Pilot Studies for the Spectrum of Alzheimers Disease/Alzheimers Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional) | PAR 23 083

Opportunity Information: Apply for PAR 23 083

The National Institutes of Health (NIH) funding opportunity PAR-23-083, titled "Pilot Studies for the Spectrum of Alzheimers Disease/Alzheimers Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional)," is a discretionary grant program in the health area (CFDA 93.866) designed to push early, high-value pilot work forward in Alzheimers disease (AD), Alzheimers disease-related dementias (ADRD), and age-related cognitive decline. The core idea is to fund short, targeted studies that generate the kind of preliminary evidence needed to justify larger, later-stage projects, while also encouraging researchers to refine the practical mechanics of how these trials are designed and conducted.

The FOA has two main goals. First, it supports the collection of pilot data for early stage testing of promising interventions aimed at cognitive and neuropsychiatric changes across the full disease spectrum, from pre-symptomatic stages through more advanced impairment. These interventions can be pharmacological (for example, drug-based approaches) or non-pharmacological (for example, behavioral, lifestyle, cognitive, care-delivery, or other non-drug strategies), as long as they target cognition and/or neuropsychiatric symptoms relevant to aging, AD, or ADRD. Second, it aims to stimulate studies that improve trial design and methods, which can include work that strengthens recruitment strategies, outcome selection, measurement approaches, feasibility and adherence, retention, implementation procedures, and other design choices that determine whether future clinical studies are rigorous, efficient, and broadly informative.

A notable feature in the title is "Clinical Trial Optional," which signals that applicants may propose studies that do or do not meet the NIH definition of a clinical trial, depending on the project aims and methods. In practice, that means the program can accommodate a range of pilot-style efforts, from early feasibility or proof-of-concept intervention testing to research focused on trial methodology improvements, so long as the proposed work aligns with the stated intent of supporting intervention development and better trials for AD/ADRD and age-related cognitive decline.

Eligibility is broad and includes many organization types. Eligible applicants listed include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Historically Black Colleges and Universities (HBCUs); Hispanic-serving Institutions; Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; U.S. territories or possessions; and non-domestic (non-U.S.) entities, meaning foreign organizations may apply as well.

In terms of timing and funding parameters included in the provided data, the opportunity was created on 2022-12-23 and lists an original closing date of 2024-11-18. The award ceiling shown is $325,000. The posting notes "ExpectedAwards:" but does not provide a value in the supplied text, so the number of awards is not specified here.

Overall, this FOA is aimed at researchers who have a promising intervention concept or a trial-design improvement idea in the AD/ADRD or age-related cognitive decline space, but who need pilot-scale support to demonstrate feasibility, generate preliminary signals, and strengthen the evidence base needed to move into larger, more definitive studies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Studies for the Spectrum of Alzheimers Disease/Alzheimers Disease-Related Dementias and Age-Related Cognitive Decline (R61 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2022-12-23.
• Applicants must submit their applications by 2024-11-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $325,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 23 083

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: