关键词: Alzheimer's disease clinical trial methodology practice effects psychometrics

来  源:   DOI:10.1002/alz.13757

Abstract:
BACKGROUND: This study derived composite scores for two novel cognitive measures, the No Practice Effect (NPE) battery and the Miami Computerized Functional Skills Assessment and Training system for use in early-stage Alzheimer\'s disease (AD) clinical trials. Their psychometric properties and associations with AD risk markers were compared to those of well-established measures.
METHODS: For 291 older adults with healthy cognition or early mild cognitive impairment, Exploratory factor analyses were used to identify the factor structure of the NPE. Factor and total scores were examined for their psychometric properties and associations with AD risk biomarkers.
RESULTS: Composite scores from the novel cognitive and functional measures demonstrated better psychometric properties (distribution and test-retest reliability) and stronger associations with AD-related demographic, genetic, and brain risk markers than well-established measures, DISCUSSION: These novel measures have potential for use as primary cognitive and functional outcomes in early-stage AD clinical trials.
CONCLUSIONS: Well-established cognitive tests may not accurately detect subtle cognitive changes. No Practice Effect (NPE) and Computerized Functional Skills Assessment and Training are novel measures designed to have improved psychometric properties. NPE had Executive Function, Cognitive Control/Speed, and Episodic Memory domains. Novel measures had better psychometric properties compared to established measures. Significant associations with Alzheimer\'s disease biomarkers were found with novel measures.
摘要:
背景:这项研究得出了两种新颖的认知测量的综合得分,无实践效应(NPE)电池和迈阿密计算机功能技能评估和培训系统,用于早期阿尔茨海默病(AD)临床试验。将其心理测量特性以及与AD风险标志物的关联与已建立的指标进行了比较。
方法:对于291名认知健康或早期轻度认知障碍的老年人,探索性因子分析用于确定NPE的因子结构。检查了因子和总分的心理测量特性以及与AD风险生物标志物的关联。
结果:新的认知和功能测量的综合得分显示出更好的心理测量特性(分布和重测可靠性)以及与AD相关的人口统计学更强的关联,遗传,和大脑风险标志物比既定的措施,讨论:这些新的措施有可能用作早期AD临床试验的主要认知和功能结果。
结论:完善的认知测试可能无法准确检测到细微的认知变化。无实践效果(NPE)和计算机功能技能评估和培训是旨在改善心理测量特性的新颖措施。NPE具有执行功能,认知控制/速度,和情景记忆域。与既定措施相比,新措施具有更好的心理测量特性。通过新的措施发现了与阿尔茨海默病生物标志物的显着关联。
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