DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award

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Description

This opportunity from the Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) supports research on developing and/or validating clinical outcomes and biomarkers to enhance clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects may focus on a specific therapy, therapeutic class, or ALS subtype and must address one or both of the following focus areas:

• Clinical Biomarkers: Identification, development, and/or validation of biomarkers (e.g., susceptibility/risk, diagnostic, prognostic, monitoring, predictive, response, safety).
• Clinical Outcomes: Identification, development, and/or validation of clinician-, observer-, patient-reported, or performance outcome measures, including optimization of those already in use.

Digital health measures (e.g., wearables, smartphone sensors, imaging, voice/video) are encouraged. Projects involving prospective biospecimen collection or participant enrollment must include a Community Collaboration (e.g., partnership with people living with ALS, caregivers, or advocacy organizations).

Clinical trials are not permitted under this award mechanism, but observational and non-interventional clinical research is allowed.

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Due Dates

• Pre-application deadline: June 6, 2025 (5:00 p.m. ET)
• Invitation to submit full application: July 10, 2025
• Full application deadline: August 27, 2025 (11:59 p.m. ET)
• End of application verification period: September 3, 2025 (5:00 p.m. ET)
• Peer review: October 2025
• Programmatic review: December 2025

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Funding Amount

• Total program funding: ~$6,300,000
• Expected number of awards: Approximately 6
• Maximum funding per award: $1,000,000 total costs (direct + indirect) over up to 3 years
• No cost sharing or matching required

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Eligibility

• Organizations: Open to extramural (academic, non-profit, for-profit, public, private, foreign, and domestic) and intramural DOD organizations.
• Principal Investigator: Independent investigators at all career levels; no citizenship or nationality restrictions.
• Awards are made to organizations, not individuals.
• Clinical trials are not allowed. Only clinical research (observational, non-interventional) is permitted.

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Application Process

Step 1: Pre-Application

• Submit via eBRAP.
• Components: Preproposal narrative (3 pages), references, key personnel biosketches, and supporting documents.
• Deadline: June 6, 2025

Step 2: Full Application (by invitation only)

• Submit via Grants.gov (extramural) or eBRAP (intramural DOD).
• Components include:
  • Project narrative (12 pages)
  • Technical and lay abstracts
  • Statement of work
  • Clinical impact and population statements
  • Data/resource sharing plan
  • Community Collaboration Plan (if applicable)
  • Budget and justification
  • Letters of support, biosketches, and other required attachments
• Deadline: August 27, 2025

All applicants must have active registrations in SAM.gov, eBRAP, and Grants.gov.

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Additional Information

• Community Collaboration: Required for studies with prospective biospecimen collection or participant enrollment. Collaboration can be with individuals with ALS, caregivers, advocacy groups, or advisory boards.
• Data Sharing: Strong plans for sharing data and resources are required. Use of publicly available ALS repositories is encouraged.
• Focus on Impact: Projects should advance biomarkers or outcomes that can improve clinical trial design or patient care, with attention to military and veteran populations where relevant.
• No clinical trials: Interventional studies are not allowed under this mechanism.
• Review Process: Two stages—peer review for scientific merit, followed by programmatic review for alignment with ALSRP priorities.

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External Links

• Dept. of the Army -- USAMRAA (CDMRP)
• Full opportunity details at Grants.gov
• ALSRP Program Page
• eBRAP Submission Portal
• Program Announcement (PDF)

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Contact Information

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