Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) | PAR 16 364

Opportunity Information: Apply for PAR 16 364

The National Institutes of Health (NIH) funding opportunity titled "Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)" (Funding Opportunity Number PAR-16-364) supports large, definitive Phase III clinical trials aimed at testing promising interventions for cognitive decline associated with aging and across the full Alzheimer's disease (AD) continuum. The core purpose of this announcement is to encourage R01 grant applications that move beyond early feasibility and efficacy testing and instead focus on rigorous, late-stage trials designed to determine whether an intervention truly works in real-world, clinically meaningful terms. The targeted study populations include people who are pre-symptomatic (for example, individuals at risk who may not yet show clear symptoms), those with early or mild impairment, and individuals at more advanced stages of AD, as well as people experiencing age-related cognitive decline that may not meet criteria for Alzheimer's disease.

A key feature of the FOA is its openness to both pharmacological and non-pharmacological strategies. On the pharmacological side, this can include drug or biologic approaches intended to slow progression, delay onset, or improve cognitive or functional outcomes. On the non-pharmacological side, it can include interventions such as behavioral programs, cognitive training, lifestyle or multimodal risk-reduction approaches, caregiver- or systems-focused models of care, or other structured non-drug therapies, provided they are appropriate for Phase III testing and are framed as a well-controlled clinical trial. Because the announcement is specifically centered on Phase III trials, proposals are generally expected to be powered for definitive endpoints, to use strong trial designs (often multi-site), and to incorporate the operational elements needed for high-quality implementation, such as robust recruitment and retention plans, careful outcome selection, safety monitoring procedures, and clear statistical and data management strategies.

The award mechanism is the NIH R01 research project grant, and the activity area is health research, with CFDA number 93.866. The opportunity falls under the "Discretionary" category and uses the "Grant" funding instrument type. While the source information lists an award ceiling field without a stated amount and does not specify the expected number of awards in the excerpt provided, the emphasis on Phase III clinical trials implies a preference for well-justified budgets that match the scale and complexity of definitive clinical testing, including considerations like multi-site coordination, standardized intervention delivery, and adequate follow-up time to detect clinically meaningful change.

Eligibility is broad and includes many types of U.S. organizations and governmental entities, such as 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; public housing authorities and Indian housing authorities; and Native American tribal organizations that are not federally recognized tribal governments. The FOA also allows nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education in those categories), for-profit organizations (other than small businesses), and small businesses, along with an "Others" category. In addition, the announcement explicitly highlights additional eligible applicants, including 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; Indian/Native American Tribal Governments other than federally recognized entities; and even non-U.S. entities (foreign organizations), reflecting an intent to attract a wide range of capable trial sponsors and research teams.

From an administrative standpoint, the opportunity was created on October 6, 2015, and the original closing date listed is January 24, 2018. That closing date indicates this particular posting is historical, so anyone considering a similar application now would typically look for a reissued or successor FOA, or for current NIH Alzheimer-related clinical trial funding announcements that carry forward comparable goals. Even so, the essential thrust of this FOA is clear: NIH sought strong, trial-ready proposals that could definitively evaluate whether a well-supported intervention can prevent, delay, or treat cognitive decline and Alzheimer's disease across multiple disease stages, using Phase III standards of evidence and execution.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Phase III Clinical Trials for the Spectrum of Alzheimer's 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): 93.866.
• 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.

Apply for PAR 16 364

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