Exploring the efficacy and safety of lecanemab in the management of early Alzheimer's disease: A systematic review of clinical evidence

Abstract

BackgroundAlzheimer's disease (AD) is a growing neurodegenerative disorder causing cognitive decline, memory loss, and functional impairment. Lecanemab has shown safety and efficacy in clinical trials.ObjectiveThis review aims to understand the clinical evidence of lecanemab's effectiveness and safety in managing early AD.MethodsA systematic search was conducted using the Scopus database and ClinicalTrials.gov. Studies from 2014 to 2024 on lecanemab's safety, efficacy, and clinical outcomes for AD were included. Data extraction involved two independent reviewers, with synthesis using qualitative methodology.ResultsFindings from 13 studies and 13 ongoing clinical trials were reported, showing that lecanemab substantially reduces amyloid plaque load in the brains of AD patients. The therapeutic regimens vary across reported studies and trials, ranging from 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly, and 10 mg/kg intravenously biweekly. The Clarity AD phase 3 trial, the AHEAD study, and the DIAN-TU-001 trials have reported positive study outcomes with robust efficacy and safety outcomes with minimal side effects. Completed and ongoing trials report on the onset of amyloid-related imaging abnormalities (ARIA) and the continuation of care status following the onset of ARIA in these patients. The common infusion-related reactions were observed in 26.4% of the lecanemab group compared to 7% in the placebo group.ConclusionsThe management of AD has evolved over the years with the introduction of novel therapeutic agents like lecanemab. While its safety profile is generally favorable, careful monitoring is essential.

Keywords: Alzheimer's disease; BAN2401; amyloid-beta; lecanemab.