Non-Invasive Neurostimulation in AD/ADRD (R01 Clinical Trial Optional) | PAR 19 298

Opportunity Information: Apply for PAR 19 298

The NIH funding opportunity PAR 19-298, titled "Non-Invasive Neurostimulation in AD/ADRD (R01 Clinical Trial Optional)," supports research projects that test or improve non-invasive brain stimulation and neuromodulation approaches for Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD). The main purpose is to move the field toward clinically useful interventions by either demonstrating early evidence of efficacy (for example, showing that a stimulation method can meaningfully improve symptoms or relevant biological markers) or by refining and optimizing these approaches so they are better suited for AD/ADRD populations. While clinical trials are not required, they are allowed under this announcement, which gives applicants flexibility to propose studies ranging from mechanistic and optimization work through early-stage efficacy testing in humans.

A key emphasis of the announcement is that the innovative centerpiece of the application should be neurostimulation or neuromodulation that is non-invasive. In practice, that typically means approaches that modulate brain activity without surgical implantation, such as transcranial magnetic stimulation (TMS), transcranial electrical stimulation methods (for example tDCS, tACS, or related waveforms), or other non-invasive stimulation strategies intended to influence neural circuits implicated in cognition, memory, behavior, or other AD/ADRD-relevant domains. The FOA is also open to multimodal or combination interventions, meaning applicants can pair neurostimulation with other components (such as cognitive training, behavioral interventions, rehabilitation-style approaches, imaging, electrophysiology, or pharmacologic co-interventions) as long as neurostimulation remains the primary focus and the major novel element being tested or refined. This structure encourages projects that not only ask whether stimulation helps, but also work out how, for whom, and under what parameters it may be most effective.

Because this is an R01 mechanism, the expectation is for a well-developed research plan with clear aims, rigorous methodology, and a level of scope appropriate for a standard NIH research project grant. Projects can be oriented toward establishing initial efficacy in AD/ADRD populations, which might include carefully designed pilot or early-stage clinical trials with clinical, cognitive, functional, or biomarker outcomes. Alternatively, proposals can focus on refinement work, such as determining optimal stimulation targets, dosing parameters, schedules, frequency bands, duration, individualization strategies, or identifying patient characteristics that predict response. Studies that incorporate objective measures of target engagement (for example neuroimaging or electrophysiological readouts) are often a natural fit for neuromodulation research because they can show whether the intervention is affecting the intended circuits and can help explain variability in outcomes.

Eligibility is broad, reflecting NIH’s intent to draw from many sectors and community contexts. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations not federally recognized as governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The FOA also explicitly calls out additional eligible groups and institution 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 and community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities. This wide eligibility list signals that NIH is open to proposals from academic labs, clinical centers, industry developers of stimulation devices, community-connected organizations, and cross-sector partnerships, including international collaborators where appropriate.

Administratively, the opportunity is categorized as a discretionary grant under the health activity category, administered by the National Institutes of Health, and linked to CFDA numbers 93.242 and 93.866. The original posting indicates a creation date of June 14, 2019, and lists an original closing date of September 7, 2022. The award ceiling and expected number of awards are not specified in the provided data, which usually means applicants need to consult the full FOA text and NIH budget guidance for any institute-specific limits, typical project sizes, and current submission cycles. Overall, the opportunity is designed to accelerate progress on non-invasive neuromodulation strategies that could become practical tools to treat or mitigate AD/ADRD symptoms, improve function, or potentially influence underlying disease-related circuitry, while also supporting the careful development work needed to make such interventions reliable, safe, and clinically meaningful for these patient populations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Non-Invasive Neurostimulation in AD/ADRD (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): 93.242, 93.866.
• This funding opportunity was created on 2019-06-14.
• Applicants must submit their applications by 2022-09-07. (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 19 298

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