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

Forecasted opportunity (not yet open for applications; expected to be posted around 2026-07-01; estimated application due date 2026-11-10). 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.