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

The National Institutes of Health (NIH) is seeking research projects that propose the optimization and translational development of genomic and biologic therapeutic candidates for Alzheimer’s Disease-Related Dementias (ADRD). The program aims to support projects across the translational pipeline, from optimization through IND development and early clinical evaluation. Eligible projects may include activities such as refining therapeutic design and manufacturability, establishing pharmacology and toxicology, and generating data required for regulatory interactions and IND submissions. • 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, but notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. • The estimated funding for this program is $6,000,000, and the estimated number of awards is 3.