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forecasted

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

National Institutes of Health · RFA-NS-26-030

Award range

See source for award amount

Deadline

Not specified

Eligible applicants

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

Geographic eligibility and all attachment-specific conditions require review of the original announcement.

Eligibility details

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).

Matching funds & resources

Source matching-funds field: Not Required.

Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.

About this opportunity

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.

Funding geography: Not specified — review source. A funder’s address does not establish eligibility.

Review original source ↗

Funding instrument: Cooperative Agreement. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.

Source fields and evidence

id: 361287
Source ↗ · id

opportunityNumber: RFA-NS-26-030
Source ↗ · opportunityNumber

opportunityTitle: Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)
Source ↗ · opportunityTitle

revision: 0
Source ↗ · revision

agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails

owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode

cfdas: [{"id":431942,"opportunityId":361287,"cfdaNumber":"93.853","programTitle":"Extramural Research Programs in the Neurosciences and Neurological Disorders"}]
Source ↗ · cfdas

forecastDesc: <p>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.</p><p>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.</p><p>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.&nbsp;</p>
Source ↗ · forecastDesc

applicantTypes: [{"id":"02","description":"City or township governments"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"05","description":"Independent school districts"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"23","description":"Small businesses"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"00","description":"State governments"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"20","description":"Private institutions of higher education"},{"id":"04","description":"Special district governments"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"01","description":"County governments"}]
Source ↗ · applicantTypes

applicantEligibilityDesc: 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).
Source ↗ · applicantEligibilityDesc

fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
Source ↗ · fundingInstruments

fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories

costSharing: false
Source ↗ · costSharing

lastUpdatedDate: Feb 12, 2026 08:45:42 AM EST
Source ↗ · lastUpdatedDate

status: forecasted
Source ↗ · oppHits[id=361287].oppStatus

Source retrieved 10/15/2026 · Revision 0. Always confirm current requirements and dates with the funder. Structured source fields are checked; this is not a determination that every applicant qualifies.

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