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Amyotrophic Lateral Sclerosis

NEWS RELEASE

Released: March 28, 2025

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Amyotrophic Lateral Sclerosis Research Program
Anticipated Funding Opportunities for Fiscal Year 2025 (FY25)

The Full-Year Continuing Appropriations and Extensions Act of 2025 provides $650M in funding for the CDMRP. Congress provided further guidance for CDMRP program-level funding, including funding for the Amyotrophic Lateral Sclerosis Research Program (ALSRP). The FY25 ALSRP intends to support the development of effective treatments for ALS. The CDMRP is part of the Defense Health Agency Research and Development at the U.S. Army Medical Research and Development Command (USAMRDC) and is the program office managing these anticipated FY25 funding opportunities.

The ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY25 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY25 ALSRP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.

The FY25 ALSRP funding opportunity announcements for the following award mechanisms are anticipated to be posted on the Grants.gov website.


Award Mechanism Eligibility Key Mechanism Elements Funding
Pilot Clinical Trial Award Independent investigators at any career level
  • Projects may range from phase 1 to small phase 2 trials and should aim to de-risk and inform the design of more advanced trials.
  • Must support a clinical trial and may not be used for preclinical research studies.
Applications must address one focus area:
  • Biomarker-Driven Interventions: Disease-modifying interventions of novel therapeutics or devices, incorporating mechanism-specific predictive, efficacy, and/or pharmacodynamic biomarkers.
    OR
  • Clinical Care: Improving existing clinical care and/or symptom management strategies.
  • Must include a Community Partner (e.g., patient/caregiver advisory panel) who will provide advice and consultation throughout trial planning and implementation.
Submission of a preproposal is required; application submission is by invitation only.
  • Maximum funding of $2,000,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Clinical Outcomes and Biomarkers Award Independent investigators at any career level
  • Supports the development and validation of clinical outcomes and/or biomarkers to improve clinical trials in ALS.
  • Data sharing plans are an important and scored component.
  • Interventional clinical trials are not allowed. However, non-interventional studies prospectively collecting biospecimens and/or data are permitted, including in parallel/add-on to existing trials.
  • Projects that include prospective enrollment must include a Community Partner (e.g., patient/caregiver advisory panel) who will provide advice and consultation throughout study planning and implementation.
  • Can be relevant to a specific therapeutic or a specific ALS subtype and does not have to broadly apply to all patients.
Applications can address one or both focus areas:
  • Clinical Biomarkers: Identification, development, and/or validation of promising biomarkers for ALS. Biomarkers may include, but are not limited to susceptibility/risk, diagnostic, monitoring, prognostic, predictive, response, or safety biomarkers.
  • Clinical Outcomes: Identification, development, and/or validation of clinician-, observer-, or patient-reported, and/or performance outcome measures for ALS.
Submission of a preproposal is required; application submission is by invitation only.
  • Maximum funding of $750,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Therapeutic Development Award Independent investigators at any career level
  • Supports secondary preclinical validation and/or Investigational New Drug-enabling studies of therapeutics for ALS.
  • Must begin with lead compound(s) in hand.
  • Preliminary data are required including therapeutic efficacy in at least one relevant preclinical ALS model system.
  • Mechanism-specific predictive/cohort-selective, target engagement, and pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component. If mechanism-specific biomarkers are already available or currently in development, how the existing biomarkers will improve trial design, patient selection, and efficiency or interpretation of the proposed ALS therapeutic approach must be described.
Submission of a preproposal is required; application submission is by invitation only.
  • Maximum funding of $1,500,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years
Therapeutic Idea Award Independent investigators at any career level
  • Supports new, innovative, high-risk, high-gain hypothesis-driven ideas aimed at ALS drug or therapy discovery.
  • Preliminary data are not required, though strong scientific rationale and experimental feasibility are important.
  • Projects focusing primarily on ALS pathophysiology without development of a therapy are not allowed.
  • All applications must include an aspect of mechanism-specific biomarker development in parallel to the main therapeutic effort.
  • Proposals can be for a specific ALS subtype and do not have to broadly apply to all patients.
Submission of a preproposal is required; application submission is by invitation only.
  • Maximum funding of $600,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 2 years

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final funding opportunity announcements that will be available for downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Submission deadlines are not available until the funding opportunity announcements are released. For email notification when announcements are released, subscribe to program-specific news and updates under "Email Subscriptions" on the eBRAP homepage at https://eBRAP.org. For more information about the ALSRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).

Point of Contact:
CDMRP Public Affairs
301-619-9783
dha.detrick.cdmrp.mbx.public-affairs@health.mil


Last updated Thursday, March 27, 2025


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