxicology, biodistribution, and in vivo efficacy; generating comprehensive data to support regulatory interactions and IND submissions; and conducting first-in-human (FIH) clinical studies when appropriate.

Eligibility Requirements
Eligible projects must demonstrate compelling preclinical evidence for genomic and biologic therapeutic candidates.
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Overview

Agency
National Institutes of Health (NIH) [HHS]
Category of Funding
Health
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 2/12/26 the National Institutes of Health forecasted grant opportunity RFA-NS-26-030 for Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional) with funding of $6.0 million. The grant will be issued under grant program 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders. It is expected that 3 total grants will be made.

Timing

Forecast Posted Date
Feb. 12, 2026, 12:00 a.m. EST
Est. Application Posting Date
July 1, 2026, 12:00 a.m. EDT
Est. Synopsis Response Date
Nov. 10, 2026, 12:00 a.m. EST Forecasted
Last Updated
Feb. 12, 2026, 8:45 a.m. EST
Version
1

Eligibility

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

Award Sizing

Ceiling
Not Listed
Floor
Not Listed
Estimated Program Funding
$6,000,000
Estimated Number of Grants
3

Contacts

Contact
NINDS ADRD Program
Contact Email
nindsdonadrd@mail.nih.gov

Documents

Posted documents for RFA-NS-26-030

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