药物开发 药物开发
Jack Taylor1, Paul Rolan1, Mark Jaros2
1Actinogen Medical, Sydney, Australia.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
概括
克萨纳 (Emestedastat) 通过降低大脑皮质醇,显示出治疗抑郁症的希望. 该药物在2期试验中显著改善了抑郁症状,验证了其治疗潜力.
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:
- 赞纳 (Emestedastat) 是一种口服的,有选择性的11β-HSD1抑制剂,向中枢神经系统皮质醇的产生.
- 临床研究表明,Xanamem在阿尔茨海默氏症 (AD) 和严重抑郁症 (MDD) 中具有潜力.
- 之前的试验显示了目标参与,健康成年人的认知能力改善,以及阿兹海默症患者减弱的衰退.
研究的目的:
- 评估Xanamem每天10毫克在患有MDD和认知缺陷的患者的疗效.
- 验证11β-HSD1抑制剂作为MDD的治疗标.
- 评估Xanamem在MDD患者群体中的安全性和耐受性.
主要方法:
- 一个第二阶段的双盲随机试验 (XanaCIDD),涉及165名MDD患者.
- 参与者接受了Xanamem 10mg或安慰剂6周,随后进行了4周的随访.
- 主要终点:注意力和工作记忆的Cogstate测试电池 (CTB);次要终点:MADRS,PGI-S.
主要成果:
- 两组之间主要认知终点 (CTB) 没有显著差异.
- 在修改后的治疗意图 (mITT) 群体中,在第10周的MADRS得分中观察到具有统计学意义的好处 (p<0.05).
- 从第二周开始,xanamem在PGI-S得分上显示出临床上有意义的益处,并趋向于更高的响应率 (p=0.08).
结论:
- 通过抑制11β-HSD1来控制中枢神经系统的皮质醇产生可能是治疗MDD的可行策略.
- 这些发现支持xanamem对MDD的治疗潜力,特别是与SSRI药物联合使用.
- 该研究验证了11β-HSD1目标和Xanamem每日10mg剂量的潜在临床用途.
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