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Pharmacological treatment trials of agitation in Alzheimer's disease: A systematic review of ClinicalTrials.gov registered trials

Liu, KY; Borissova, A; Mahmood, J; Elliott, T; Knowles, M; Bentham, P; Reeves, S; (2021) Pharmacological treatment trials of agitation in Alzheimer's disease: A systematic review of ClinicalTrials.gov registered trials. Alzheimer's & Dementia: Translational Research & Clinical Interventions , 7 (1) , Article e12157. 10.1002/trc2.12157. Green open access

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Abstract

INTRODUCTION: There is increasing emphasis on the importance of optimizing and standardizing clinical trials of agitation in Alzheimer's disease (AD), but the risks of bias arising from published trials and the number and design of unpublished studies are poorly understood. METHODS: Using the ClinicalTrials.gov database, we systematically reviewed all registered investigational clinical trials for agitation in AD to describe the landscape of agitation drug treatment trials and to assess their quality and generalizability. RESULTS: We included 52 clinical studies registered over the past 25 years. Within published randomized controlled trials (RCTs), there was a high rate of participant dropout, poor reporting of randomization procedures, and inconsistent definitions of the sample included for analysis. There was also evidence of publication and funder bias. DISCUSSION: We discuss factors that limit the internal and external validity of published RCTs and make additional recommendations for the conduct and reporting of future clinical trials of agitation in AD.

Type: Article
Title: Pharmacological treatment trials of agitation in Alzheimer's disease: A systematic review of ClinicalTrials.gov registered trials
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/trc2.12157
Publisher version: https://doi.org/10.1002/trc2.12157
Language: English
Additional information: © 2021 The Authors. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
Keywords: Agitation, Alzheimer's disease, clinical trials, dementia, systematic review
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
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 > Division of Psychiatry
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry > Mental Health of Older People
URI: https://discovery.ucl.ac.uk/id/eprint/10125473
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