Abstract: Alzheimer’s disease (AD) is a major neurodegenerative disorder characterized by progressive cognitive decline and functional impairment. Its prolonged and insidious progression highlights the urgent need for effective disease-modifying therapies (DMTs). Lecanemab, a humanized monoclonal antibody that selectively targets soluble amyloid-β (Aβ) oligomers and protofibrils, is among the first DMTs approved by international regulatory agencies for the treatment of early-stage AD. In recent years, accumulating evidences from randomized clinical trials, long-term extension studies, and multiple real-world cohorts have provided a clearer understanding of its efficacy and safety. This review summarizes the pharmacological characteristics of lecanemab, key clinical findings, biomarker responses, adverse event profiles, and management strategies. Furthermore, drawing on emerging real-world data from China, we discuss its potential implications for clinical practice and explore future directions by addressing current research controversies and cutting-edge advancements to support the standardized management of cognitive impairment in older adults.

Key words: lecanemab, Alzheimer’s disease, β-amyloid, biomarker, disease-modifying therapy, real-world study