DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

Defense Health Agency Contracting Activity - DHACAAmount not specifiedClosed

Researchers Schools & universities Broad eligibility

Deadline: Sep 30, 2026
Posted: May 4, 2026
Award amount: Amount not specified
Focus areas: Science and Technology and other Research and Development

In plain English

This Department of War (Defense Health Agency) ALS Research Program Pilot Clinical Trial Award supports rapid implementation of phase 1 to small-scale phase 2 trials affecting ALS treatment or management. Eligibility is described as unrestricted (open to any entity type), subject to clarifications. Applications must address biomarker-driven interventions or clinical care, incorporate community collaboration, and include a regulatory strategy and transition plan. No specific award amount is stated.

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Who can apply

Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

About this grant

Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of amyotrophic lateral sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials. Applications must address one of the following focus areas: · Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific biomarkers to predict which clinical trial participants are likely to respond, demonstrate target engagement, and effects on the intended biological pathway. · Clinical Care: Improving aspects of clinical care and symptom management for ALS. Distinctive Features: Funding from this award mechanism must support a clinical trial. The clinical trial should begin no later than 12 months after the award date or 18 months for U.S. Food and Drug Administration (FDA)-regulated studies. Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design. All pre-applications and applications are required to incorporate community collaboration, as described in Section 3.2.2, to optimize research impact. Applications must include a detailed Regulatory Strategy plan that outlines the approach for obtaining regulatory approvals, if required, specifically for the funded portion of the study. In addition, applications must provide a separate Transition Plan that describes how the outcomes of the study will be advanced to the next phase of development, beyond the scope of the funded work.

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