Opportunity Information: Apply for HT942526ALSRPPCTA
The FY26 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) is a Department of the Army (USAMRAA) grant opportunity designed to push ALS research quickly into the clinical testing stage. The purpose is very targeted: fund the rapid start and execution of a clinical trial that could meaningfully affect how ALS is treated or managed. The program is aimed at early clinical development, supporting trials that range from Phase 1 through small Phase 2 studies, with an emphasis on getting an intervention or care approach tested in people rather than supporting purely preclinical or observational work.
Applicants must anchor their proposal in one of two required focus areas. The first is Biomarker-Driven Interventions, which centers on disease-modifying approaches that are tied to clear, mechanism-specific biomarkers. In this track, biomarkers are not optional extras; they are expected to help identify which participants are most likely to respond, show that the therapy is engaging its intended target, and demonstrate effects on the biological pathway the intervention is meant to influence. The second focus area is Clinical Care, which supports trials intended to improve the day-to-day clinical management of ALS, including symptom management and other practical aspects of care that can improve outcomes or quality of life.
Several features of this award are meant to enforce speed, readiness, and real-world impact. Award funds must be used to support a genuine clinical trial, and the trial is expected to begin quickly after funding: no later than 12 months from the award date for most studies, or up to 18 months if the study is regulated by the U.S. Food and Drug Administration (FDA). For proposals that test a therapeutic intervention, including drugs, biologics, or devices, the program requires that biomarkers specific to that intervention be integrated into the trial design. This reflects a strong preference for trials that can produce interpretable results about mechanism and response, not just clinical outcomes alone.
The opportunity also requires intentional community collaboration as part of both pre-applications and full applications. In practical terms, this means applicants must show how they will work with the ALS community (for example, people living with ALS, caregivers, advocates, or community organizations) in ways that improve relevance, feasibility, recruitment, retention, and the usefulness of study outcomes. Alongside that, applicants must provide two planning documents that show the project is execution-ready and not a dead-end pilot. One is a detailed Regulatory Strategy plan describing how regulatory approvals will be obtained when required, specifically covering the parts of the study supported by this award. The second is a separate Transition Plan that explains what happens after the funded work ends, describing how results will be advanced into the next phase of clinical development or implementation beyond the scope of the grant.
Administratively, this is a discretionary grant opportunity (Funding Opportunity Number HT942526ALSRPPCTA) listed under CFDA 12.420. Eligibility is listed as unrestricted, meaning the program is broadly open to applicants rather than limited to a narrow set of institution types. The sponsoring agency is the Department of the Army, with administration through USAMRAA. The posted original closing date is September 30, 2026, and the program anticipates making about two awards. The award ceiling is not specified in the provided notice, so applicants would need to confirm budget limits and any cost rules in the full announcement materials.Apply for HT942526ALSRPPCTA
- The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on 2026-05-04.
- Applicants must submit their applications by 2026-09-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Unrestricted.
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FAQs: FY26 ALSRP Pilot Clinical Trial Award (PCTA)
What is the FY26 ALSRP Pilot Clinical Trial Award (PCTA)?
The FY26 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) is a discretionary grant opportunity administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of the Department of the Army. It is designed to move ALS research rapidly into clinical testing by funding the quick start and execution of a clinical trial.
What is the main purpose of this award?
The purpose is tightly focused: to fund a clinical trial that can start quickly and has the potential to meaningfully affect how ALS is treated or managed. The emphasis is on real-world clinical testing in people rather than earlier-stage or purely exploratory research.
What kinds of studies are a fit for this opportunity?
This opportunity supports early clinical development studies, including trials ranging from Phase 1 through small Phase 2. The funded work must be a genuine clinical trial intended to test an intervention or a clinical care approach in people.
Are preclinical studies or observational studies supported?
Based on the description provided, the program emphasizes clinical testing and is not aimed at supporting purely preclinical work or purely observational studies. Proposals should be framed as clinical trials with direct testing in participants.
What are the required focus areas for proposals?
Applicants must anchor their proposal in one of two required focus areas:
- Biomarker-Driven Interventions
- Clinical Care
What does "Biomarker-Driven Interventions" mean in this program?
This focus area targets disease-modifying approaches tied to clear, mechanism-specific biomarkers. Biomarkers are expected to be central to the trial, helping to identify likely responders, demonstrate target engagement, and show effects on the intended biological pathway.
Are biomarkers optional if applying under Biomarker-Driven Interventions?
No. In this track, biomarkers are described as a core expectation rather than an optional add-on. The program expects biomarkers to support participant selection/stratification, target engagement, and pathway effects.
What does the "Clinical Care" focus area support?
The Clinical Care focus area supports trials aimed at improving day-to-day clinical management of ALS, including symptom management and other practical aspects of care that could improve outcomes or quality of life.
Does the award require the funded project to be a clinical trial?
Yes. Award funds must be used to support a genuine clinical trial, and the opportunity is explicitly designed to push ALS work into the clinical testing stage.
How quickly must the clinical trial begin after award?
The trial is expected to begin no later than 12 months from the award date for most studies. For studies regulated by the U.S. Food and Drug Administration (FDA), the program allows up to 18 months from the award date to begin.
What does the program mean by "speed" and "readiness"?
The program builds in requirements that encourage rapid execution and practical impact, including a short expected timeline to trial start and the requirement for planning documents (Regulatory Strategy and Transition Plan) intended to show the project is execution-ready and positioned to advance beyond the pilot stage.
If a proposal tests a therapeutic (drug, biologic, or device), are biomarkers required?
Yes. For proposals testing a therapeutic intervention (including drugs, biologics, or devices), the program requires that biomarkers specific to that intervention be integrated into the trial design.
