休息状态功能磁共振成像在阿尔茨海默病随机临床试验中的阿尔茨海默病
David Clayton1, Alexandre Coimbra1, Farshid Faraji1
1Genentech, Inc., Research and Early Development, 1 DNA Way, South San Francisco, CA, 94080, USA.
Neuroimage. Reports
|June 26, 2025
概括
休息状态功能连接在纵向研究中没有检测到阿尔茨海默病的进展. 随着时间的推移,个体内的测量变化是这种神经成像生物标志物的首要关注点.
科学领域:
- 神经科学是一个神经科学.
- 医疗成像医学成像
- 临床试验 临床试验
背景情况:
- 休息状态功能连接 (rsFC) 用于研究阿尔茨海默病 (AD) 和认知变化.
- 之前的rsFC研究经常使用单扫描器,单扫描数据,限制了概括性.
- 多中心,纵向数据对于AD中稳健的生物标志物验证至关重要.
研究的目的:
- 评估rsFC作为阿尔茨海默病进展的生物标志物的稳定性和敏感性.
- 为了评估rsFC在多中心,纵向设置中的测试-重新测试可重复性.
- 在纵向rsFC研究中识别测量变量的来源.
主要方法:
- 利用了来自两项随机临床试验的副研究的数据,这些临床试验对患有轻度至中度阿尔茨海默氏症的患者进行.
- 通过使用标准化成像协议在多个站点获取rsFC数据.
- 在8周间隔内分析了安慰剂组的rsFC,临床分数和区域大脑缩的纵向变化.
主要成果:
- 随着时间的推移,在安慰剂组中没有观察到 rsFC 的显著变化,尽管临床下降和大脑缩.
- rsFC的试验-复试可重复性与现有文献相比较.
- 随着时间的推移,个体内部的变化是测量误差的主要来源,超过了个体间和地点间的变化.
结论:
- 实施的rsFC可能缺乏检测轻度至中度阶段阿尔茨海默病进展的灵敏度.
- 高个体内变异性对AD的纵向rsFC分析构成了挑战.
- 建议采用视觉检查方法来提高纵向rsFC数据的质量.
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