Funder: National Institutes of Health
Due Dates: April 5, 2025 (New/Renewal/Resubmission/Revision) | September 5, 2025 (New/Renewal/Resubmission/Revision)
Funding Amounts: Phase I: up to $500,000 (2 years); Phase II: up to $2.5M (3 years) for approved topics; typical ceiling $1,838,436
Summary: Supports small business-led research to develop innovative products, services, or technologies for the prevention, diagnosis, treatment, or care of Alzheimer's disease and related dementias.
Key Information: Updated March 31, 2025: Aligns with new NIH priorities—review full FOA for changes; clinical trials are optional.
Description
This opportunity, offered by the National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) under the NIH Small Business Technology Transfer (STTR) program, funds research and development of innovative products, services, or technologies with the potential to advance prevention, diagnosis, treatment, or care for Alzheimer's disease (AD) and AD-related dementias (ADRD). The program encourages commercialization of novel therapies, devices, diagnostics, and care solutions, including clinical trials.
Research areas of interest include, but are not limited to:
- Prevention: Interventions (behavioral, pharmacological, nutritional, etc.) to prevent or remediate neurodegenerative changes.
- Diagnosis: Development of sensitive, specific, and standardized diagnostic tools, biomarkers, imaging, biosensors, and machine learning tools for early detection and monitoring.
- Treatment: Discovery and evaluation of drugs, biologics, or other interventions to treat or slow AD/ADRD progression, including clinical trials.
- Care: Technologies and systems to support independent living, improve care delivery, assistive robotics, telecare, and tools to reduce caregiver burden.
- Tools: Analytical platforms, training materials, and technology to support research, care, and cost modeling.
Applicants may propose projects at any stage (Phase I, Phase II, or Fast-Track), and clinical trials are optional.
Due Dates
- April 5, 2025: New, Renewal, Resubmission, and Revision applications
- September 5, 2025: New, Renewal, Resubmission, and Revision applications
All applications are due by 5:00 PM local time of the applicant organization. Standard NIH due dates apply; see the NIH due dates page for details.
Funding Amount
- Phase I: Up to $500,000 total costs for up to 2 years (for AD/ADRD topics with SBA waiver; otherwise, $275,766 standard cap)
- Phase II: Up to $2,500,000 total costs for up to 3 years (for AD/ADRD topics with SBA waiver; otherwise, $1,838,436 standard cap)
- Phase IIB: Budget per NIH IC-specific limitations
The number of awards and total funding depend on annual appropriations. NIA anticipates funding approximately 10 awards per year.
Eligibility
- Eligible Applicants: Only United States small business concerns (SBCs) are eligible. SBCs must be:
- Organized for profit, with a place of business in the U.S.
- More than 50% owned and controlled by U.S. citizens or permanent residents (see FOA for detailed ownership rules).
- Fewer than 500 employees (including affiliates).
- Able to partner with a U.S. non-profit research institution (required for STTR).
- Foreign Institutions: Not eligible. Foreign components may be allowed if justified.
- PD/PI Requirements: Must have a formal appointment with the SBC or the partnering research institution and commit at least 10% effort.
- Performance Benchmarks: Applicants with significant prior SBIR/STTR funding must meet transition and commercialization benchmarks (see FOA for details).
Application Process
- Submission: Applications must be submitted electronically via Grants.gov or the NIH ASSIST system.
- Required Registrations: SAM, eRA Commons, Grants.gov, and SBA Company Registry registrations are required prior to submission.
- Application Guide: Follow the SF424 (R&R) SBIR/STTR Application Guide and the specific instructions in the FOA.
- Data Management: All applicants must include a Data Management and Sharing Plan.
- Page Limits: Standard NIH SBIR/STTR page limits apply.
- Review Criteria: Applications are evaluated for significance, innovation, approach, investigator(s), and environment, as well as commercial potential and, if applicable, clinical trial design.
Additional Information
- Clinical Trials: Optional; both clinical and non-clinical projects are eligible.
- Updated Priorities: As of March 31, 2025, the FOA has been updated to align with new NIH priorities—review the full announcement for changes.
- Security and Foreign Disclosure: Enhanced disclosure requirements regarding foreign relationships and security risks apply for applications submitted on or after September 5, 2023.
- Cost Sharing: Not required.
- Multiple Applications: Allowed if scientifically distinct.
External Links
Contact Information
For additional contacts and details, see Section VII. Agency Contacts in the FOA.