Safety of lecanemab in real-world patients with Alzheimer's disease: a prospective, observational case series supported by FAERS signal analysis

Objective

Lecanemab, a humanized immunoglobulin monoclonal antibody, has been approved for the treatment of Alzheimer's disease (AD). Although clinical trials have demonstrated its favorable safety profile, real-world studies are crucial for identifying rare adverse events (AEs) and evaluating post-marketing safety. This study aimed to evaluate the safety of lecanemab by combining a clinical prospective, observational case cohort with data from the FAERS database, thereby providing a robust basis for the identification of potential safety signals.