Abstract：
UNASSIGNED: In July 2023, the U.S. Food and Drug Administration (FDA) granted full approval to lecanemab for the treatment of mild cognitive impairment (MCI) due to Alzheimer\'s disease (AD) and mild AD dementia. Considering the limited treatment options for AD, the approval of lecanemab offers hope and opens the door for other disease-modifying therapies in the pipeline.
UNASSIGNED: In this review, the authors summarize the FDA treatment guidelines, other anti-amyloid agents, and drug information relevant to prescribers, such as pharmacology and pharmacokinetics. Relevant clinical trial outcomes are discussed along with their significance and controversies.
UNASSIGNED: While questions remain about the magnitude of lecanemab\'s clinical impact, its approval signifies major progress in addressing the underlying pathology of AD. The authors have confidence in lecanemab as a promising treatment option and foresee exciting advancements on the 5-year horizon. Yet, further research is needed regarding trials beyond 18 months, post-marketing surveillance, and lecanameb in combination with existing treatments and lifestyle interventions.
UNASSIGNED: In this review, the authors summarize the FDA treatment guidelines, other anti-amyloid agents, and drug information relevant to prescribers, such as pharmacology and pharmacokinetics. Relevant clinical trial outcomes are discussed along with their significance and controversies.
UNASSIGNED: While questions remain about the magnitude of lecanemab\'s clinical impact, its approval signifies major progress in addressing the underlying pathology of AD. The authors have confidence in lecanemab as a promising treatment option and foresee exciting advancements on the 5-year horizon. Yet, further research is needed regarding trials beyond 18 months, post-marketing surveillance, and lecanameb in combination with existing treatments and lifestyle interventions.
摘要：
2023年7月，美国食品和药物管理局（FDA）批准leanemab用于治疗阿尔茨海默病（AD）和轻度AD痴呆引起的轻度认知障碍（MCI）。考虑到AD的治疗选择有限，lecanemab的批准提供了希望，并为正在进行的其他疾病改善疗法打开了大门。
■在这篇评论中，作者总结了FDA的治疗指南，其他抗淀粉样蛋白药物，以及与处方者有关的药物信息，如药理学和药代动力学。讨论了相关的临床试验结果及其意义和争议。
■虽然关于lecanemab的临床影响的程度仍然存在疑问，它的批准标志着在解决AD的潜在病理方面取得了重大进展。作者对lecanemab作为一种有前途的治疗选择充满信心，并预见了5年的令人兴奋的进步。然而，需要进一步研究超过18个月的试验，上市后监督,与现有治疗和生活方式干预相结合。
■在这篇评论中，作者总结了FDA的治疗指南，其他抗淀粉样蛋白药物，以及与处方者有关的药物信息，如药理学和药代动力学。讨论了相关的临床试验结果及其意义和争议。
■虽然关于lecanemab的临床影响的程度仍然存在疑问，它的批准标志着在解决AD的潜在病理方面取得了重大进展。作者对lecanemab作为一种有前途的治疗选择充满信心，并预见了5年的令人兴奋的进步。然而，需要进一步研究超过18个月的试验，上市后监督,与现有治疗和生活方式干预相结合。
