Pilot Studies for the Spectrum of Alzheimers Disease/Alzheimers Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional)

The National Institutes of Health (NIH), through the National Institute on Aging (NIA), has announced a funding opportunity (PAR-23-083) for pilot studies related to Alzheimer’s Disease (AD), Alzheimer’s Disease-Related Dementias (ADRD), and age-related cognitive decline. This opportunity invites applications for exploratory studies to gather preliminary data that can support early-stage clinical testing of pharmacological and non-pharmacological interventions aimed at cognitive and neuropsychiatric issues across the spectrum of AD and ADRD. These pilot studies are intended to address aspects such as intervention feasibility, safety, tolerability, and subject selection, while laying the groundwork for future, larger-scale trials. The purpose of this FOA is twofold: first, to encourage the collection of pilot data to inform clinical trials for interventions addressing cognitive decline and AD/ADRD; and second, to stimulate improvements in trial design and methodology. The targeted interventions include a wide range of approaches, from small molecule drugs to lifestyle and cognitive therapies. Studies under this FOA may also focus on repurposing existing drugs, combining pharmacological and non-pharmacological strategies, or refining interventions that have shown efficacy in non-AD populations for use in AD/ADRD contexts. Applications should also explore mechanisms of action, optimize intervention strategies (e.g., dosage or delivery), and assess trial outcome measures. The funding mechanism for this opportunity is the R61 Exploratory/Developmental Grant, offering direct costs up to $325,000 per year for up to two years. NIH plans to fund approximately five projects, with a total annual budget of $2.5 million, contingent on annual appropriations. Applications will be reviewed based on criteria including significance, innovation, approach, and the investigators' qualifications, with special attention given to study design, statistical analysis, and trial feasibility. Both U.S. and foreign institutions are eligible to apply. Eligible applicants include public and private institutions of higher education, nonprofit organizations, for-profit organizations, small businesses, and various government and tribal entities. Non-U.S. organizations are also eligible. There are no limitations on the number of applications per institution, provided that each application is scientifically distinct. Submissions must comply with all NIH and FOA-specific guidelines, and applicants are encouraged to utilize the NIH ASSIST system or Grants.gov Workspace for submission. Compliance with NIH’s new FORMS-H for grant application submission is mandatory for applications due after January 25, 2023. Key submission dates include multiple cycles through 2024, with the next deadlines on November 17, 2023, and subsequent dates into November 2024. Applicants should submit their proposals by 5:00 PM local time of their organization. Importantly, late applications will not be accepted except under special circumstances. This FOA offers a crucial opportunity to advance early-stage intervention research for AD, ADRD, and age-related cognitive decline, supporting the development of new therapies and intervention strategies that could mitigate the public health burden of dementia as populations age.