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DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

ID: HT942526ALSRPPCTA • Type: Posted
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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.

Background
The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) is administered by the Defense Health Agency (DHA). It aims to support the rapid implementation of clinical trials that could significantly impact the treatment or management of amyotrophic lateral sclerosis (ALS). The ALSRP was initiated by Congress in 2007 to fund research with high potential impact and exceptional scientific merit, with a total appropriation of $40 million for FY26.

Grant Details
The PCTA supports clinical trials ranging from phase 1 to small-scale phase 2 trials. Applications must focus on either:
1) Biomarker-Driven Interventions, which involve disease-modifying interventions with mechanism-specific biomarkers; or
2) Clinical Care, aimed at improving clinical care and symptom management for ALS. Funding must support a clinical trial that begins no later than 12 months after the award date (or 18 months for FDA-regulated studies). Projects proposing therapeutic interventions must incorporate relevant biomarkers into the trial design. All applications are required to include community collaboration and a detailed Regulatory Strategy plan outlining how regulatory approvals will be obtained. Additionally, a Transition Plan must describe how study outcomes will advance to subsequent development phases beyond the funded work.

Eligibility Requirements
Eligible applicants include extramural and intramural U.S. Department of War organizations, foreign and domestic organizations, for-profit and nonprofit entities, and public or private organizations. Independent investigators affiliated with eligible organizations can serve as Principal Investigators regardless of ethnicity, nationality, or citizenship status. An investigator may be named as PI on no more than three FY26 ALSRP applications across all award mechanisms.

Period of Performance
The maximum period of performance for this grant is three years.

Grant Value
The total funding available is approximately $5.6 million, with individual awards capped at $2.8 million each.

Place of Performance
The grant will be performed in locations determined by the applicant organization.
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Overview

Agency
U.S. Army Medical Research Acquisition Activity (USAMRAA) [DoD - USA - MEDCOM - MRDC]
Category of Funding
Science and Technology and other Research and Development
Funding Instruments
Grant
Grant Program (CFDA)
12.420 - Military Medical Research and Development
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 5/4/26 U.S. Army Medical Research Acquisition Activity posted grant opportunity HT942526ALSRPPCTA for DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award with funding of $5.6 million. The grant will be issued under grant program 12.420 Military Medical Research and Development. It is expected that 2 total grants will be made.

Timing

Posted Date
May 4, 2026, 12:00 a.m. EDT
Closing Date
Sept. 30, 2026, 12:00 a.m. EDT Due in 122 Days
Last Updated
May 4, 2026, 9:42 a.m. EDT
Version
1
Archive Date
Oct. 30, 2026

Eligibility

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

Award Sizing

Ceiling
Not Listed
Floor
Not Listed
Estimated Program Funding
$5,600,000
Estimated Number of Grants
2

Contacts

Contact
Jamie Shortall Grant Officer
Contact Email
help@ebrap.org   Profile
Email Description
eBRAP Help Desk
Contact Phone
(301) 619-2393

Documents

Posted documents for HT942526ALSRPPCTA

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