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Drug Development.

Joe Pm Kane1, Brad F Boeve2, Elie Matar3

  • 1Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
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Summary
This summary is machine-generated.

A new Lewy Body Dementia-Domain Rating Scale (LBD-DRS) is being developed to address the critical need for LBD-specific outcome measures in clinical trials. This scale aims to improve drug development and data harmonization for Lewy Body Dementia research.

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Area of Science:

  • Neurology
  • Clinical Trials
  • Dementia Research

Background:

  • Current Lewy Body Dementia (LBD) trials utilize scales designed for Alzheimer's and Parkinson's diseases, representing a critical unmet need.
  • Heterogeneity in trial design and outcome measures hinders evidence synthesis and data harmonization in LBD research.
  • The development of an LBD-specific scale is crucial for advancing drug development pipelines.

Purpose of the Study:

  • To describe the development of the Lewy Body Dementia-Domain Rating Scale (LBD-DRS).
  • To propose a roadmap for the adoption and validation of the LBD-DRS.
  • To address the critical unmet need for LBD-specific outcome measures in clinical trials.

Main Methods:

  • A three-round Delphi survey process was employed, involving LBD researchers and clinicians.
  • Consensus was defined as agreement among ≥75% of respondents on survey statements.
  • The process focused on establishing consensus around the conceptual framework and preliminary content of the LBD-DRS.

Main Results:

  • Consensus was achieved regarding the necessity of an LBD-specific scale, particularly for early-stage LBD.
  • A third version of the LBD-DRS has been developed based on feedback from two earlier versions.
  • An inclusive scoring approach for symptoms has been adopted, acknowledging the need for future iterations with field data.

Conclusions:

  • Further development of the LBD-DRS will involve consultation with diverse stakeholders, including individuals with LBD and their care partners.
  • Engagement with regulatory bodies and the pharmaceutical industry will inform subsequent development phases.
  • Validation studies will be pursued after comprehensive stakeholder consultation and regulatory engagement.