Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials
Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials
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DOI：
10.1001/archneur.61.1.59
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发表时间：
2004-01-01
影响因子：
--
通讯作者：
Thal, LJ
中科院分区：
文献类型：
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作者：
Grundman, M;Petersen, RC;Thal, LJ
背景资料：轻度认知功能障碍（MCI）是介于正常衰老和极早期痴呆之间的一种过渡状态，是阿尔茨海默病（AD）的危险因素。记忆损害研究（MIS）是一项在MCI患者中进行的多中心临床试验，旨在评估维生素E或多奈哌齐是否能有效延迟AD临床诊断的时间。目的：描述MIS招募的MCI患者的基线特征，并将其与另一项临床试验中的老年对照组和AD患者进行比较。设计：对参与多中心临床试验的MCI患者的描述性和比较性研究。设置：美国和加拿大的记忆障碍中心。患者：共769例MCI患者，107例认知正常老年对照，122例极轻度AD患者（临床痴呆评分[CDR] 0.5），并对183名轻度AD患者（CDR 1.0）进行了评估。MIS中的患者符合遗忘型MCI的操作标准。对照组与MCI组平行招募，进行相同的评估，CDR为0。主要结果测量：临床、神经心理学、功能、神经影像学和遗传学测量。阿尔茨海默病评估量表认知子量表的平均SD评分为对照组5.6 +/- 3.3，MCI患者11.3 +/- 4.4，AD CDR 0.5组为18.0 +/- 6.2，AD CDR 1.0组为25.2 +/- 8.8。与对照组相比，MCI患者在记忆任务上受损最严重，其他认知领域的受损程度较轻。MCI患者携带载脂蛋白E ε 4等位基因的可能性高于对照组，但低于AD患者。MCI患者的海马体积之间的控制和AD患者。结论：MCI患者有一个主要的记忆障碍与其他认知领域的相对保留和临床正常的个人和AD患者之间的认知和功能评级。这些结果表明，在一项多中心临床试验中，成功实施了这一独特的高危患者组的操作标准。
Background: Mild cognitive impairment (MCI) represents a transitional state between the cognitive changes of normal aging and very early dementia and is becoming increasingly recognized as a risk factor for Alzheimer disease (AD). The Memory Impairment Study (MIS) is a multicenter clinical trial in patients with MCI designed to evaluate whether vitamin E or donepezil is effective at delaying the time to a clinical diagnosis of AD.Objective: To describe the baseline characteristics of patients with MCI recruited for the MIS and compare them with those of elderly controls and patients with AD in another clinical trial.Design: Descriptive and comparative study of patients with MCI participating in a multicenter clinical trial.Setting: Memory disorder centers in the United States and Canada.Patients: A total of 769 patients with MCI, 107 cognitively normal elderly controls, 122 patients with very mild AD (Clinical Dementia Rating [CDR] 0.5), and 183 patients with mild AD (CDR 1.0) were evaluated. Patients in the MIS met operational criteria for amnestic MCI. Controls were recruited in parallel with the MCI group, underwent the same assessments, and had a CDR of 0.Main Outcome Measures: Clinical, neuropsychologic, functional, neuroimaging, and genetic measures.Results: Mean SD Alzheimer's Disease Assessment ScaleCognitive Subscale scores were 5.6 +/- 3.3 for controls, 11.3 +/- 4.4 for patients with MCI, 18.0 +/- 6.2 for the AD CDR 0.5 group, and 25.2 +/- 8.8 for the AD CDR 1.0 group. Compared with controls, patients with MCI were most impaired on memory tasks, with less severe impairments in other cognitive domains. Patients with MCI were more likely than controls but less likely than patients with AD to carry the apolipoprotein E epsilon4 allele. Patients with MCI had hippocampal volumes that were intermediate between those of controls and patients with AD.Conclusions: Patients with MCI had a predominant memory impairment with relative sparing of other cognitive domains and were intermediate between clinically normal individuals and patients with AD on cognitive and functional ratings. These results demonstrate the successful implementation of operational criteria for this unique group of at-risk patients in a multicenter clinical trial.