医学
痴呆
评定量表
神经影像学
临床痴呆评级
齿轮
认知
内科学
队列
疾病
心理学
精神科
计算机科学
人工智能
发展心理学
作者
Anette Schrag,Jonathan M. Schott
标识
DOI:10.1136/jnnp-2011-300881
摘要
Objective
To establish the minimal clinically relevant change (MCRC) on the Alzheimer9s Disease Assessment Scale-Cognitive (ADAS-Cog) for patients with mild Alzheimer9s disease (AD). Design
Cohort study. Setting
59 recruiting sites for the Alzheimer9s Disease Neuroimaging Initiative. Patients
Outpatients with AD in the Alzheimer9s Disease Neuroimaging Initiative. Main outcome measures
The authors applied anchor-based MCRC methodology comparing ADAS-Cog change against clinicians9 judgement of clinically relevant worsening between baseline and 6 months in four domains: memory and non-memory cognitive performance; Clinical Dementia Rating Scale; and Functional Assessment Questionnaire. The analysis was repeated for the 6–12-month interval. To support these findings, the authors calculated distribution-based measures including half-baseline SD (1/2 SD) and SEM. Results
181 patients (baseline ADAS-Cog score 18.5±6.4) had ADAS-Cog data at 0 and 6 months. Those undergoing clinically significant worsening on any of the four anchor questions (n=41–47) had an average ADAS-Cog change of 3.1–3.8 points. Similar results were found for the 177 patients with 6–12-month data. The average 1/2 SD for the baseline ADAS-Cog score was 3.2, and the SEM was 3.7. Conclusions
3 points decline on the ADAS-Cog may be an appropriate MCRC for clinical trials of patients with early AD. However, further studies assessing the MCRC for improvement on the ADAS-Cog, using patient-based judgement as an anchor, and determining the minimal clinically relevant difference between change on two treatments are required. Clinical trial registration number
http://clinicalTrials.gov Identifier: NCT00106899.
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