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

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RFA-NS-28-012Grant

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The National Institute of Neurological Disorders and Stroke, under the National Institutes of Health, has issued solicitation RFA-NS-28-012 to support the translation of genome editing and biologic therapies for Alzheimer's Disease-Related Dementias. This initiative covers a broad range of conditions, including Frontotemporal Dementia, Lewy Body Dementias, Vascular Contributions to Cognitive Impairment and Dementia, and Multiple Etiology Dementias. The program is designed to advance the translational pipeline from initial therapeutic lead optimization and drug product development through IND-enabling studies and early clinical evaluation. Eligible activities include the optimization of delivery systems and editing constructs, the assessment of bioactivity and pharmacokinetics, and the demonstration of in vivo efficacy. Additionally, the funding supports safety pharmacology, toxicology studies, and the creation of scalable manufacturing processes and quality attributes that meet regulatory standards. This solicitation was posted on November 3, 2026, with a response deadline of October 11, 2028.

General Info

NIH funding for translating genome editing and biologic therapies for Alzheimer's related dementias.

Agency

National Institutes Of Health → National Institute Of Neurological Disorders And Stroke

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Timeline

PhaseSolicitation
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Organization & Contact Information

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AgencyNational Institutes Of Health → National Institute Of Neurological Disorders And Stroke
ContactsNo contacts available
OfficeUSA
Organization / AgencyNational Institutes Of Health → National Institute Of Neurological Disorders And Stroke
Office AddressUSA
ContactsNo contact information available

Full Description

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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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