Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), through the National Institute on Aging (NIA), the National Institute of Neurological Disorders and Stroke (NINDS), and the newly added National Institute of Dental and Craniofacial Research (NIDCR), invites applications under the Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional) funding opportunity. This reissued opportunity, PAR-25-332, succeeds PAR-22-093 and aims to support research advancing the understanding of Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD). These disorders include Frontotemporal Dementia (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD), and Multiple Etiology Dementias (MED). The program supports both basic and clinical research projects that address high-priority topics identified through national research summits and strategic plans like the National Alzheimer’s Project Act (NAPA). The primary goal of this Notice of Funding Opportunity (NOFO) is to encourage interdisciplinary biomedical, social, and behavioral research that contributes to a more profound understanding of the aging process and the diseases and needs associated with aging. The initiative focuses on advancing scientific knowledge to prevent, diagnose, and treat AD/ADRD, improve care for affected individuals, and address disparities in prevalence and outcomes among underserved populations. Research objectives are deliberately broad, allowing applicants to propose projects that align with strategic priorities established in prior AD/ADRD summits. Future notices may refine or highlight specific areas of interest. The funding mechanism used is the NIH R01 Research Project Grant, which supports discrete, specified projects conducted by named investigators in areas representing their specific interests and competencies. Clinical trials are optional under this NOFO. Award budgets are not capped and should reflect the actual needs of the project. The project period can last up to five years. There is no minimum or maximum number of awards stipulated; the number of awards depends on the NIH budget and the merit of submitted applications. Applicants must follow NIH’s standard application procedures via Grants.gov or NIH’s ASSIST platform. While a letter of intent is not required, applications must adhere strictly to the instructions in the NIH Application Guide. Applications are accepted on a rolling basis according to NIH’s standard due dates, beginning on February 11, 2025, with the first due date on March 11, 2025. Subsequent submission dates occur tri-annually through November 6, 2027. The opportunity is not subject to intergovernmental review and does not require cost sharing. Applicants must be fully registered in multiple systems including SAM, Grants.gov, and eRA Commons prior to submission. Eligible applicants include higher education institutions, nonprofits, for-profit organizations (including small businesses), local and state governments, tribal organizations, housing authorities, school districts, and foreign entities. Special emphasis is placed on projects involving human subjects, and applicants are encouraged to include diverse populations and address health disparities. Projects involving $500,000 or more in direct costs in any one year must consult with NIH program staff six weeks before submission. A thorough recruitment and retention plan, as well as compliance with data sharing policies and informed consent requirements, is mandatory for all applicants proposing human subjects research. Scientific and peer review will consider three main factors: the importance of the research, rigor and feasibility, and the expertise and environment supporting the work. Award notices will be issued to successful applicants after advisory council review, with anticipated start dates beginning in December 2025. Contact points include Jean Yuan (NIA) at jean.yuan@nih.gov, Frank Paul Shewmaker (NINDS) at frank.shewmaker@nih.gov, and Philip Smith (Grants Management Officer, NIA) at philip.smith2@nih.gov.