Safety and short-term outcomes of lecanemab for Alzheimer's disease in China: a multicentre study

Abstract Lecanemab is a newly approved monoclonal antibody targeting amyloid plaques for the treatment of early Alzheimer’s disease. This study aimed to evaluate the safety and short-term biomarkers and cognition changes of lecanemab in Chinese clinical practice. This multicenter real-world study involved patients receiving lecanemab treatment across seven hospitals in China. Patients underwent comprehensive assessments before treatment. Lecanemab was administered via intravenous infusion every 2 weeks. Treatment-related symptoms were monitored through self-report, and amyloid-related imaging abnormalities were assessed via magnetic resonance imaging. Amyloid and tau biomarker changes were measured using positron emission tomography imaging or plasma testing. Follow-up cognitive assessments were evaluated after 6 months of treatment. Short-term outcomes were analyzed using linear mixed-effect models, without an untreated control group. A total of 407 patients who received at least one lecanemab infusion were involved in this study, with a mean follow-up time of 5.6±3.39 months. The mean age was 68.08 years, with 67.57% of patients being female. Of the participants, 56.51% were APOE ε4 carriers, and 83.19% were at biological stage C. During the study period, 22.22% of the patients experienced treatment-related symptoms, and 12.15% developed at least one amyloid-related imaging abnormality. Only four symptomatic and seven severe amyloid-related imaging abnormality cases were reported. APOE ε4 status was not related to adverse events in the Chinese population. Patients with a higher number of microhemorrhages at baseline were more likely to develop adverse events. No significant differences in adverse events were observed between the moderate Alzheimer’s disease dementia group and the mild cognitive impairment group. By the end of the research period, 9.38% of the patients withdrew from lecanemab. After 6 months of treatment, favourable short-term outcomes in biomarkers and stable cognitive function were observed. This study demonstrates that lecanemab treatment is feasible and well-tolerated among the Chinese population, with lower rates of adverse events and favourable short-term outcomes observed. Administration of lecanemab in moderate AD dementia population was relatively safe and further studies are warranted.