Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations

Federico Rodriguez-Porcel*, Kathryn A. Wyman-Chick, Carla Abdelnour Ruiz, Jon B. Toledo, Daniel Ferreira, Prabitha Urwyler, Rimona S. Weil, Joseph Kane, Andrea Pilotto, Arvid Rongve, Bradley Boeve, John-Paul Taylor, Ian McKeith, Dag Aarsland, Simon J. G. Lewis, the Lewy Body Dementias Clinical Trials Workgroup from the Lewy Body Dementias Professional Interest Area - Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART)+

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

6 Citations (Scopus)

Abstract

The selection of appropriate outcome measures is fundamental to the design of any successful clinical trial. Although dementia with Lewy bodies (DLB) is one of the most common neurodegenerative conditions, assessment of therapeutic benefit in clinical trials often relies on tools developed for other conditions, such as Alzheimer’s or Parkinson’s disease. These may not be sufficiently valid or sensitive to treatment changes in DLB, decreasing their utility. In this review, we discuss the limitations and strengths of selected available tools used to measure DLB-associated outcomes in clinical trials and highlight the potential roles for more specific objective measures. We emphasize that the existing outcome measures require validation in the DLB population and that DLB-specific outcomes need to be developed. Finally, we highlight how the selection of outcome measures may vary between symptomatic and disease-modifying therapy trials.

Original languageEnglish
Article number24
Pages (from-to)1-18
Number of pages18
JournalTranslational Neurodegeneration
Volume11
Issue number1
DOIs
Publication statusPublished - 2 May 2022
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Clinical trials
  • Dementia with Lewy bodies
  • Measurement properties
  • Outcomes

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