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作为认知与功能综合指标的iADRS:早期症状性阿尔茨海默病近期临床试验的心理测量学证据。

The iADRS as an integrated measure of cognition and function: Psychometric evidence from recent clinical trials in early symptomatic Alzheimer's disease.

作者信息

Atkins Alexandra S, Marquis Sarah, Creel Kristin, Meunier Juliette, Cano Stefan, Delbecque Laure, Shan Mingyang, Wessels Alette M

机构信息

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.

Modus Outcomes, (a THREAD Company), Cary, North Carolina, USA.

出版信息

Alzheimers Dement. 2025 Sep;21(9):e70656. doi: 10.1002/alz.70656.

DOI:10.1002/alz.70656
PMID:40947482
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12433759/
Abstract

INTRODUCTION

Psychometric evaluation of the integrated Alzheimer's Disease Rating Scale (iADRS) was performed using data from three randomized clinical trials (RCTs).

METHODS

Traditional measurement properties of the iADRS were assessed using classical test theory (CTT). Rasch Measurement Theory (RMT) analyses evaluated response properties of cognitive and functional items across the disease severity continuum. Crosswalks between iADRS, Clinical Dementia Rating - Sum of Boxes (CDR-SB), and Mini-Mental State Examination (MMSE) were developed to provide estimates of score equivalence.

RESULTS

CTT results confirm good psychometric properties of the iADRS, including reliability (Cronbach's alpha 0.79-0.84), concurrent validity with CDR-SB (range: -0.64-0.70), and sensitivity to change. RMT findings demonstrate improved reliability of the integrated scale (person-separation index [PSI] = 0.92) compared to components and highlight concurrent and overlapping progression of cognitive and functional decline.

DISCUSSION

The findings confirm the psychometric strength of the iADRS as a fit-for-purpose integrated endpoint for RCTs in early symptomatic Alzheimer's disease (AD). Crosswalk tables facilitate interpretation of clinical trial findings in clinical practice.

HIGHLIGHTS

Findings confirm integrated Alzheimer's Disease Rating Scale (iADRS) total score reliability, validity, and sensitivity. Using the Rasch Measurement Theory (RMT), iADRS item set shows improved reliability relative to its component subscales. iADRS item thresholds are well distributed along the disease severity continuum. iADRS shows sensitivity to concurrent progression of cognitive and functional impairment. Crosswalk tables provide direct translation between iADRS, Clinical Dementia Rating - Sum of Boxes (CDR-SB), and Mini-Mental State Examination (MMSE).

摘要

引言

使用来自三项随机临床试验(RCT)的数据对整合型阿尔茨海默病评定量表(iADRS)进行了心理测量学评估。

方法

使用经典测验理论(CTT)评估iADRS的传统测量特性。拉施测量理论(RMT)分析评估了疾病严重程度连续体上认知和功能项目的反应特性。制定了iADRS、临床痴呆评定量表-方框总和(CDR-SB)和简易精神状态检查表(MMSE)之间的对照表,以提供分数等效性估计。

结果

CTT结果证实iADRS具有良好的心理测量特性,包括信度(克朗巴哈系数α为0.79 - 0.84)、与CDR-SB的同时效度(范围:-0.64 - 0.70)以及对变化的敏感性。RMT研究结果表明,与各分量表相比,整合量表的信度有所提高(个人分离指数[PSI]=0.92),并突出了认知和功能衰退的同时性和重叠性进展。

讨论

研究结果证实了iADRS作为早期症状性阿尔茨海默病(AD)RCTs适用的整合终点的心理测量优势。对照表有助于在临床实践中解释临床试验结果。

要点

研究结果证实了整合型阿尔茨海默病评定量表(iADRS)总分的信度、效度和敏感性。使用拉施测量理论(RMT),iADRS项目集相对于其分量表显示出更高的信度。iADRS项目阈值在疾病严重程度连续体上分布良好。iADRS显示出对认知和功能损害同时进展的敏感性。对照表提供了iADRS、临床痴呆评定量表-方框总和(CDR-SB)和简易精神状态检查表(MMSE)之间的直接转换。

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本文引用的文献

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J Prev Alzheimers Dis. 2025 Apr;12(4):100101. doi: 10.1016/j.tjpad.2025.100101. Epub 2025 Mar 4.
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Appropriate use of meaningful within-patient change (MWPC) thresholds in Alzheimer's disease.阿尔茨海默病中患者内有意义变化(MWPC)阈值的合理应用。
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Care partner-informed meaningful change thresholds for the Clinical Dementia Rating-Sum of Boxes for trials of early Alzheimer's disease.用于早期阿尔茨海默病试验的临床痴呆评定量表-框总数的照顾者知情有意义的变化阈值。
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Preparing for disease-modifying therapies in Alzheimer's disease.为阿尔茨海默病的疾病修饰治疗做准备。
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