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OpenU01NINDSClinical trial: Optional / allowed

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

National Institute of Neurological Disorders and Stroke (NINDS) · NIH Institute/Center · RFA-NS-28-012

Source: Grants.gov · View original posting ↗

Award
Up to $2.5M
Deadline
Oct 10, 2028
Letter of intent
—
Mechanism
U01
Duration
—
Expected awards
3
Funding cycle
One-time
Open date
Nov 3, 2026
Total funding
$6M total
Clinical trial
Optional / allowed
Established investigatorGovernmentSmall businessHigher educationNonprofitForeign entities

Research areas

Therapeutics & drug discovery

Auto-classified from the title and description (keyword-based) — may be imperfect.

Description

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).