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

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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 Innovation Research (SBIR) program, funds research and development of innovative products, services, or technologies that advance the prevention, diagnosis, treatment, or care of Alzheimer's disease (AD) and AD-related dementias (ADRD). The program encourages commercialization of novel therapies, devices, diagnostics, and care solutions that can reduce the burden of AD/ADRD on individuals, families, and society.

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 disease monitoring.
• Treatment: Discovery and evaluation of drugs, biologics, delivery systems, and clinical trials for cognitive and behavioral symptoms, including disease-modifying therapies.
• Care: Technologies and systems to support independent living, in-home care, telecare, assistive robotics, and culturally appropriate care delivery.
• Tools: Platforms for drug screening, data analytics, and tools to support caregivers and healthcare systems.

Both clinical trial and non-clinical trial applications are accepted.

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Due Dates

• April 5, 2025: Renewal, Resubmission, Revision (as allowed)
• September 5, 2025: New applications and Renewal/Resubmission/Revision (as allowed)

All applications are due by 5:00 PM local time of the applicant organization. Standard NIH SBIR due dates apply; see the NIH due dates page for details.

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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 limits per NIH IC-specific guidelines
• Number of Awards: ~40 awards anticipated per year (subject to appropriations)

Applicants should consult the NIH SBIR budget waiver list to confirm eligibility for higher budgets.

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Eligibility

• Applicant Type: Only U.S. small business concerns (SBCs) are eligible.
  • Must be organized for profit, have a place of business in the U.S., and be majority U.S.-owned and controlled.
  • No more than 500 employees (including affiliates).
  • See the NIH SBIR eligibility criteria for details.
• Foreign Institutions: Not eligible. Foreign components may be allowed if justified.
• Principal Investigator: Must be primarily employed by the small business at the time of award and during the project.
• Multiple Applications: Allowed if scientifically distinct.

Note: New foreign disclosure requirements apply for applications submitted on or after September 5, 2023. See the FOA for details.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov or the NIH ASSIST system.
• Required Registrations: SAM, Grants.gov, eRA Commons, and SBA Company Registry (may take 6+ weeks).
• Application Guide: Follow the SF424 (R&R) SBIR/STTR Application Guide.
• Forms: Use FORMS-H or later.
• Data Management: All applicants must include a Data Management and Sharing Plan.
• SBIR Application Certification: Required for small businesses majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms.
• Page Limits: As per NIH SBIR guidelines.

Applicants are strongly encouraged to review the full funding opportunity announcement for detailed instructions and requirements.

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Additional Information

• Clinical Trials: Both clinical trial and non-clinical trial projects are eligible.
• Commercialization: Projects should have a clear path to commercialization and public health impact.
• Performance Benchmarks: Applicants with significant prior SBIR/STTR funding must meet transition and commercialization benchmarks.
• Security/Foreign Disclosure: New requirements for disclosure of foreign relationships and affiliations; non-compliance may result in denial of award.
• Data Rights: SBIR/STTR recipients may retain data rights for up to 20 years.

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External Links

• NIH Funder Home Page
• Full Funding Opportunity Announcement (PAS-22-196)
• NIH SBIR/STTR Program Overview
• NIH SBIR Budget Waiver Topics
• NIH Application Guide
• NIH Due Dates

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Contact Information

For additional contacts and details, see Section VII of the FOA.

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