Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01) | PAR 16 365

Opportunity Information: Apply for PAR 16 365

Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01) (Funding Opportunity Number PAR 16 365) is a National Institutes of Health (NIH) discretionary grant opportunity designed to move promising interventions into early-stage human testing for cognitive aging and Alzheimers disease. The main purpose of the announcement is to support the development and conduct of Phase I or Phase II clinical trials that evaluate both pharmacological approaches (such as drugs or biologics) and non-pharmacological approaches (such as behavioral, lifestyle, cognitive, device-based, or other non-drug strategies). A key emphasis is on covering the full disease and risk spectrum, meaning studies may focus on people with age-related cognitive decline as well as individuals with Alzheimers disease ranging from pre-symptomatic stages through more advanced clinical stages. In addition to funding actual pilot trials, the announcement also aims to stimulate research that improves how these trials are designed and run, encouraging innovations that strengthen trial methodology, efficiency, and overall interpretability.

The scope is intentionally broad in terms of who can be studied and what can be tested, as long as the proposed work fits within early-phase clinical trial goals and addresses cognitive decline or Alzheimers disease. Projects are expected to be practical and implementation-focused, reflecting the intent to generate the kind of early clinical evidence that can justify larger, later-phase trials or help eliminate ineffective strategies before major resources are invested. Because the FOA explicitly mentions enhancing trial design and methods, applications can also center on improving key aspects of clinical trials in this area, such as recruitment and retention strategies, outcome measurement, biomarkers and staging approaches, adherence monitoring, feasibility testing, and other methodological elements that can increase the quality and success rate of studies across the AD and cognitive decline landscape.

Eligibility is expansive and includes many types of organizations that can credibly conduct or support clinical trial work. Standard eligible applicants listed include state, county, city or 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; public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education when categorized that way); for-profit organizations (other than small businesses) as well as small businesses; and other applicant types. The FOA also highlights additional eligible applicant categories that NIH wants to encourage or explicitly include, such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects the reality that effective Alzheimers and cognitive aging research often depends on diverse clinical sites, community partnerships, and access to varied participant populations.

From the funding mechanics side, the opportunity uses the NIH R01 grant mechanism and is categorized as a grant under a discretionary program. The activity area is listed under education and health, and the associated CFDA numbers are 93.361 and 93.866. The opportunity record shows an original closing date of January 24, 2018, with a creation date of October 6, 2015. An award ceiling is not specified in the provided source data, and the number of expected awards is not shown, which often means applicants should rely on the full FOA text and NIH institute/center guidance for budget expectations, allowable costs, and the likely scale of awards.

In practical terms, the FOA is aimed at investigators and organizations ready to translate promising ideas into structured early clinical testing in humans, whether that is testing a new therapy, repurposing an existing one, or evaluating a non-drug intervention that could slow decline, improve cognitive function, delay symptom onset, or otherwise alter clinically meaningful outcomes. It also supports work that makes these trials better, faster, and more reliable, which is particularly important in Alzheimers disease research where long timelines, heterogeneous participants, and complex endpoints can make early-phase studies challenging.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.361, 93.866.
• This funding opportunity was created on 2015-10-06.
• Applicants must submit their applications by 2018-01-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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