Simpler Grants.gov #HT942526ALSRPPCTA

DoD ALS Research Program: Pilot Clinical Trial Grant Opportunity for Biomarker-Driven ALS Interventions

The Department of Defense, through the Defense Health Agency's Congressionally Directed Medical Research Programs (CDMRP) and the US Army Medical Research Acquisition Activity (USAMRAA), is soliciting grant applications for the FY26 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award. - Funding supports phase 1 to small-scale phase 2 clinical trials focused on ALS (Amyotrophic Lateral Sclerosis) - Emphasis on biomarker-driven, disease-modifying interventions with mechanism-specific biomarkers - Also supports clinical care and symptom management improvements for ALS - Projects proposing therapeutic interventions (drugs, biologics, or devices) must incorporate relevant biomarkers into the trial design - All applications must include: - Community collaboration - A detailed regulatory strategy for obtaining necessary approvals - A transition plan for advancing study outcomes beyond the funded work - Approximately $5.6 million in total funding is available, with up to two awards of $2.8 million each - Maximum period of performance is three years - No cost sharing or matching required; open to all eligible applicants - No specific OEMs, vendors, or commercial products are named, as this is a research grant opportunity - Place of performance and contracting managed by federal medical research offices (USAMRAA and DHA R&D)

Description

The fiscal year 2026 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award supports the rapid implementation of clinical trials with potential significant impact on the treatment or management of ALS. Projects may range from phase 1 to small-scale phase 2 trials. Focus areas include biomarker-driven interventions and clinical care improvements. Funding requires clinical trials to begin within 12 months or 18 months for FDA-regulated studies, with required community collaboration and regulatory strategy plans.

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