Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer's Disease/Alzheimer's Disease-Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)

Background
The National Institute on Aging (NIA) under the Department of Health and Human Services is inviting applications for early- to late-stage clinical trials of promising pharmacological and non-pharmacological interventions to prevent and/or treat the cognitive, behavioral, and neuropsychiatric changes associated with age-related cognitive decline and Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD). The purpose is to accelerate the development of interventions to prevent, slow, or cure AD/ADRD as part of the National Alzheimer's Project Act (NAPA) goals.

Grant Details
The NOFO supports early-stage clinical testing of promising pharmacological and non-pharmacological interventions, studies to enhance trial design and methods, and late-stage clinical trials testing pharmacological and non-pharmacological interventions. It encourages studies to refine intervention strategy, evaluate safety and/or efficacy of the intervention(s), elucidate mechanism of action, define and refine the target population, ensure adequate enrollment, protocol adherence, subject retention, address heterogeneity of response, establish/validate trial outcome measures. The NOFO also emphasizes inclusivity in research involving human subjects.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, government agencies at various levels, foreign entities, faith-based or community-based organizations. Individuals from diverse backgrounds are encouraged to apply. Applicants must complete required registrations such as SAM registration, NATO Commercial and Government Entity (NCAGE) Code for foreign organizations, Unique Entity Identifier (UEI), eRA Commons account for PD(s)/PI(s), and Grants.gov registration.

Period of Performance
The maximum project period is 5 years. The earliest start date is October 17, 2024. All applications are due by 5:00 PM local time of applicant organization. The expiration date for this opportunity is October 18, 2024.

Grant Value
NIA will commit approximately $20,000,000 to support clinical trials of varying size and scope as well as studies to enhance clinical trial design and methods in fiscal year 2025. Application budgets are not limited but need to reflect the actual needs of the proposed project.