DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

The Department of the Army Medical Command (CDMRP) is soliciting applications for the Fiscal Year 2026 Amyotrophic Lateral Sclerosis Research Program Pilot Clinical Trial Award, with a full application deadline of September 30, 2026. Eligible applicants are unrestricted and include extramural and intramural U.S. Department of War organizations, foreign and domestic for-profit and nonprofit organizations, and public or private entities; independent investigators may serve as Principal Investigator regardless of ethnicity, nationality, or citizenship, but may be named on no more than three FY26 ALSRP applications across all award mechanisms. Cost sharing is not required. The program expects to allot approximately $5.6 million to fund roughly two applications, with a total cost cap of $2.8 million per award and a maximum performance period of three years.

Funding must support a clinical trial addressing one of two focus areas: Biomarker-Driven Interventions (disease-modifying interventions with mechanism-specific biomarkers to predict participant response and target engagement) or Clinical Care (improving aspects of clinical care and symptom management). Projects may range from phase 1 to small-scale phase 2 trials. The clinical trial must begin no later than 12 months after award or 18 months for FDA-regulated studies. Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into trial design. All applications must incorporate mandatory community collaboration with people living with ALS, family members, care partners, or community-based organizations; include a detailed Regulatory Strategy plan outlining the approach for obtaining regulatory approvals; and provide a separate Transition Plan describing advancement to the next development phase. If required, IND or IDE applications must be submitted to the FDA by the application submission deadline. Direct costs may support travel for multi-institutional collaborations, one investigator's travel to two scientific meetings per year, and research subject compensation with trial-related reimbursements.

Pre-applications are due June 24, 2026, with invitations to submit full applications by August 3, 2026. Peer review is scheduled for November 2026 and programmatic review for January 2027, with awards anticipated by September 30, 2027. The assistance listing is 12.420 (Military Medical Research and Development).