DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award
About
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 additi.
The DoW Amyotrophic Lateral Sclerosis Research Program Pilot Clinical Trial Award supports researchers and clinical teams ready to rapidly implement clinical trials that could significantly advance ALS treatment and management. This grant is designed for organizations conducting Phase 1 through small-scale Phase 2 trials focused on two key areas: biomarker-driven interventions that identify which patients will respond to specific treatments, and clinical care improvements that enhance symptom management and quality of life for ALS patients. Researchers should apply if they have a well-developed clinical trial protocol ready to launch within 12-18 months of funding. The program prioritizes projects incorporating biomarkers specific to therapeutic interventions (drugs, biologics, or devices) and requires meaningful community collaboration to maximize research impact. This award represents a critical opportunity for research teams positioned to move promising ALS treatments from concept to clinical testing, potentially accelerating breakthroughs in this devastating neurodegenerative disease. The emphasis on rapid implementation and regulatory strategy planning makes this ideal for teams with mature protocols and institutional support ready for swift execution.
Funding Facts
● Applications openDeadline
September 30, 2026
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Amount varies by cycle
Deadline
2026-09-30
Grant Type
federal
Application Cycle
Annual (FY2026 deadline: September 30, 2026)
Best For
Research institutions and clinical teams with mature ALS treatment protocols ready for rapid clinical trial implementation
Frequently Asked Questions
Who is eligible for DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award?
While specific eligibility criteria are not detailed in the available information, this award targets researchers and institutions prepared to conduct clinical trials for ALS treatments. Applicants must be able to implement a clinical trial within 12 months of award (or 18 months for FDA-regulated studies) and demonstrate capability for community collaboration. For complete eligibility requirements regarding institutional types, researcher qualifications, and funding history restrictions, visit the official Department of Defense grant website.
How much funding does DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award provide?
Specific funding amounts are not specified for this award cycle. The award amount may vary depending on project scope and phase. Applicants should review the official program announcement and contact the administering agency for current funding levels and budget limitations.
How do I apply for DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award?
Applications require submission of both pre-applications and full applications through the Department of Defense's official grants portal. All submissions must include a detailed Regulatory Strategy plan outlining your approach to obtaining necessary regulatory approvals. Community collaboration plans are mandatory. The deadline for FY2026 is September 30, 2026. Visit the official DoD ALSRP website for complete submission guidelines, required forms, and specific application procedures.
What can DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award funding be used for?
Funding must specifically support clinical trial implementation. Eligible projects include Phase 1 to small-scale Phase 2 clinical trials focused on biomarker-driven interventions with mechanism-specific biomarkers, or clinical care improvements for symptom management. Projects proposing therapeutic interventions (drugs, biologics, devices) must incorporate intervention-specific biomarkers into trial design. Funding cannot be used for non-clinical research activities. The trial must be ready to begin within 12-18 months of the award date.
Last updated: July 5, 2026