Towards Implementing Novel Training Methods to Enhance Cognition in Aging (U01 Clinical Trial Required) | RFA AG 18 031

Opportunity Information: Apply for RFA AG 18 031

The National Institutes of Health (NIH) is offering a cooperative agreement opportunity (U01) titled "Towards Implementing Novel Training Methods to Enhance Cognition in Aging (U01 Clinical Trial Required)" under Funding Opportunity Number RFA-AG-18-031 (CFDA 93.866). The main purpose of this announcement is to support planning awards that help research teams develop, refine, and fully finalize the protocols needed to launch well-powered cognitive training intervention trials. These future trials are expected to test whether cognitive training can remediate or prevent age-related cognitive decline and, importantly, whether it might also prevent or delay the onset of mild cognitive impairment (MCI) and dementia. Because the mechanism is a U01 cooperative agreement, awardees should expect substantial scientific involvement from NIH program staff compared to a typical investigator-initiated grant, and the opportunity explicitly requires a clinical trial component.

This funding is focused on the groundwork that must be completed before a large, definitive trial can be conducted. Applicants are being asked to use the planning period to sharpen the intervention and the study methods so that the later-stage trial is feasible, rigorous, and adequately justified. Planning activities can include collecting pilot data, testing feasibility, and refining the cognitive training protocol itself in a way that aligns with Stage I of the NIH Stage Model for behavioral intervention development. In practical terms, that means investigators should be tightening the specifics of the training approach (content, dose, delivery platform, adherence strategies, fidelity monitoring, and participant engagement) while also working out recruitment pipelines, retention plans, and operational details that commonly determine whether a large trial succeeds.

A major emphasis of the opportunity is that proposed trial designs must clearly justify how cognition will be assessed and how mechanisms of change will be explored. In other words, it is not enough to propose that cognition will improve; applicants need to make a strong case that their measurement plan is sensitive, valid, and appropriate for the targeted cognitive domains and population, and that the design can plausibly detect meaningful changes. Beyond behavioral outcomes, the NIH is encouraging applicants to include measures that probe why and how training might work. Appropriate candidate tools mentioned in the announcement include structural and functional neuroimaging and biomarker approaches, as long as they are tied to a coherent underlying model of change. The RFA specifically notes biomarker strategies such as cerebrospinal fluid (CSF) measures and blood-based biomarkers as acceptable options when scientifically justified, reinforcing the expectation that applicants connect intervention effects to brain and biological pathways rather than treating mechanistic measures as add-ons.

Eligible applicants span a wide range of U.S.-based organizations, reflecting NIH's intent to support diverse institutional settings and partnerships. Eligibility includes state, county, city or township, and special district governments; federally recognized Native American tribal governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities and Indian housing authorities; tribal organizations that are not 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; small businesses; and other eligible entities. The RFA also highlights additional eligible applicant types 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, regional organizations, eligible agencies of the federal government, tribal governments that are not federally recognized, and U.S. territories or possessions.

The geographic eligibility rules are specific: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicants. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. This structure allows U.S.-led projects to incorporate international sites, collaborations, or specialized capabilities when justified, while keeping the applicant organization based in the United States.

Administratively, the opportunity was created on February 14, 2018, with an original closing date of April 30, 2018. The sponsoring agency is NIH, and the activity category is Health. While the summary information provided does not list an award ceiling or the expected number of awards, the intent is clear: to fund planning work that results in finalized, trial-ready protocols for robust cognitive training studies in older adults, with careful attention to outcome measurement and mechanistic understanding so that subsequent large-scale trials can be launched on solid scientific and operational footing.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Towards Implementing Novel Training Methods to Enhance Cognition in Aging (U01 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 2018-02-14.
• Applicants must submit their applications by 2018-04-30. (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.

Apply for RFA AG 18 031

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