At a glance
This program funds rapid-start pilot clinical trials for amyotrophic lateral sclerosis (ALS), including phase 1 and small-scale phase 2 studies. Applicants must be eligible U.S. Department of War organizations, including foreign and domestic, for-profit and nonprofit, and public or private entities, and awards go to organizations rather than individuals. The program expects about $5.6 million to support roughly two awards, with total costs capped at $2.8 million per award and a maximum performance period of three years. Cost sharing is not required. Applications must address either biomarker-driven interventions or clinical care, and preclinical research is not supported.
What it funds
Official description from grants.gov
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.
Who can apply
- Unrestricted