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. 2022 Sep;11(3):1085-1100.
doi: 10.1007/s40120-022-00352-w. Epub 2022 May 5.

Assessing the Clinical Meaningfulness of the Alzheimer's Disease Composite Score (ADCOMS) Tool

Amir Abbas Tahami Monfared  1   2 , William R Lenderking  3 , Yulia Savva  3 , Mary Kate Ladd  3 , Quanwu Zhang  4 ; Alzheimer’s Disease Neuroimaging Initiative
Collaborators, Affiliations

Assessing the Clinical Meaningfulness of the Alzheimer's Disease Composite Score (ADCOMS) Tool

Amir Abbas Tahami Monfared et al. Neurol Ther. 2022 Sep.

Abstract

Introduction: The Alzheimer's Disease Composite Score (ADCOMS) is a tool developed to detect clinical progression and measure treatment effect in patients in early stages of Alzheimer's disease (AD). The psychometric properties of the ADCOMS have been established; however, the threshold for clinical meaningfulness has yet to be identified.

Methods: Anchor-based, distribution-based, and ROC curve analyses were used to estimate clinically meaningful thresholds for change in ADCOMS for patients with mild cognitive impairment (MCI) and AD dementia. This study included data from three sources: the Alzheimer's Disease Neuroimaging Initiative (ADNI), the National Alzheimer's Coordinating Center (NACC), and a legacy dataset that included data from four sources: the placebo group from three MCI trials and an earlier data cut from ADNI. Results were stratified by disease severity (MCI vs. dementia) and APOE ε4 carrier status.

Results: A total of 5355 participants were included in the analysis. The ADCOMS was able to detect change for MCI and dementia patients who experienced a meaningful decline in cognition (as defined by the Clinical Dementia Rating Scale Sum of Boxes [CDR-SOB]) between baseline and month 12. The following ADCOMS cut-offs were proposed: 0.05 for MCI and 0.10 for dementia.

Conclusions: The ADCOMS was previously established as a valid and reliable tool for use in clinical trials for MCI due to AD and dementia populations. By defining thresholds for clinically meaningful change of ADCOMS, this work is an important step in interpreting clinical findings and estimates of treatment effects in early stage AD trials.

Keywords: Alzheimer’s disease; Clinically meaningful change; Composite measure; Dementia; Mild cognitive impairment.

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Figures

Fig. 1
Fig. 1
CDF plot of the change in ADCOMS score from baseline to month 12 by CDR-SOB for MCI patients. The dotted line indicates the proposed ADCOMS threshold for meaningful change for MCI (0.05). ADCOMS Alzheimer’s Disease Composite Score, CDF cumulative density function, CDR-SOB Clinical Dementia Rating Scale Sum of Boxes, MCI mild cognitive impairment
Fig. 2
Fig. 2
CDF plot of the change in ADCOMS score from baseline to month 12 by CDR-SOB for dementia patients. The dotted line indicates the proposed ADCOMS threshold for meaningful change for dementia (0.10). ADCOMS Alzheimer’s Disease Composite Score, CDF cumulative density function, CDR-SOB Clinical Dementia Rating Scale Sum of Boxes
See this image and copyright information in PMC

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