Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) | PAR 18 175

Opportunity Information: Apply for PAR 18 175

The funding opportunity titled "Pilot Clinical Trials for the Spectrum of Alzheimers Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)" (Funding Opportunity Number PAR 18 175) is a discretionary grant program from the National Institutes of Health (NIH). It is designed to move promising intervention ideas into early-stage human testing by supporting the development and implementation of Phase I or Phase II clinical trials. The focus is on interventions that may prevent, slow, or improve age-related cognitive decline and Alzheimers disease (AD), recognizing that AD is not a single uniform condition but a continuum that can begin years before symptoms and progress through mild to more severe stages.

At its core, this FOA is aimed at practical, pilot-scale trials that can generate the kind of early evidence needed to justify larger, definitive studies later on. Applicants are invited to test both pharmacological approaches (for example, drugs, biologics, or other medically administered agents) and non-pharmacological approaches (such as behavioral interventions, cognitive training, lifestyle programs, technology-assisted supports, care or service delivery models, or other non-drug strategies). The FOA explicitly welcomes studies involving participants across the full AD spectrum, from pre-symptomatic individuals who may be at risk or show biomarkers of disease, to people with more advanced impairment. It also includes people experiencing age-related cognitive decline that may not meet criteria for AD but still represents a meaningful and growing public health concern.

In addition to funding pilot trials of interventions themselves, the announcement encourages projects that strengthen the way these trials are designed and conducted. That means applicants can propose work that improves clinical trial methods for AD and cognitive decline, such as better recruitment and retention strategies, more sensitive or efficient outcome measures, improved staging and participant selection approaches, practical biomarker integration, innovative statistical designs for small early-phase trials, or methods that make studies more feasible in real-world settings. The emphasis on trial design and methods reflects how challenging AD research can be, particularly when trying to detect meaningful signals in early disease or when outcomes change slowly over time.

The funding mechanism is an NIH R01, and clinical trials are optional under this announcement, meaning the FOA allows proposals that include a clinical trial component (Phase I or II) as well as related work that advances trial readiness or methodology. The activity categories listed for the program are Education and Health, and the CFDA numbers associated with the opportunity are 93.361 and 93.866, indicating alignment with NIH programs in aging, neuroscience, and related research areas. The original closing date listed is July 26, 2018, and the opportunity was created on November 1, 2017. An award ceiling is not specified in the provided source data, and the expected number of awards is not listed, which is common for NIH announcements where actual award numbers and budgets depend on application volume, scientific merit, and available appropriations.

Eligibility is broad and intentionally inclusive, reflecting NIH interest in drawing strong proposals from many types of organizations and communities. Eligible applicants 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; Native American tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those specific nonprofit categories); for-profit organizations other than small businesses; small businesses; and other categories. The FOA also highlights additional eligible applicant types, 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, and even non-U.S. entities (foreign organizations). This broad eligibility aligns with the reality that meaningful AD and cognitive decline research often requires diverse recruitment networks, community partnerships, and multi-site capacity, and it encourages participation from institutions serving populations that have historically been underrepresented in clinical research.

Overall, PAR 18 175 is best understood as an NIH pathway for testing and refining early-stage intervention ideas in humans while also improving the clinical trial toolkit for Alzheimers disease and age-related cognitive decline. It prioritizes studies that can realistically be executed as Phase I or II trials, generate actionable evidence, and strengthen future trial efficiency and rigor, with the long-term goal of accelerating progress toward effective treatments and prevention strategies across the entire course of disease.

• 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 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.361, 93.866.
• This funding opportunity was created on 2017-11-01.
• 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 18 175

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