Why carry out this study?

To assess treatment effects in clinical trials for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD), the FDA recommended the use of a composite measure. Following this recommendation, Eisai developed and validated the Alzheimer’s Disease Composite Score (ADCOMS).

Although the psychometric properties of the ADCOMS have been established, the threshold for clinical meaningfulness has yet to be identified. The objective of this study was to identify that threshold.

What was learned from the study?

Based on a triangulation evaluating the range of estimates for meaningful change, the following cut-off points for meaningful change were proposed: 0.05 for MCI and 0.10 for dementia.

By establishing the thresholds for clinically meaningful change, researchers can more confidentially use the ADCOMS as an outcome measure for clinical trials in MCI due to AD and for dementia.