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Amyotrophic Lateral Sclerosis

NEWS RELEASE

Released: January 03, 2024

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Amyotrophic Lateral Sclerosis Research Program
Anticipated Funding Opportunities for Fiscal Year 2024 (FY24)

The FY24 Defense Appropriations Bill has not been signed into law. Although FY24 funds have not been appropriated for the Amyotrophic Lateral Sclerosis Research Program (ALSRP), the ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY24 funding opportunities. This pre-announcement should not be construed as an obligation by the Government.

The FY24 Defense Appropriations Act is anticipated to provide funding for the ALSRP to support development of effective treatments for ALS. The managing agent for the anticipated funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

The ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY24 funding opportunities. The FY24 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.

New for FY24! Applications submitted to the FY24 ALSRP Pilot Clinical Trial Award must address one Focus Area when submitting their application, as outlined below:

  • Interventions:   Biomarker-driven, disease-modifying interventions for ALS
  • Clinical Care:   Improving aspects of clinical care and symptom management for ALS

New for FY24! Applications submitted to the FY24 ALSRP Clinical Outcomes and Biomarkers Award must address one or both Focus Areas when submitting their application, as outlined below:

  • Clinical Biomarkers:   Identification, development, and/or validation of promising biomarkers for ALS
  • Clinical Outcomes:   Identification, development, and/or validation of clinician-, observer-, or patient-reported, and/or performance outcome measures for ALS


Award Mechanism Eligibility Key Mechanism Elements Funding
Pilot Clinical Trial Award Independent investigators at any career level
  • Supports exploratory clinical trials of novel therapeutics or devices to demonstrate feasibility and inform the design of more advanced trials in ALS.
  • Supports clinical trials that may optimize aspects of multi-disciplinary ALS care or therapies for symptom management.
  • Must support a clinical trial and may not be used for preclinical research studies.

New for FY24! Applications must address one Focus Area:
  • Interventions: Biomarker-driven, disease-modifying interventions for ALS
    • OR
  • Clinical Care: Improving aspects of clinical care and symptom management for ALS
    • Examples of efforts that will be supported under the Clinical Care Focus Area include, but are not limited to:
      • Optimization of respiratory care strategies
      • Improvements to approved devices and assistive technologies
      • Specific symptom management strategies
      • Telemedicine strategies
  • Submission of a pre-application is required; full application submission is by invitation only.
    • Maximum funding of $2,000,000 for direct costs (plus indirect costs)

    • Maximum period of performance is 4 years
    Clinical Outcomes and Biomarkers Award Independent investigators at any career level
    • Supports development, improvement, and validation of clinical outcomes and/or biomarkers to enrich clinical trials in ALS.
    • Biomarker analysis can be relevant to a specific therapeutic or a specific ALS subtype and does not have to broadly apply to all patients.
    • A description of the biomarker category and intended context of is an important component.
    • Examples of efforts that will be supported include, but are not limited to:
      • Using patient-based resources to link biosamples to rigorous molecular data.
      • Collecting and analyzing biospecimens and/or outcomes to augment an anticipated/ongoing clinical trial.
      • Correlation of clinical trial-related data with clinical outcomes/responses to therapies.
      • Strategies to better measure disease progression, including development and/or use of digital biomarkers.
    New for FY24!  Applications must address one or both Focus Areas:
    • Clinical Biomarkers:  Identification, development, and/or validation of promising biomarkers for ALS
    • Clinical Outcomes:  Identification, development, and/or validation of clinician-, observer-, or patient-reported, and/or performance outcome measures for ALS
    • Submission of a pre-application is required; full 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 (IND)-enabling studies of therapeutics for ALS.
    • Preliminary data are required including therapeutic efficacy in at least one 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 pre-application is required; full 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 highly innovative, hypothesis-driven preclinical therapeutic development in ALS.
    • Projects focusing primarily on ALS pathophysiology, without consideration of therapeutic development, are outside the scope of this award mechanism.
    • New for FY24!   All applications must include the development of biomarkers in parallel to the main therapeutic effort to qualify for funding.
    • Preliminary data is not required.
    • The strength of the application should rely on the innovative approach.
    • Submission of a pre-application is required; full 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 announcement 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
    usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@health.mil


    Last updated Thursday, February 8, 2024