Validating digital health technologies for monitoring biomarkers in ADRD clinical trials (R61/R33 - Clinical Trials Optional) | RFA NS 24 026

Opportunity Information: Apply for RFA NS 24 026

This NIH funding opportunity (RFA NS 24-026) supports projects that bring academic researchers and wearable-device companies together to validate digital health technologies (DHTs) as "digital monitoring biomarkers" for Alzheimer’s disease and related dementias (ADRD) in the context of clinical trials. The core idea is to move beyond using wearables only for general wellness or passive tracking and instead generate the kind of rigorous evidence needed for these devices and their algorithms to produce measures that are accurate, clinically meaningful, and suitable for inclusion as monitoring endpoints in future ADRD trials.

A central requirement is that applicants work with diverse participant groups and include at least two or more early-stage, clinically diagnosed ADRD populations. In practice, that means the technology and its algorithms cannot be tuned only to a narrow demographic or a single diagnosis; they must perform well across real-world variability in age, race and ethnicity, socioeconomic context, comorbidities, and disease presentations. The opportunity emphasizes community engagement and recruitment strategies that can realistically achieve that diversity, recognizing that recruitment barriers are often a major reason why promising digital measures fail to generalize.

On the technical and clinical validation side, the studies must demonstrate that the wearable-derived digital markers can accurately differentiate clinically meaningful features. The announcement gives sleep staging as an example, but the broader expectation is that the measures extracted from the device signals (for example, activity, sleep, gait, physiologic signals) can be shown to reliably map onto interpretable features that matter for patients and clinicians. Beyond cross-sectional accuracy, applicants must also show longitudinal value: the wearable features should track over time in a way that relates to quality-of-life metrics. In other words, it is not enough to prove a measure can be computed; the project must demonstrate that changes in the digital markers meaningfully correspond to changes in patient-relevant outcomes.

Another major requirement is biological and cognitive grounding. The studies should establish relationships between the DHT-derived features and one or more analytically validated ADRD biomarkers, along with standard cognitive assessments. This is meant to connect what the device is capturing to underlying disease biology (pathophysiology) or to clearly defined cognitive concepts, rather than leaving the digital measure as a "black box" signal. By tying DHT outputs to established biomarkers and cognitive tests, the program aims to strengthen confidence that the digital measures reflect clinically and biologically relevant aspects of ADRD, which is essential if they are to be used as monitoring biomarkers in trials.

The funding uses a phased, five-year R61/R33 structure. The first phase (R61, up to two years) functions as a startup and optimization period, focused on community engagement, building recruitment pipelines for diverse cohorts, and running pilot studies to refine data collection and improve or calibrate algorithms. The second phase (R33, up to three years) is the full validation period, where the refined technology and algorithms are tested more rigorously to demonstrate performance, reliability, and the required longitudinal and biomarker-linked relationships. This structure is designed to reduce risk by ensuring that recruitment feasibility, participant acceptability, and algorithm readiness are addressed before moving into a larger validation effort.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The opportunity also explicitly highlights a range of other eligible applicant categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, AANAPISISs, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign organizations and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components (as defined by NIH policy) may be allowed, which typically means discrete parts of a project can occur abroad under specific NIH rules even when the applicant organization itself must be U.S.-based.

Administrative details include that the funding instrument is a grant under NIH, categorized as a discretionary opportunity in the health area, with CFDA numbers 93.853 and 93.866. The original closing date listed is 2023-11-17, and the stated award ceiling is $1,000,000. The overall end goal NIH is aiming for is clear: generate convincing, trial-ready evidence that certain wearable-based digital measures can serve as monitoring biomarkers in ADRD clinical trials, helping researchers follow disease-related changes over time in a way that is scalable, less burdensome than frequent clinic visits, and more reflective of day-to-day function.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Validating digital health technologies for monitoring biomarkers in ADRD clinical trials (R61/R33 - Clinical Trials Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
• This funding opportunity was created on 2023-08-01.
• Applicants must submit their applications by 2023-11-17. (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 $1,000,000.00 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 NS 24 026

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