The clinical meaningfulness of ADAS-Cog changes in Alzheimer's disease patients treated with donepezil in an open-label trial
The clinical meaningfulness of ADAS-Cog changes in Alzheimer's disease patients treated with donepezil in an open-label trial
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DOI：
10.1186/1471-2377-7-26
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发表时间：
2007-08-30
期刊：
影响因子：
2.6
通讯作者：
Graham, Janice E.
中科院分区：
文献类型：
--
作者：
Rockwood, Kenneth;Fay, Sherri;Graham, Janice E.
背景：在为期6个月的抗痴呆药物试验中，阿尔茨海默病评估量表-认知子量表(ADAS-Cog)中4分的变化被认为具有重要的临床意义。方法：这是一项为期12个月的开放式研究的二次分析，研究对象为100名被诊断为轻至中度AD的患者(71名女性)，每天服用5-10 mg多奈哌齐。我们研究了观察病例，ADAS-Cog与基线相比6个月的变化，临床医生基于面谈的改变加照顾者输入印象(CIBIC-Plus)，患者目标实现程度量表(PGAS)和临床医生-GAS(CGAS)。结果：在6个月时，接受多奈哌齐治疗的患者(n=95)ADAS-Cog无变化(+/-3分)的可能性(56%)高于改善(20%)或下降(24%)4分的可能性(20%)或下降(24%)。ADAS-Cog变化评分与其他指标几乎没有相关性：从-0.09(PGAS)到0.27(Cibic-Plus)。虽然ADAS-Cog改善的患者在临床指标上下降的可能性较小(26%)，但在ADAS-Cog下降的患者中，43%的患者至少在两项临床指标上有所改善。结论：ADAS-Cog并未涵盖所有临床重要影响。总体而言，ADAS-Cog改善表明临床改善，而许多ADAS-Cog下降的人没有表现出临床下降。这项研究的开放标签设计不能让我们知道这是否是治疗效果，这需要进一步的研究。
Background: In 6-month anti-dementia drug trials, a 4-point change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale ( ADAS-Cog) is held to be clinically important. We examined how this change compared with measures of clinical meaningfulness.Methods: This is a secondary analysis of a 12 month open-label study of 100 patients ( 71 women) diagnosed with mild to moderate AD treated with 5 - 10 mg of donepezil daily. We studied the observed case, 6-month change from baseline on the ADAS-Cog, the Clinician's Interview Based Impression of Change- Plus Caregiver Input ( CIBIC-Plus), patient-Goal Attainment Scaling ( PGAS) and clinician-GAS (CGAS).Results: At 6 months, donepezil-treated patients (n = 95) were more likely to show no change (+/ - 3 points) on the ADAS-Cog ( 56%) than to improve (20%) or decline (24%) by 4-points. ADAS-Cog change scores were little correlated with other measures: from - 0.09 for PGAS to 0.27 for the CIBIC-Plus. While patients who improved on the ADAS-Cog were less likely to decline on the clinical measures (26%), 43% of patients who declined on the ADAS-Cog improved on at least two of the clinical measures.Conclusion: The ADAS-Cog did not capture all clinically important effects. In general, ADAS-Cog improvement indicates clinical improvement, whereas many people with ADAS-Cog decline do not show clinical decline. The open-label design of this study does not allow us to know whether this is a treatment effect, which requires further investigation.