药物开发 药物开发
Melanie Shulman1, Shuang Wu1, Jing Xie1
1Biogen, Cambridge, MA, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
概括
这一第二阶段试验调查了BIIB080,一种反感性寡核酸,用于早期阿尔茨海默病 (AD). 该研究旨在减少病理,可能减缓轻度认知障碍或痴呆症患者的疾病进展.
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:
- 阿尔茨海默病 (AD) 治疗尽管使用粉样蛋白治疗,但仍有未满足的需求.
- 病理与阿尔茨海默病的临床损伤有很强的相关性.
- BIIB080是一种反感性寡核酸,向tau mRNA,以减少tau蛋白质的产生.
研究的目的:
- 评估BIIB080在AD早期的疗效,安全性和耐受性.
- 评估BIIB080在减少tau病理方面的剂量反应.
- 研究BIIB080对认知衰退和AD生物标志物的影响.
主要方法:
- 第2阶段,随机,双盲,安慰剂控制的研究 (CELIA,NCT05399888).
- 416名参与者患有早期老年痴呆症 (MCI或轻度痴呆症),年龄在50-80岁之间.
- 在76周内输入内BIIB080或安慰剂;主要终点:76.7周的CDR-SB变化.
主要成果:
- 第二阶段CELIA研究的招生已经完成.
- 初步基线特征与其他早期AD试验相似.
- 结果的完整描述将被介绍.
结论:
- 目前正在进行的CELIA试验将确定BIIB080的疗效和安全性与早期AD的安慰剂相比.
- 在之前的研究中,BIIB080在生物标志物上显示出有前途的效果.
- 这项试验对于推进阿尔茨海默病的定位疗法至关重要.
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