Why does the program emphasize intervention-specific biomarkers?
The stated intent is to support trials that produce interpretable results about mechanism and response, not only clinical outcomes. Biomarkers are expected to help show whether the intervention is engaging its target and affecting the intended biological pathway.
What is meant by "intentional community collaboration"?
Applicants must show how they will work with the ALS community (such as people living with ALS, caregivers, advocates, or community organizations) in ways that improve relevance, feasibility, recruitment, retention, and the usefulness of study outcomes.
Is community collaboration required at both the pre-application and full application stages?
Yes. The opportunity states that intentional community collaboration is required as part of both pre-applications and full applications.
What planning documents are required?
Two planning documents are required:
- Regulatory Strategy plan describing how regulatory approvals will be obtained when required, specifically covering the parts of the study supported by this award.
- Transition Plan describing what happens after the funded work ends, including how results will be advanced to the next phase of clinical development or implementation beyond the scope of the grant.
What should be included in the Regulatory Strategy plan?
The description provided indicates the Regulatory Strategy plan should explain how required regulatory approvals will be obtained and should specifically address the portions of the study supported by this award.
What is the purpose of the Transition Plan?
The Transition Plan is intended to demonstrate that the project is not a dead-end pilot. It should explain how results will be advanced into the next phase of clinical development or moved toward implementation after the funded period ends.
Who is eligible to apply?
Eligibility is listed as unrestricted, meaning the program is broadly open to applicants rather than limited to a narrow set of institution types.
Which agency sponsors and administers the award?
The sponsoring agency is the Department of the Army, and the opportunity is administered through USAMRAA.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is HT942526ALSRPPCTA.
What CFDA number is associated with this opportunity?
The opportunity is listed under CFDA 12.420.
What is the application deadline?
The posted original closing date is September 30, 2026.
How many awards does the program expect to make?
The program anticipates making about two awards.
What is the maximum award amount (ceiling)?
The award ceiling is not specified in the information provided. Applicants would need to confirm budget limits and any cost rules in the full announcement materials.
Is this a discretionary grant?
Yes. The opportunity is described as a discretionary grant opportunity.
What is the overall theme of what this program is trying to fund?
Trials that can start quickly, are designed for interpretable clinical and mechanistic learning (particularly through biomarker integration for therapeutics), incorporate meaningful collaboration with the ALS community, and include a clear plan for regulatory readiness and post-award advancement.
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Applicants also applied for:
Applicants who have applied for this opportunity (HT942526ALSRPPCTA) also looked into and applied for these:
| Funding Opportunity |
|---|
| DoW Amyotrophic Lateral Sclerosis Research Program, Clinical Outcomes and Biomarkers Award Apply for HT942526ALSRPCOBA Funding Number: HT942526ALSRPCOBA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Breast Cancer, Breakthrough Award Level 4 Apply for HT942526BCRPBTA4 Funding Number: HT942526BCRPBTA4 Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW, Ovarian Cancer, Ovarian Cancer Academy – Early-Career Investigator Award Apply for HT942526OCRPOCAECI Funding Number: HT942526OCRPOCAECI Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW, Ovarian Cancer, Ovarian Cancer Clinical Trial Academy – Early-Career Investigator Award Apply for HT942526OCRPOCCTAECI Funding Number: HT942526OCRPOCCTAECI Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Breast Cancer, Clinical Research Extension Award Apply for HT942526BCRPCREA Funding Number: HT942526BCRPCREA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Breast Cancer, Breakthrough Award Levels 1 and 2 Apply for HT942526BCRPBTA12 Funding Number: HT942526BCRPBTA12 Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Ovarian Cancer, Clinical Trial Award Apply for HT942526OCRPCTA Funding Number: HT942526OCRPCTA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Breast Cancer, Breakthrough Award Level 3 Apply for HT942526BCRPBTA3 Funding Number: HT942526BCRPBTA3 Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW, Ovarian Cancer, Investigator-Initiated Research Award Apply for HT942526OCRPIIRA Funding Number: HT942526OCRPIIRA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| NIJ FY25 Research and Evaluation on Drugs and Crime: Nexus with Firearms and Violence Apply for O NIJ 2025 172605 Funding Number: O NIJ 2025 172605 Agency: National Institute of Justice Category: Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| DoW, Ovarian Cancer, Pilot Award Apply for HT942526OCRPPA Funding Number: HT942526OCRPPA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Breast Cancer, Era of Hope Scholar Award Apply for HT942526BCRPEOHS Funding Number: HT942526BCRPEOHS Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Breast Cancer, Transformative Breast Cancer Consortium Development Award Apply for HT942526BCRPTBCCDA Funding Number: HT942526BCRPTBCCDA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Breast Cancer, Transformative Breast Cancer Consortium Award Apply for HT942526BCRPTBCCA Funding Number: HT942526BCRPTBCCA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Spinal Cord Injury, Translational Research Award Apply for HT942526SCIRPTRA Funding Number: HT942526SCIRPTRA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Hearing Restoration Focused Research Award Apply for HT942526HRRPFRA Funding Number: HT942526HRRPFRA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Multiple Sclerosis Exploration-Hypothesis Development Award Apply for HT942526MSRPEHDA Funding Number: HT942526MSRPEHDA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Multiple Sclerosis Investigator-Initiated Research Award Apply for HT942526MSRPIIRA Funding Number: HT942526MSRPIIRA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Multiple Sclerosis Early Investigator Research Award Apply for HT942526MSRPEIRA Funding Number: HT942526MSRPEIRA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoW Spinal Cord Injury, Clinical Translation Research Award Apply for HT942526SCIRPCTRA Funding Number: HT942526SCIRPCTRA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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