Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)
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The National Institutes of Neurological Disorders and Stroke (NINDS) is preparing to support research aimed at optimizing and advancing genomic and biologic therapeutic candidates for Alzheimer’s Disease-Related Dementias (ADRD). This initiative focuses on overcoming current challenges such as delivery methods, safety, manufacturability, and clinical readiness, leveraging recent advancements in genomic and biologic therapies that offer promising avenues for treatment, prevention, and potentially altering the progression of dementias. The program is designed to back projects spanning the translational pipeline—from therapeutic candidate optimization and manufacturability to establishing pharmacology, toxicology, biodistribution, and in vivo efficacy, ultimately generating the comprehensive data needed for regulatory interactions, Investigational New Drug (IND) submissions, and early clinical trials, including first-in-human studies when applicable. Aligned with priorities established through ADRD Summits, this program targets accelerating disease-modifying therapies specifically for frontotemporal degeneration, Lewy body dementia, and vascular contributions to cognitive impairment and dementia. While applications are not currently being solicited, this advance notice aims to give prospective applicants adequate time to form collaborations and develop responsive research proposals. The program is offered through the National Institutes of Health under the Department of Health and Human Services, with contact available via the NINDS ADRD Program for inquiries and further information.
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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.