DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

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.

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

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

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