Wessels Alette M, Rentz Dorene M, Case Michael, Lauzon Steve, Sims John R
Eli Lilly and Company Indianapolis Indiana USA.
Department of Neurology Massachusetts General Hospital, Harvard Medical School Boston Massachusetts USA.
Alzheimers Dement (N Y). 2022 Jun 6;8(1):e12312. doi: 10.1002/trc2.12312. eCollection 2022.
The Integrated Alzheimer's Disease Rating Scale (iADRS) has been used to detect differences in disease progression in early Alzheimer's disease (AD). The objectives of this study were to enhance understanding of iADRS point changes within the context of clinical trials, and to establish a minimal clinically important difference (MCID) on the iADRS.
Data from AMARANTH and EXPEDITION3 were analyzed using various approaches, including anchor-based, distribution-based, regression analyses, and cumulative distribution function (CDF) plots. Three potential anchors were examined, including the Clinical Dementia Rating-Sum of Boxes, Mini-Mental State Examination, and Functional Activities Questionnaire. Triangulation of all results was used to determine the MCID for participants with mild cognitive impairment (MCI) due to AD and AD with mild dementia.
All three anchors met criteria for "sufficiently associated" (|r| = 0.4-0.7). Cumulatively, results from anchor-based and distribution-based results converged to suggest an iADRS MCID of 5 points for MCI due to AD and 9 points for AD with mild dementia. Regression analyses and CDF plots supported these values.
These findings suggest the iADRS can be used in clinical trials to detect a clinically meaningful outcome of AD progression.
综合阿尔茨海默病评定量表（iADRS）已被用于检测早期阿尔茨海默病（AD）疾病进展的差异。本研究的目的是在临床试验背景下加深对iADRS评分变化的理解，并确定iADRS的最小临床重要差异（MCID）。
使用多种方法分析了来自AMARANTH和EXPEDITION3的数据，包括基于锚定法、基于分布法、回归分析和累积分布函数（CDF）图。研究了三个潜在的锚定指标，包括临床痴呆评定量表-方框总和、简易精神状态检查表和功能活动问卷。所有结果的三角测量法用于确定因AD导致轻度认知障碍（MCI）的参与者以及患有轻度痴呆的AD患者的MCID。
所有三个锚定指标均符合“充分相关”标准（|r| = 0.4 - 0.7）。总体而言，基于锚定法和基于分布法的结果趋于一致，表明因AD导致MCI的iADRS MCID为5分，患有轻度痴呆的AD患者为9分。回归分析和CDF图支持这些值。
这些发现表明iADRS可用于临床试验，以检测AD进展的具有临床意义的结果。
