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

The National Institutes of Health (NIH), through participating components including the National Institute on Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS), and National Institute of Dental and Craniofacial Research (NIDCR), has issued this Notice of Funding Opportunity (NOFO) to support research on current topics in Alzheimer’s Disease (AD) and its related dementias (ADRD). These diseases, such as Frontotemporal Dementia, Lewy Body Dementias, Vascular Contributions to Cognitive Impairment and Dementia, and Multiple Etiology Dementias, significantly impact aging populations. Alzheimer’s is a leading cause of death in the U.S., and with over six million Americans currently affected, the NIH has prioritized advancing understanding and treatment of these disorders through initiatives like the National Alzheimer’s Project Act (NAPA) and associated research summits. This funding opportunity supports projects that propose biomedical, behavioral, or social science research focused on AD/ADRD. The initiative encourages innovative interdisciplinary approaches to explore disease mechanisms, clinical symptoms, care, and caregiving challenges. A series of Notices of Special Interest (NOSIs) will be released to clarify specific topics of interest under this NOFO. Applicants may propose clinical trials, though they are not required. The program is aligned with agency priorities and aims to develop effective interventions and improve understanding of disease heterogeneity. Budgets are not capped but must reflect the actual needs of the project, with a maximum project period of five years. There are no mandatory cost-sharing or matching requirements. Application types include new, renewal, resubmission, and revision proposals. The use of resources such as the NIA Clinical Research Operations & Management System (CROMS) and OutreachPro is encouraged to support recruitment and data management, particularly in engaging underserved populations. Eligible applicants include a broad range of domestic and foreign organizations: higher education institutions, nonprofits, for-profits, government entities, school districts, housing authorities, tribal organizations, and faith- or community-based groups. Applicant institutions must be registered with SAM, eRA Commons, and Grants.gov. Principal investigators must also have active eRA Commons accounts. Applications must be submitted electronically through NIH’s ASSIST platform, Grants.gov Workspace, or institutional system-to-system solutions. Multiple NIH standard due dates apply: March 11, June 5, October 5, and February 5 annually through October 2027. Although this notice is currently marked as expired (as of November 20, 2025), applicants may still be eligible under NIH’s late or continuous submission policies, subject to confirmation with the eRA Service Desk. The original expiration was November 6, 2027. Applicants are advised to follow all formatting and submission instructions detailed in the NIH Application Guide. Applications are peer-reviewed for scientific merit based on significance, innovation, approach, investigator qualifications, and institutional environment. The earliest possible start date for awards is approximately 4–6 months after submission. All applications must comply with NIH data sharing, human subjects, and ethical guidelines.