Dementia with Lewy bodies Drug Therapies in Clinical Trials: 2022

Abstract

AbstractBackgroundReviews of randomized clinical trials (RCTs) in Dementia with Lewy bodies (DLB) are essential for informing ongoing research efforts of symptomatic therapies and potentially disease‐modifying therapies (DMTs).MethodsWe performed a Systematic Review of DLB drug development by examining 3 international registries: ClinicalTrials.gov, the European Union Drug Regulating Authorities Clinical Trials Database, and the International Clinical Trials Registry Platform, to identify drugs in trials in DLB. We analyzed recruitment status, the disease stage and diagnostic groups included in clinical trials, number of trials participants and treatment exposure, use of repurposed agents per clinical trial phase, description of outcome measures for primary endpoints, use of biomarkers for inclusion and/or outcome measures, sponsorship, and global distribution.ResultsWe found 25 agents in 40 trials assessing symptomatic treatments and disease modifying therapies for DLB: 7 Phase 3, 31 Phase 2, and 2 Phase 1 trials. We found an active pipeline for drug development in DLB, with most ongoing clinical trials in phase 2. We identified a recent trend towards including participants at the prodromal stages, although more than half of active clinical trials will enroll mild to moderate dementia patients. Additionally, repurposed agents are frequently tested representing 65% of clinical trials.ConclusionTo accelerate DLB drug development there is a need for more clinical trials, increased diagnosis at earlier stages of the disease, disease‐specific outcome measures and biomarkers, as well as augmenting global representation and including more diverse populations.