Rodriguez-Porcel, Federico;
Wyman-Chick, Kathryn A;
Abdelnour Ruiz, Carla;
Toledo, Jon B;
Ferreira, Daniel;
Urwyler, Prabitha;
Weil, Rimona S;
... Lewis, Simon JG; + view all
(2022)
Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations.
Translational Neurodegeneration
, 11
(1)
, Article 24. 10.1186/s40035-022-00299-w.
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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.
| Type: | Article |
|---|---|
| Title: | Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s40035-022-00299-w |
| Publisher version: | https://doi.org/10.1186/s40035-022-00299-w |
| Language: | English |
| Additional information: | Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| Keywords: | Dementia with Lewy bodies, Clinical trials, Outcomes, Measurement properties, SLEEP BEHAVIOR DISORDER, PARKINSONS-DISEASE DEMENTIA, MINI-MENTAL-STATE, MONTREAL COGNITIVE ASSESSMENT, RATING-SCALE SUM, OPEN-LABEL TRIAL, ALZHEIMERS-DISEASE, NEUROPSYCHIATRIC INVENTORY, VISUAL HALLUCINATIONS, DOUBLE-BLIND |
| UCL classification: | UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Neurodegenerative Diseases UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10148849 |
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