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DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

Dept. of Defense — CDMRP · Other Federal · HT942526ALSRPPCTA

Source: Grants.gov · View original posting ↗

Award
$5.6M total
Deadline
Sep 30, 2026
Letter of intent
Mechanism
Duration
Expected awards
2
Funding cycle
Unknown
Open date
May 4, 2026
Total funding
$5.6M total
Clinical trial
Unspecified
Higher educationNonprofitSmall businessGovernment

Research areas

Basic mechanisms & biologyBiomarkers & diagnosticsTherapeutics & drug discoveryClinical trials

Auto-classified from the title and description (keyword-based) — may be imperfect.

Description

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.