药物开发 药物开发
Jin Zhou1, Erica Andreozzi1, Jorge J Llibre-Guerra2
1Eisai Inc., Nutley, NJ, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
概括
在主导性遗传性阿尔茨海默病 (DIAD) 患者中,莱卡内马布治疗通常在六个月内耐受良好. 常见的副作用包括粉样蛋白相关成像异常 (ARIA) 和输液反应,大多数病例为轻度至中度.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 研究主要遗传性阿尔茨海默病 (DIAD) 的治疗方法.
- 评估与lecanemab结合使用的etalanetug (E2814) 的使用情况.
- 在DIAN-TU-001试验中评估DIAD患者的lecanemab安全性.
研究的目的:
- 评估lecanemab在症状DIAD参与者的6个月安全性概况.
- 为了在这个人群中确定与lecanemab治疗相关的常见不良事件.
- 为了监测粉样蛋白相关的成像异常 (ARIA) 和输液反应.
主要方法:
- 第二阶段/第三阶段多中心,随机,双盲,安慰剂控制平台试验.
- 安全性评估包括生命体征,体检,不良事件,实验室测试和心电图.
- 磁共振成像 (MRI) 用于监测ARIA发生.
主要成果:
- 在97名DIAD参与者中,Lecanemab在6个月的时间内被耐受良好.
- 最常见的不良事件 (AE) 是ARIA-H (26.8%),头痛 (25.8%),ARIA-E (20.6%),以及输液反应 (11.3%).
- 有症状的ARIA-E发生在4.1%,有症状的ARIA-H发生在1.0%;2.06%因ARIA而退出.
结论:
- 莱卡尼马布在研究的DIAD人群中表现出良好的耐受性.
- ARIA-H,头痛,ARIA-E和输液反应是最常见的副作用.
- 患有DIAD的患者可能会出现与大脑粉样血管病变相关的ARIA的更高率.
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