Low Cost Detection of Cognitive Decline in Clinical Settings (R61/R33 Clinical Trial Required) | RFA AG 20 050

Opportunity Information: Apply for RFA AG 20 050

The National Institutes of Health funding opportunity titled "Low Cost Detection of Cognitive Decline in Clinical Settings (R61/R33 Clinical Trial Required)" (RFA-AG-20-050; CFDA 93.866) supports projects aimed at improving how cognitive decline is identified and acted on in everyday clinical care. The core idea is to move beyond research-only assessments by developing or refining practical, low-cost cognitive screening instruments that can be used in real clinical settings, then integrating those tools into electronic health record (EHR) workflows so clinicians can receive usable information and guidance at the point of care. A key emphasis is not just detecting possible impairment, but translating screening results into clinically meaningful care recommendations, which can include next steps for evaluation, referrals, support services, or other care planning actions appropriate for patients showing signs of cognitive decline.

The FOA uses a phased R61/R33 structure. The R61 phase is described as a pilot or early-stage period (Stage I in the announcement language) where investigators are expected to develop and validate cognitive screening or assessment tools in clinical settings. This phase is also intended to support work that makes the tools practical for real-world adoption, including translating the assessments into EHR-compatible formats and designing scalable, tailored interventions that help patients and clinical practices overcome barriers to uptake. In other words, the pilot stage is not only about psychometrics or accuracy; it is also about making the approach feasible in routine care, mindful of time, staffing, cost, and workflow constraints that typically limit cognitive screening in busy practices.

If the R61 phase meets predefined milestones, projects may transition to the R33 phase (labeled Stage IV in the announcement) to carry out implementation-focused pragmatic trials. This later stage is meant to test how well the tools and their EHR integration work under real-world conditions, including whether they actually improve clinical decision-making, care recommendations, and downstream patient-centered outcomes when used by clinicians in typical healthcare environments. The requirement that a clinical trial be included signals that the supported work must go beyond concept development and include prospective testing in humans, consistent with NIH definitions of clinical trials.

Health disparities are a required focus for all applicants. That means proposals need to explicitly address inequities in detection, diagnosis, access to evaluation, and care pathways for cognitive decline across populations that have been historically underserved or experience disproportionate burden. In practical terms, strong applications would be expected to consider differences in language, education, culture, socioeconomic factors, geography, comorbidities, and healthcare access that can affect both screening validity and the likelihood that patients receive appropriate follow-up. The disparities requirement also implies that validation and implementation strategies should be designed so the resulting tools do not worsen inequities, for example by embedding bias in scoring, using norms that do not generalize, or relying on resources only available in well-resourced systems.

A notable feature of this FOA is that preliminary data are not required. This lowers the barrier for teams with strong, well-justified ideas that may be earlier in development, particularly if they can propose a credible R61 plan with clear validation steps, integration into clinical workflows, and milestone-driven progression to pragmatic testing. At the same time, because the mechanism is milestone-based and designed to transition to pragmatic trials, applicants still need to present a rigorous plan for development, validation, EHR translation, and implementation evaluation.

Eligibility is broad and includes a wide range of domestic organizations: state, county, city, township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses, among others. The FOA also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Indian/Native American Tribal Governments (other than federally recognized), regional organizations, Tribally Controlled Colleges and Universities (TCCUs), and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible as applicant components. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which generally means discrete portions of the project may be conducted outside the U.S. when appropriately justified and compliant with NIH policy.

Administratively, this is an NIH discretionary grant in the health activity category. The original closing date listed for the opportunity is January 30, 2020, and the creation date is September 27, 2019. The public summary provided does not specify an award ceiling or expected number of awards, which suggests those details would need to be confirmed in the full FOA or related NIH notices. Overall, the opportunity is positioned for teams that can bring together clinical researchers, cognitive assessment expertise, implementation science, health equity approaches, and health informatics/EHR integration so that cognitive screening becomes both accurate and actionable in routine care, particularly in settings and populations where barriers and disparities are most pronounced.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Low Cost Detection of Cognitive Decline in Clinical Settings (R61/R33 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 2019-09-27.
• Applicants must submit their applications by 2020-01-30. (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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