Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required) | PAR 18 028

Opportunity Information: Apply for PAR 18 028

The funding opportunity titled "Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required)" (Funding Opportunity Number PAR 18-028) is a National Institutes of Health (NIH) grant program designed to support large, definitive Phase III clinical trials. The focus is on testing promising interventions intended to prevent, slow, or treat age-related cognitive decline and conditions across the full Alzheimer's disease (AD) continuum, ranging from pre-symptomatic individuals to those with more advanced disease. In practical terms, the FOA is looking for applications that are ready to move beyond early-stage feasibility work and into rigorous, confirmatory trials that can provide clear evidence of clinical benefit (or lack of benefit) at a scale appropriate for Phase III research.

The program supports both pharmacological and non-pharmacological interventions. Pharmacological interventions generally include drugs and biologics, while non-pharmacological approaches can include behavioral interventions, cognitive training, lifestyle or exercise programs, caregiver or care-delivery models, technology-enabled supports, and other structured therapeutic strategies. The intent is to encourage well-designed trials that can meaningfully inform clinical practice and public health approaches, rather than exploratory pilots. Because the FOA specifies "Clinical Trial Required," a proposed study is expected to meet NIH's definition of a clinical trial and to be designed and conducted as a Phase III trial with appropriate methodological rigor, such as strong randomization procedures where applicable, adequate sample size and power, clearly defined outcomes, and robust monitoring and oversight.

The funding mechanism is the NIH R01, which is a standard research project grant. R01 awards are typically used to support discrete, specified projects led by a principal investigator (or multiple PIs) and can accommodate complex, multi-site clinical trial structures when well justified. The Funding Instrument Type is listed as a grant, and the Funding Activity Category is health, with CFDA number 93.866. While the source snippet does not provide an award ceiling or the number of expected awards, the framing suggests NIH is emphasizing the public health urgency and the need for late-stage trials capable of producing actionable evidence across Alzheimer's-related conditions and age-associated cognitive decline.

Eligibility is broad and includes a wide range of domestic and international institutions and organizations. Eligible applicants include state, county, and local governments; 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and 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 groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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 non-U.S. (foreign) organizations. This wide eligibility reflects an interest in drawing on diverse research settings, populations, and operational capacities, which can be especially important for Phase III recruitment, generalizability, and implementation planning.

Key administrative details from the listing include an original closing date of July 26, 2018, and a creation date of October 30, 2017. The agency is NIH, and the opportunity is categorized as discretionary. Overall, the FOA is aimed at accelerating high-quality, late-stage clinical testing of interventions across the AD spectrum and age-related cognitive decline, with the expectation that funded projects will be capable of delivering definitive conclusions that can guide future regulatory, clinical, and health-system decisions.

• 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 Clinical Trial Required)" 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 2017-10-30.
• Applicants must submit their applications by 2018-07-26. (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 18 028

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