More Monitoring of Cognitive Change, Continued (M3C3) (U2C Clinical Trial Optional) | RFA AG 23 021

Opportunity Information: Apply for RFA AG 23 021

The More Monitoring of Cognitive Change, Continued (M3C3) opportunity (RFA-AG-23-021) is a National Institutes of Health funding announcement that supports the next phase of the Mobile Monitoring of Cognitive Change program, originally launched as the Mobile Toolbox (MTB) Project under RFA-AG-18-012. It is structured as a cooperative agreement (U2C), meaning NIH expects to have substantial programmatic involvement in shaping progress and deliverables rather than operating as a hands-off funder. While clinical trials are optional, the central purpose is not to fund a single stand-alone study, but to expand and mature a shared, reusable research infrastructure that many studies can rely on through at least fiscal year 2027.

At its core, the FOA is about making mobile, real-world measurement of cognitive change more powerful, more complete, and easier for the research community to use at scale. The existing MTB platform focused on mobile monitoring of cognition; this continuation explicitly pushes the platform beyond cognition alone by adding assessments of non-cognitive domains that can influence or modify cognitive performance. These additions include socioemotional and psychological functions, health states, and contextual factors, recognizing that day-to-day cognitive performance is shaped by mood, stress, sleep, symptoms, environment, and other real-life conditions that traditional clinic-based testing often misses. By broadening what the platform can measure, the program aims to support richer, more interpretable data streams that are better suited to understanding early changes relevant to Alzheimer’s disease (AD) and AD-related dementias (ADRD).

A major deliverable is practical implementation on the two dominant smartphone ecosystems: Android and iOS. The FOA calls for developing, or supporting the development of, mobile applications on both platforms so the tools are not limited to a single device type or user population. In addition, the expanded MTB must validate new tests and items used within the platform across a wide adult age range, roughly ages 20 to 85. That requirement reflects an emphasis on broad normative coverage and usability across adulthood, which is essential for detecting change over time and for comparing performance across different populations and study designs.

Beyond building assessments, the FOA is strongly oriented toward dissemination and long-term usability. The intent is that the platform will not only serve participants enrolled in the award-funded project itself, but will also be positioned as a shared resource for other NIH-funded studies. This includes enabling widespread sharing of the collected data and the test instruments, so that research groups can reuse measures, compare results across cohorts, and accelerate method development. The program also highlights the need for a shared data-processing backend, implying standardized pipelines for ingesting, processing, and managing temporally dense mobile data so that multiple studies can leverage common infrastructure rather than rebuilding it independently.

Another key theme is flexibility without fragmentation. The FOA envisions a platform that is widely disseminated and supported, but that can also accommodate study-specific measures when needed. In practice, that means the MTB ecosystem should be robust enough to support standardized core instruments while still letting individual studies add modules or specialized items, ideally without breaking comparability, security, or maintainability. The long-run goal is a mature, continuously updated platform that functions as a straightforward, low-friction way for researchers to collect real-time, real-world, extended monitoring data that are particularly relevant to early detection and characterization of AD/ADRD trajectories.

To make that sustainability realistic, the FOA also asks applicants to advance a future cost-recovery model. Rather than relying indefinitely on one-time development funding, the project is expected to move toward standardized subcontracting terms, conditions, and costs that allow the platform to stay maintained, updated, and available for broad use. This is essentially a plan for operational longevity: establishing clear, consistent ways other research teams can access and use the platform while contributing to the costs of keeping it secure, modern, and functional as phones and operating systems evolve.

In terms of administrative details, this is a discretionary health funding opportunity under CFDA 93.866, with an award ceiling listed at $4,800,000. The original closing date was October 20, 2022, and the opportunity was created July 11, 2022. Eligibility is broad and includes many government entities (state, county, city/township, special districts), public and private institutions of higher education, independent school districts, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and other applicants. The announcement also explicitly calls out a wide range of additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIS institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. entities and regional organizations, signaling an interest in broad participation and potentially diverse recruitment and deployment contexts.

Taken together, M3C3 is best understood as an infrastructure expansion and dissemination effort: it aims to strengthen a cross-study mobile measurement platform by adding non-cognitive and contextual assessments, ensuring full Android/iOS support, validating tools across ages 20-85, supporting shared backend processing and data/instrument sharing, and putting in place a sustainable model so the platform can remain current and widely usable for research on cognitive and functional change relevant to AD/ADRD through 2027 and beyond.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "More Monitoring of Cognitive Change, Continued (M3C3) (U2C Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2022-07-11.
• Applicants must submit their applications by 2022-10-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $4,800,000.00 in funding.
• 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 23 021

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