Open AccessPharmacological treatment trials of agitation in Alzheimer's disease: A systematic review of ClinicalTrials.gov registered trials
Author(s) -
Liu Kathy Y.,
Borissova Anya,
Mahmood Jansher,
Elliott Thomas,
Knowles Melanie,
Bentham Peter,
Reeves Suzanne,
Howard Robert
Publication year - 2021
Publication title -
alzheimer's and dementia: translational research and clinical interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.49
H-Index - 30
ISSN - 2352-8737
DOI - 10.1002/trc2.12157
Subject(s) - generalizability theory , clinical trial , medicine , consolidated standards of reporting trials , randomized controlled trial , randomization , internal validity , drug trial , medline , intensive care medicine , psychology , pathology , political science , law , developmental psychology
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agitation in Alzheimer's disease (AD), but the risks of bias arising from published trials and the number and design of unpublished studies are poorly understood.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.