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

Federico Rodriguez-Porcel*, Kathryn Wyman-Chick, Carla Abdelnour-Ruiz, Jon Toledo, Daniel Ferreira, Prabitha Urwyler, Rimona Weil, Joseph Kane, Andrea Pilotto, Arvid Rongve, Bradley F. Boeve, John-Paul Taylor, Ian McKeith, Dag Aarsland, Simon J G Lewis

*Corresponding author for this work

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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
JournalTranslational Neurodegeneration
Volume11
DOIs
Publication statusPublished - 02 May 2022

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