A neuropsychological test battery for use in Alzheimer disease clinical trials
A neuropsychological test battery for use in Alzheimer disease clinical trials
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DOI：
10.1001/archneur.64.9.1323
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发表时间：
2007-09-01
影响因子：
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通讯作者：
Grundman, Michael
中科院分区：
文献类型：
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作者：
Harrison, John;Psychol, C.;Grundman, Michael
目的：为了报告阿尔茨海默病评估量表的认知子量表的替代工具的心理测量学特性，阿尔茨海默病评估量表是一种用于测量阿尔茨海默病临床试验中药物疗效的神经心理学测试组合（NTB）。设计：在一项随机、双盲、AN 1792（QS-21）（合成β-淀粉样蛋白加佐剂）（300例患者）和等渗氯化钠溶液（72例患者）的安慰剂对照试验。NTB的测试可靠性进行了检查，NTB与其他认知（阿尔茨海默病评估量表和简易精神状态检查的认知子量表）和功能（痴呆症残疾评估量表和临床痴呆症评分总和）措施。此外，还对非关税壁垒的构成部分进行了因子分析。最后，NTB的变化的敏感性进行了评估，作为一个功能的简易精神状态Examination.Results：NTB有较高的重测信度在6（皮尔逊积矩相关[r]=0.92）和12（r=0.88）个月。内部一致性较高（Cronbach α = 0.84）。NTB z得分与传统认知和功能测量得分之间的相关性与0有显著差异（P < .001）。因子分析得出了“记忆”和“执行功能”的因素。在接受安慰剂的患者中，NTB z评分在1年内线性下降，并且与阿尔茨海默病评估量表认知子量表相反，在基线时具有高（21- 26）和低（15- 20）简易精神状态检查评分的患者中表现出类似的下降。NTB表现出良好的心理测量特性，似乎是一个可靠的和敏感的措施，轻度至中度阿尔茨海默病患者的认知变化。NTB的心理测量特性表明，它可能具有特殊的效用，在临床试验中，轻度阿尔茨海默病患者包括在评估药物疗效。
Objective: To report the psychometric properties of an alternative instrument to the cognitive subscale of the Alzheimer's Disease Assessment Scale, a neuropsychological test battery (NTB) for measuring drug efficacy in Alzheimer disease clinical trials.Design: The NTB was evaluated in a randomized, doubleblind, placebo-controlled trial of AN1792(QS-21) ( synthetic beta-amyloid plus an adjuvant) ( 300 patients) and isotonic sodium chloride solution ( 72 patients). The testretest reliability of the NTB was examined, and the NTB was correlated with other cognitive ( cognitive subscale of the Alzheimer's Disease Assessment Scale and Mini-Mental State Examination) and functional ( Disability Assessment Scale for Dementia and Clinical Dementia Rating Sum of Boxes) measures. In addition, a factor analysis was performed on NTB components. Finally, the sensitivity of the NTB to change was assessed as a function of Mini-Mental State Examination performance.Results: The NTB had high test-retest reliability at 6 ( Pearson product moment correlation [r]=0.92) and 12 (r=0.88) months. Internal consistency was high (Cronbach alpha= 0.84). The correlations between the NTB z score and scores on traditional measures of cognition and function were significantly different from 0 ( P < .001). A factor analysis yielded "memory" and "executive function" factors. The NTB z score declined linearly over 1 year in patients receiving placebo and, in contrast to the Alzheimer's Disease Assessment Scale cognitive subscale, demonstrated similar declines in patients with high (21- 26) and low (15- 20) Mini-Mental State Examination scores at baseline.Conclusions: The NTB exhibits excellent psychometric properties and seems to be a reliable and sensitive measure of cognitive change in patients with mild to moderate Alzheimer disease. The psychometric properties of the NTB suggest that it may have particular utility in evaluating drug efficacy in clinical trials in which patients with mild Alzheimer disease are included.