DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award

The Department of Defense, through its Congressionally Directed Medical Research Programs (CDMRP), has released the Fiscal Year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA), aimed at advancing impactful ALS interventions. Managed by the U.S. Army Medical Research and Development Command (USAMRDC) and administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA), this grant seeks to accelerate clinical research focused on ALS treatment and symptom management. The ALSRP, initiated in 2007, has received over $269 million in appropriations through FY24, with $40 million allocated for FY25. The primary objective of this funding opportunity is to support rapid implementation of clinical trials (Phase 1 through small-scale Phase 2) with the potential for meaningful advances in ALS care. Applicants must select one of two focus areas: Biomarker-Driven Interventions or Clinical Care. Biomarker-driven projects should utilize mechanism-specific biomarkers to guide and evaluate interventions. Clinical care-focused projects should aim to enhance patient care and symptom management. All proposed trials must integrate a Community Collaboration Plan, involving people living with ALS, caregivers, or community organizations in the research planning and execution phases to ensure relevance and impact. Approximately $5.6 million is available under this mechanism, with up to two awards anticipated, each capped at $2.8 million in total costs over a maximum performance period of three years. The funding is strictly for clinical trials and must support efforts leading to meaningful safety, efficacy, or outcome assessments. FDA-regulated trials must begin within 18 months of the award date, and all trials must commence within 12 months otherwise. The funding expires on September 30, 2031, with all awards issued no later than September 30, 2026. Eligible applicants include both intramural and extramural organizations, such as academic institutions, non-profit and for-profit entities, and government organizations (excluding the Department of Defense for extramural applicants). Independent investigators at any career level may serve as Principal Investigator, provided they are affiliated with an eligible organization. Cost sharing is not a requirement. The application process consists of two steps: a pre-application due by June 6, 2025, submitted via eBRAP, followed by an invitation-only full application, due by August 27, 2025, via Grants.gov or eBRAP depending on the organization type. The application must include a range of detailed attachments, including project narratives, recruitment plans, regulatory strategies, and impact statements. Applications will be reviewed based on scientific merit, feasibility, impact, and programmatic alignment, with peer and programmatic review tiers applied. Support is available through the eBRAP Help Desk and Grants.gov Contact Center. Key review dates include peer review in October 2025 and programmatic review in December 2025. Funding announcements will be posted within six weeks after the programmatic review. Additional compliance requirements apply for post-award activities, including reporting, adherence to data sharing policies, and community engagement throughout the project lifecycle.