Jeon So Yeon, Wang Sheng-Min, Roh Hyun Woong, Kim Keun You, Chang Yoon Young, Kim Eosu, Bae Jae-Nam, Ryu Seung-Ho
Department of Psychiatry, Seoul Metropolitan Government Seoul National University (SMG-SNU) Boramae Medical Center, Seoul, Korea.
Department of Psychiatry, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
J Korean Med Sci. 2025 Jul 21;40(28):e215. doi: 10.3346/jkms.2025.40.e215.
The advent of anti-amyloid monoclonal antibody (mAb) therapies represents a paradigm shift in the treatment of Alzheimer's disease (AD), from symptomatic relief to disease modification. Lecanemab, a humanized mAb targeting soluble Aβ protofibrils and plaque, received regulatory approval in Korea in July 2024, following global randomized controlled trial data demonstrating its efficacy to reduce amyloid burden and slow cognitive decline. However, the introduction of such therapies into routine clinical realm presents several practical and systemic challenges, particularly in the context of Korea's unique healthcare infrastructure and reimbursement environment. In response, the Korean Association for Geriatric Psychiatry has developed the first comprehensive domestic guidance to facilitate the safe, evidence-based, and patient-centered use of anti-amyloid mAb therapies, first focused on lecanemab. This practical guide goes beyond simple eligibility criteria. It provides detailed recommendations on clinical and imaging-based candidate selection, amyloid-related imaging abnormalities (ARIA) risk stratification and monitoring protocols, infusion workflows, adverse event management strategies, and multidisciplinary coordination within hospital systems. It also emphasizes shared decision-making and outlines how to navigate situations where treatment is not appropriate, such as in patients with advanced dementia, high-risk magnetic resonance imaging findings, or poor treatment adherence, reinforcing that non-treatment can also represent a legitimate, evidence-based clinical decision. The guidance further highlights the urgent need to generate real-world data that reflect the treatment experiences of Korean patients. Multicenter collaboration will be essential for collecting data on adherence rates, ARIA incidence, cognitive outcomes, and functional trajectories, which in turn can inform policy decisions, insurance reimbursement models, and future updates to clinical guidelines. This publication represents the first nationwide roadmap in Korea to support clinicians in the appropriate integration of monoclonal antibody therapies for AD. By combining scientific rigor, operational feasibility, and ethical sensitivity, it aims to promote safe and responsible adoption of disease-modifying treatment across various clinical settings.
抗淀粉样蛋白单克隆抗体（mAb）疗法的出现代表了阿尔茨海默病（AD）治疗的范式转变，从缓解症状转向疾病修饰。lecanemab是一种靶向可溶性Aβ原纤维和斑块的人源化单克隆抗体，在全球随机对照试验数据证明其降低淀粉样蛋白负荷和减缓认知衰退的疗效后，于2024年7月在韩国获得监管批准。然而，将此类疗法引入常规临床领域面临一些实际和系统性挑战，特别是在韩国独特的医疗保健基础设施和报销环境背景下。对此，韩国老年精神病学协会制定了首个全面的国内指南，以促进抗淀粉样蛋白单克隆抗体疗法的安全、循证和以患者为中心的使用，首先聚焦于lecanemab。这份实用指南超越了简单的资格标准。它提供了关于基于临床和影像学的候选者选择、淀粉样蛋白相关影像学异常（ARIA）风险分层和监测方案、输注流程、不良事件管理策略以及医院系统内多学科协调的详细建议。它还强调了共同决策，并概述了如何应对治疗不适用的情况，例如晚期痴呆患者、高风险磁共振成像结果患者或治疗依从性差的患者，强调不治疗也可能是合理的、循证的临床决策。该指南进一步强调了生成反映韩国患者治疗经验的真实世界数据的迫切需求。多中心合作对于收集关于依从率、ARIA发生率、认知结果和功能轨迹的数据至关重要，这些数据反过来可以为政策决策、保险报销模式和临床指南的未来更新提供信息。本出版物代表了韩国首个全国性路线图，以支持临床医生适当整合用于AD的单克隆抗体疗法。通过结合科学严谨性、操作可行性和伦理敏感性，它旨在促进在各种临床环境中安全、负责任地采用疾病修饰治疗。
