Donepezil treatment of patients with MCI

多奈哌齐 安慰剂 临床全球印象 医学 不利影响 临床终点 临床试验 临床痴呆评级 评定量表 认知 心理学 内科学 精神科 痴呆 替代医学 疾病 发展心理学 病理
作者
Rachelle S. Doody,Steven Ferris,Stephen Salloway,Yingtong Sun,Robert Goldman,W. E. Watkins,Yichen Xu,Anita Murthy
出处
期刊:Neurology [Ovid Technologies (Wolters Kluwer)]
卷期号:72 (18): 1555-1561 被引量:162
标识
DOI:10.1212/01.wnl.0000344650.95823.03
摘要

Background: Treatment of mild cognitive impairment (MCI) with cholinesterase inhibitors may improve symptoms. Methods: In this multicenter, randomized, placebo-controlled trial, subjects with MCI entered a 3-week placebo run-in period followed by 48 weeks of double-blind donepezil (5 mg/day for 6 weeks, then 10 mg/day for 42 weeks) or placebo treatment. Primary efficacy variables included change from baseline in the modified Alzheimer Disease Assessment Scale–cognitive subscale (ADAS-Cog) and Clinical Dementia Rating Scale–sum of boxes (CDR-SB) after 48 weeks of treatment (modified intention-to-treat analysis). Secondary efficacy measures evaluated cognition, behavior, and function. Results: The dual primary efficacy endpoint was not reached. We noted a small, but significant, decrease in modified ADAS-Cog scores in favor of donepezil at study endpoint. Little change from baseline in CDR-SB and secondary variables was observed for either group. Patient Global Assessment scores favored donepezil at all time points except week 12 (p ≤ 0.05). Perceived Deficits Questionnaire scores favored donepezil at week 24 (p = 0.05). Clinical Global Impression of Change–MCI scores favored donepezil only at week 6 (p = 0.04). Adverse events were generally mild or moderate. More donepezil-treated subjects (18.4%) discontinued treatment due to adverse events than placebo-treated subjects (8.3%). Conclusions: Donepezil demonstrated small but significant improvement on the primary measure of cognition but there was no change on the primary measure of global function. Most other measures of global impairment, cognition, and function were not improved, possibly because these measures are insensitive to change in MCI. Responses on subjective measures suggest subjects perceived benefits with donepezil treatment.
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