在基于人群的认知衰老研究中,认知和功能结果的临床意义上的变化
Jeremiah A Aakre1, Anna M Castillo1, Jonathan Graff-Radford2
1Department of Quantitative Health Sciences Mayo Clinic Rochester Minnesota USA.
Alzheimer's & dementia (New York, N. Y.)
|September 26, 2025
概括
这项研究确定了轻度认知障碍 (MCI) 患者认知和功能评估的有意义的变化值. 这些发现对于评估阿尔茨海默病和相关痴呆症临床试验至关重要.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 关于阿尔茨海默病和相关痴呆症 (ADRD) 临床结果评估 (COA) 的有意义变化值的数据有限.
- 确定这些值对于解释早期疾病的结果至关重要,特别是在基于人口的研究中.
研究的目的:
- 确定对认知和功能性COA具有临床意义的患者内变化值.
- 为ADRD临床试验的社区样本提供早期疾病进展的估计.
主要方法:
- 在基于人口的梅奥诊所衰老研究 (MCSA) 中,利用了来自646名参与者的数据 (年龄为54至99岁).
- 建立患者内部的变化值,以发生轻度认知障碍 (MCI) 的诊断为点.
- 分析了临床痴呆症评分 (CDR) 尺度框总和 (SB),迷你精神状态检查 (MMSE) 和功能活动问卷 (FAQ) 成绩的变化.
主要成果:
- 年化平均变化为:CDR-SB 0.49,MMSE -1.01,和常见问题 1.04.
- 为这些估计提供了95%的置信区间,表明了统计学意义.
结论:
- 这项研究为早期ADRD进展中临床上有意义的变化提供了必要的患者内估计.
- 这些门可以帮助规划和评估疾病修饰疗法 (DMT) 临床试验.
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