Opportunity Information: Apply for PAS 18 188
The grant opportunity titled "Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)" is a federal research funding program run by the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services, specifically through the National Institute on Aging (NIA). It is designed to support small businesses that want to translate scientific ideas into practical, real-world products or services that could make a meaningful difference in the prevention, treatment, or care of people affected by Alzheimer's disease and related dementias. The program uses the Small Business Technology Transfer Research (STTR) mechanism, which generally means the applicant must be a small business working in formal collaboration with a nonprofit research institution such as a university or research hospital, with the goal of moving innovations out of the lab and closer to commercialization and real-world use.
This announcement uses the R41/R42 award structure, which is the typical two-phase STTR pathway. Phase I (R41) is usually meant to test early feasibility and demonstrate proof of concept, while Phase II (R42) supports more advanced research and development that builds on successful Phase I results. The "Clinical Trial Optional" wording signals that applicants are allowed, but not required, to propose clinical trial activities if those activities are appropriate for the technology being developed and if the project is ready for that stage. In practical terms, this makes the opportunity flexible: a company could propose preclinical validation work, development of a prototype, software development and testing, biomarker validation, or early-stage clinical evaluation, depending on what is scientifically justified and what would best accelerate the product or service toward use in the field.
The central purpose of the funding is to speed progress against Alzheimer's disease and Alzheimer's-disease-related dementias by encouraging innovation that can lead to deliverable tools. The FOA explicitly points toward projects that could help prevent disease onset, slow progression, improve diagnosis or monitoring, develop new therapies, and/or improve care for patients and support for caregivers. Because the emphasis is on "innovative products and/or services," the projects are expected to be more than basic science; they should be positioned as translational research and development efforts that could plausibly result in something deployable, such as a therapeutic candidate, diagnostic platform, digital health tool, device, laboratory assay, care model support technology, or other commercially relevant solution that addresses AD/ADRD needs.
Eligibility is limited to small businesses, reflecting the STTR program's focus on small-company innovation. The opportunity is categorized as a discretionary grant in the health funding area, with the associated CFDA number listed as 93.866. The announcement was created on November 28, 2017, and the original closing date was September 5, 2019. The listing indicates an expected number of awards of around 10, which suggests a competitive program with a limited number of funded projects. The award ceiling is shown as 0, which typically indicates that a single fixed cap is not provided in that summary field and that applicants should rely on the detailed FOA guidance and STTR budget rules for allowable funding levels by phase.
Overall, this funding opportunity is aimed at small businesses that have a strong research partnership and a credible development plan to move an Alzheimer’s or dementia-related innovation forward. Competitive applications would typically be expected to show clear significance to AD/ADRD, a technically sound development strategy suitable for an R41 or R42 stage, and a realistic pathway toward broader impact in healthcare, whether through commercialization, clinical adoption, or implementation in care settings.Apply for PAS 18 188
- The Department of Health and Human Services, 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 Nov 28, 2017.
- Applicants must submit their applications by Sep 05, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)".
Which federal agency runs this program?
This is a federal research funding program run by the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services, specifically through the National Institute on Aging (NIA).
What is the main purpose of this funding?
The purpose is to speed progress against Alzheimer's disease and Alzheimer's-disease-related dementias by supporting small businesses that are translating scientific ideas into practical, real-world products or services that could improve prevention, treatment, diagnosis/monitoring, or care for people affected by AD/ADRD.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the Small Business Technology Transfer Research (STTR) program's focus on small-company innovation.
What funding mechanism does this opportunity use?
This announcement uses the STTR mechanism (Small Business Technology Transfer Research), which generally requires a small business to work in formal collaboration with a nonprofit research institution such as a university or research hospital.
What does STTR collaboration typically mean for applicants?
It generally means the applicant is a small business that must have a formal partnership with a nonprofit research institution, with a goal of moving innovations out of the lab and closer to commercialization and real-world use.
What do R41 and R42 mean in this opportunity?
R41 and R42 describe the typical two-phase STTR pathway:
- Phase I (R41): usually focused on testing early feasibility and demonstrating proof of concept.
- Phase II (R42): supports more advanced research and development that builds on successful Phase I results.
Is a clinical trial required?
No. The opportunity is labeled "Clinical Trial Optional", which means applicants are allowed, but not required, to propose clinical trial activities if those activities are appropriate for the technology and the project is ready for that stage.
What kinds of projects fit under "Clinical Trial Optional"?
Because clinical trials are optional, the program can support a range of activities depending on what is scientifically justified, such as preclinical validation work, prototype development, software development and testing, biomarker validation, or early-stage clinical evaluation.
What types of solutions is NIH/NIA looking for?
The FOA emphasizes innovative products and/or services aimed at AD/ADRD needs. Examples mentioned or implied include deliverable tools such as therapeutic candidates, diagnostic platforms, digital health tools, devices, laboratory assays, care model support technology, or other commercially relevant solutions.
Is basic science research a fit for this program?
The emphasis is on translational research and development rather than basic science. Projects are expected to be positioned to plausibly result in something deployable in real-world settings (for example, in healthcare delivery, clinical adoption, or care settings).
What impact areas does the FOA specifically point to?
The FOA explicitly points toward projects that could:
- help prevent disease onset,
- slow progression,
- improve diagnosis or monitoring,
- develop new therapies, and/or
- improve care for patients and support for caregivers.
What is the CFDA number associated with this opportunity?
The associated CFDA number listed is 93.866.
How is this opportunity categorized?
It is categorized as a discretionary grant in the health funding area.
When was this announcement created and when did it close?
The announcement was created on November 28, 2017, and the original closing date was September 5, 2019.
How many awards were expected?
The listing indicates an expected number of awards of around 10, suggesting a competitive program with a limited number of funded projects.
Is there an award ceiling (maximum funding amount) listed?
The award ceiling is shown as 0 in the summary field, which typically indicates that a single fixed cap is not provided there. Applicants are expected to rely on the detailed FOA guidance and STTR budget rules for allowable funding levels by phase.
What makes an application more competitive based on the description provided?
Competitive applications would typically be expected to show:
- clear significance to AD/ADRD,
- a technically sound development strategy appropriate to an R41 or R42 stage, and
- a realistic pathway toward broader healthcare impact (for example, commercialization, clinical adoption, or implementation in care settings).
What is the overall intent of the STTR approach in this opportunity?
The intent is to support small businesses working with research institutions to help move innovations out of research environments and closer to real-world use, including commercialization and broader adoption in healthcare.
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