药物开发 药物开发
Michael Grundman1, Susan Catalano2, Mary E Hamby3
1Global R&D Partners, LLC, La Jolla, CA, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
概括
泽维米塞因在减缓阿尔茨海默病患者的认知衰退方面表现有前途. 较低的疾病负担,以血p-tau217表示,与SHINE试验中更显著的积极治疗效果相关.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 泽维米素 (CT1812) 是一种实验性口服药物,向粉样β寡合体.
- 它旨在保护阿尔茨海默氏症 (AD) 和患有莱维体痴呆症的神经突触.
研究的目的:
- 评估成年轻度至中度AD的泽维美素的耐受性和临床效应.
- 根据血p-tau217水平来评估与安慰剂相对的治疗效应.
主要方法:
- 第二阶段的SHINE临床试验随机选择了153名患有粉样蛋白阳性AD的成年人.
- 参与者每天接受安慰剂或泽维梅辛 (100或300毫克) 26周.
- 认知和功能评估包括ADAS-Cog,MMSE,ADSC-ADL和CGIC. 这些测试包括:
主要成果:
- 与安慰剂相比,在ADAS-Cog 11治疗中,泽维米塞因治疗减少了认知衰退39%,在MMSE治疗中减少了70%.
- 血p-tau217水平低于中位数的患者表现出更强的反应,ADAS-Cog 11下降率降低95%,MMSE下降率降低108%.
- 这种增强的反应在不同基线MMSE严重程度范围内是一致的.
结论:
- 泽维梅西因在阿尔茨海默病患者的认知衰退减缓方面显示出潜力.
- 较低的疾病负担,以血p-tau217表示,预测更明显的治疗效果.
- 该药物在轻度至中度MMSE频谱中显示出好处,这表明中度AD患者的治疗窗口.
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