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轻度至中度阿尔茨海默病患者的低剂量互白素-2:一项随机临床试验
Alireza Faridar1,2, Nazaret Gamez3, Daling Li3
1Stanley H. Appel Department of Neurology, Houston Methodist Research Institute, Houston, TX, 77030, USA. afaridar@houstonmethodist.org.
Alzheimer's research & therapy
|July 4, 2025
概括
对阿尔茨海默氏病 (AD) 患者来说,低剂量介素-2 (IL-2) 治疗是安全的. 每4周一次的剂量方案扩大了调节性T细胞 (Tregs),改善了生物标志物,并显示出减缓疾病进展的潜力.
科学领域:
- 免疫学 免疫学 免疫学
- 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.
背景情况:
- 调节性T细胞 (Tregs) 功能障碍有助于阿尔茨海默氏症 (AD) 的炎症状态.
- Tregs代表了恢复AD免疫平衡的潜在治疗标.
- 在AD个体中研究低剂量的干白素-2 (IL-2) 对Treg扩张的研究.
研究的目的:
- 评估两种低剂量IL-2剂量频率在扩大Tregs中的安全性和有效性.
- 评估IL-2对阿尔茨海默氏症疾病进展标志物的影响.
主要方法:
- 2a期,随机,双盲,安慰剂对照研究,38名参与者.
- 皮下IL-2 (10^6 IU/天) 每4周一次 (IL-2 q4wks) 或每2周一次 (IL-2 q2wks) 与安慰剂相比,每21周一次.
- 主要终点:不良事件. 二级:Treg编号和功能. 探索性:炎症调解剂,CSF生物标志物和临床尺度.
主要成果:
- 两种IL-2疗法都安全且耐受良好;没有报告严重不良事件.
- 与IL-2 q4wks和安慰剂相比,IL-2 q4wks表现出优异的Treg扩张和增强的抑制功能.
- IL-2 q4wks显著改善了CSF Aβ42水平,稳定了CSF NfL,并趋向于缓慢认知衰退 (ADAS-cog).
结论:
- 低剂量IL-2免疫疗法在AD患者扩大Tregs方面是安全有效的.
- 该IL-2 q4wks疗法调节了炎症介质和AD的关键生物标志物.
- 这些发现支持进一步研究IL-2作为阿尔茨海默病潜在的疾病修饰疗法.
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