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EXPEDITION3 试验中的综合阿尔茨海默病评定量表(iADRS)研究结果。

The Integrated Alzheimer's Disease Rating Scale (iADRS) Findings from the EXPEDITION3 Trial.

机构信息

Alette Wessels, Eli Lilly and Company, Indianapolis IN 46285, USA, E-mail:

出版信息

J Prev Alzheimers Dis. 2018;5(2):134-136. doi: 10.14283/jpad.2018.10.

Abstract

The Integrated Alzheimer's Disease (AD) Rating Scale (iADRS) is a composite tool that combines scores from the AD Assessment Scale-Cognitive subscale (ADAS-Cog) and the AD Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL). It demonstrates acceptable psychometric properties, and is effective in capturing both disease progression and separation of placebo and active drug effect. We assessed the performance of iADRS in the solanezumab EXPEDITION3 study, an 80-week, placebo-controlled study of individuals with mild AD dementia. A statistically significant difference between placebo and active drug was observed for iADRS score change from baseline at Week 28 (p=0.028) through Week 80 (p=0.015). Across the Phase 3 solanezumab trials, iADRS was the only tool that consistently differentiated between solanezumab and placebo groups. These findings suggest that the iADRS is a useful integrated measurement tool for treatment trials of individuals with mild AD dementia.

摘要

一体化阿尔茨海默病(AD)评定量表(iADRS)是一种综合工具,它结合了 AD 评估量表认知子量表(ADAS-Cog)和 AD 合作研究-日常活动工具量表(ADCS-iADL)的评分。它具有可接受的心理测量学特性,能有效地捕捉疾病进展和安慰剂与活性药物效果的分离。我们评估了 iADRS 在 solanezumab EXPEDITION3 研究中的表现,该研究是一项为期 80 周、安慰剂对照的轻度 AD 痴呆患者研究。从基线到第 28 周(p=0.028)和第 80 周(p=0.015),iADRS 评分变化与安慰剂相比,观察到有统计学意义的差异。在整个 3 期 solanezumab 试验中,iADRS 是唯一能在 solanezumab 组和安慰剂组之间进行区分的工具。这些发现表明,iADRS 是轻度 AD 痴呆患者治疗试验的一种有用的综合测量工具。

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