Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional) | PAS 19 316

Opportunity Information: Apply for PAS 19 316

The grant opportunity titled "Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)" is a National Institutes of Health (NIH) funding announcement from the National Institute on Aging (NIA) that supports small businesses through the Small Business Innovation Research (SBIR) program. The overall purpose is to push forward practical, innovation-driven research that can translate into real-world products or services aimed at preventing Alzheimer's disease and related dementias, improving treatment options, or strengthening how patients with AD/ADRD are cared for. In plain terms, this is meant to help companies move promising ideas out of the lab and toward tools, technologies, therapeutics, diagnostics, digital solutions, devices, or care-related innovations that could make a measurable difference for people affected by these conditions.

This is a discretionary grant opportunity (meaning it is competed and awarded based on merit review rather than by formula), and it uses the SBIR R43/R44 mechanism, which is NIH's standard phased approach for small business innovation funding. The R43 portion generally aligns with early-stage feasibility and proof-of-concept work, while the R44 portion typically supports further research and development as the project matures toward commercialization and broader deployment. The announcement is labeled "Clinical Trial Optional," which signals that applicants may propose studies that include clinical trials if appropriate for the product being developed, but a clinical trial is not required for every application. That flexibility matters because some AD/ADRD innovations are best validated through human studies, while others may need preclinical testing, usability studies, engineering validation, or other non-trial development steps before they are ready for formal clinical evaluation.

The eligible applicant pool is focused on small businesses, consistent with SBIR program rules. At the same time, the eligibility language makes clear limits around foreign involvement: non-U.S. entities (foreign institutions) cannot apply as the primary applicant, and non-U.S. components of U.S. organizations are also not eligible to apply as applicants. However, the announcement notes that "foreign components" may be allowed under NIH policy in some cases, which usually means a U.S.-based applicant could potentially include certain parts of the work being performed outside the United States if properly justified and permitted under the NIH Grants Policy Statement. The key practical takeaway is that the applying organization must be an eligible U.S. small business, and any international elements would need to fit within NIH's specific rules and approvals rather than functioning as the core applicant.

From an administrative standpoint, the opportunity number is PAS-19-316, and it sits in the health funding activity category under CFDA number 93.866, which is associated with aging and NIH/NIA-related programs. The opportunity was created on July 18, 2019, and the original closing date listed is September 6, 2022. The excerpt provided does not specify an award ceiling, nor does it list the expected number of awards, which often means applicants need to consult the full announcement for budget limits, project period constraints, and any institute-specific guidance on typical award sizes or the number of projects NIA expects to fund in a given cycle.

In terms of what NIA is trying to achieve, the emphasis is on "innovative products and/or services" that can advance progress across prevention, treatment, and patient care for AD/ADRD. That framing is broad by design and can include many types of deliverables, such as novel therapeutic approaches, biomarkers and diagnostic platforms, screening or monitoring technologies, software and digital health tools that support cognition or caregiving, devices that improve safety or independence, and care delivery innovations that enhance quality of life or reduce caregiver burden. What ties these possibilities together is the SBIR commercialization mindset: the project should not only answer scientific questions, but also move a development program toward a viable product or service that could realistically be used in clinical settings, in-home care, community health contexts, or other environments relevant to dementia care and management.

Overall, this FOA is a targeted SBIR pathway for small businesses working on Alzheimer's and related dementias, structured to support early feasibility through more advanced development, with the option to include clinical trials where they make sense. The official details that determine exact eligibility, budget rules, allowable foreign components, and submission requirements are contained in the full funding announcement, which applicants are expected to follow closely.

• 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) (R43/R44 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 19 316

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