Abstract
Background. A short yet reliable cognitive measure is needed that separates treatment and placebo for treatment trials for Alzheimer’s disease. Hence, we aimed to shorten the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog) and test its use as an efficacy measure. Methods. Secondary data analysis of participant-level data from five pivotal clinical trials of donepezil compared with placebo for Alzheimer’s disease (N = 2,198). Across all five trials, cognition was appraised using the original 11-item ADAS-Cog. Statistical analysis consisted of sample characterization, item response theory (IRT) to identify an ADAS-Cog short version, and mixed models for repeated-measures analysis to examine the effect sizes of ADAS-Cog change on the original and short versions in the placebo versus donepezil groups. Results. Based on IRT, a short ADAS-Cog was developed with seven items and two response options. The original and short ADAS-Cog correlated at baseline and at weeks 12 and 24 at 0.7. Effect sizes based on mixed modeling showed that the short and original ADAS-Cog separated placebo and donepezil comparably (ADAS-Cog original ES = 0.33, 95% CI = 0.29, 0.40, ADAS-Cog short ES = 0.25, 95% CI =0.23, 0.34). Conclusions. IRT identified a short ADAS-cog version that separated donepezil and placebo, suggesting its clinical potential for assessment and treatment monitoring.
Original language | English |
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Article number | e19 |
Journal | European Psychiatry |
Volume | 67 |
Issue number | 1 |
DOIs | |
State | Published - 23 Feb 2024 |
Bibliographical note
Publisher Copyright:© The Author(s), 2024. Published by Cambridge University Press on behalf of European Psychiatric Association.
Keywords
- Alzheimer’s disease
- assessment
- clinical trials
- cognition
- item response theory
- psychometric
ASJC Scopus subject areas
- Psychiatry and Mental health