Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional) | PAS 19 317

Opportunity Information: Apply for PAS 19 317

This grant opportunity, titled "Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)," is a National Institutes of Health (NIH) funding announcement from the National Institute on Aging (NIA). It is issued under the Small Business Technology Transfer (STTR) program and is designed to support small businesses working in partnership with a research institution to move promising, innovation-driven research toward real-world products or services. The overall goal is to speed up progress in preventing and treating Alzheimer's disease and related dementias, as well as improving care and treatment options for people living with AD/ADRD.

The funding mechanism uses the R41/R42 STTR structure, which typically supports a phased pathway from early proof-of-concept work to more advanced development. In practical terms, this means the opportunity is meant for projects that can start by demonstrating feasibility and then build toward development and validation of a technology, tool, or service with a credible path toward use in clinical, caregiving, or health system settings. The announcement is also labeled "Clinical Trial Optional," meaning applicants may propose studies that include clinical trials if appropriate for their technology or service, but they are not required to do so. That flexibility is important for AD/ADRD innovation because some projects are best advanced through clinical testing, while others may focus on preclinical validation, software development, device prototyping, biomarker assay optimization, care delivery tools, or other non-trial development activities.

The intended applicants are small businesses. As an STTR opportunity, the program generally expects a formal collaboration between the small business and a nonprofit research institution (such as a university or research hospital), with each party contributing meaningfully to the research and development effort. The emphasis is on "innovative products and/or services," which can include therapeutics, diagnostics, devices, digital health solutions, data platforms, screening tools, caregiving supports, or other practical innovations that address unmet needs in AD/ADRD prevention, treatment, disease management, and patient care. The scope is broad on purpose, reflecting the complexity of Alzheimer's and related dementias and the many points where innovation can improve outcomes, from early detection and risk reduction through to daily care and symptom management.

Eligibility rules are clearly focused on U.S.-based applicants. Non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply as applicant entities. However, the announcement notes that "foreign components" may be allowed as defined under the NIH Grants Policy Statement, which typically means certain project elements may be conducted outside the U.S. if they are well-justified, unique, and meet NIH policy requirements, but the applicant organization itself must still be an eligible U.S. small business. Because the line between an ineligible non-domestic entity and an allowable foreign component can be technical, applicants are expected to consult the full funding announcement and NIH policy language to confirm what is permitted for their specific project plan.

From an administrative standpoint, this is a discretionary grant opportunity in the health funding category, listed under CFDA number 93.866 and administered by NIH/NIA. The funding opportunity number is PAS-19-317, and it was created on July 18, 2019. The original closing date listed is September 6, 2022. The source data does not provide an award ceiling amount or an expected number of awards, which usually means applicants need to refer to the full FOA text for budget limits, typical award sizes, project period expectations, and any institute-specific caps or guidance.

Overall, this FOA is aimed at small business-led translational research that has a plausible route to impact in the Alzheimer's and ADRD space. The NIA is effectively signaling that it wants to fund practical, development-oriented innovation that can move beyond basic research and toward tools, interventions, and services that could ultimately be used to prevent disease, treat or slow progression, improve diagnosis or monitoring, or strengthen the quality of care and support for patients and caregivers.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 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 2019-07-18.
• Applicants must submit their applications by 2022-09-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAS 19 317

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