DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award | HT942525ALSRPPCTA

Opportunity Information: Apply for HT942525ALSRPPCTA

The FY25 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award is a Department of Defense grant opportunity designed to push ALS clinical testing forward quickly, with an emphasis on trials that could meaningfully change how ALS is treated or managed. The program is aimed at getting well-justified interventions into patients in a practical, time-sensitive way rather than supporting earlier-stage discovery work. Funded studies are expected to be true clinical trials, and the overall intent is rapid implementation with a clear line of sight to clinical impact.

This award supports pilot clinical trials ranging from Phase 1 through small, early Phase 2 studies. Applications must fit into one of two required focus areas. The first is Biomarker-Driven Interventions, which centers on disease-modifying approaches where biomarkers are built into the trial to do specific jobs: help predict which participants are most likely to respond, show that the therapy is engaging its intended target, and demonstrate effects on the relevant biological pathway. The second focus area is Clinical Care, which targets practical improvements in clinical care and symptom management for people living with ALS. In other words, proposals can be about testing a therapy intended to slow or alter disease biology, or they can be about improving care delivery and symptom outcomes, as long as the work is structured as a clinical trial.

Several features are non-negotiable. First, the award funds must directly support a clinical trial; proposals that are not clinical trials are not responsive to the mechanism. Second, if the trial is testing a therapeutic intervention (including a drug, biologic, and/or device), the design must incorporate biomarkers that are specific to that intervention. This requirement goes beyond simply collecting exploratory biomarkers; the expectation is that biomarker measures are tied to the mechanism of action and are used to support participant selection, confirm target engagement, and/or provide pathway-relevant biological readouts. Third, every application must include a Community Collaboration Plan (referenced as Attachment 8 in the opportunity materials). This plan is meant to strengthen real-world impact by showing how the project will collaborate with and incorporate the perspectives of the ALS community, which can include patients, caregivers, advocacy organizations, and other stakeholders in trial design, recruitment, retention, communication, and dissemination of results.

The timeline expectations are also tight, consistent with the program's "rapid implementation" goal. The clinical trial is expected to begin no later than 12 months after the award date, or within 18 months for FDA-regulated studies. This effectively requires applicants to propose a trial that is operationally ready, with key elements such as regulatory strategy, site readiness, recruitment planning, and biomarker logistics developed enough to meet those start-up deadlines.

Administratively, this is a discretionary grant (Funding Instrument Type: Grant) in the science and technology/research and development category, with CFDA number 12.420. The sponsoring agency is the Department of the Army, administered through USAMRAA. Eligibility is listed as unrestricted, suggesting a broad range of applicants may apply (subject to the full solicitation rules). The opportunity number is HT942525ALSRPPCTA. The original application closing date is August 27, 2025, and the program anticipates making about two awards. The public listing does not specify an award ceiling amount.

• The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on 2025-04-18.
• Applicants must submit their applications by 2025-08-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: Unrestricted.

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