TABLE 2.
Primary and secondary cognitive endpoints from baseline to 18 months, modified intention‐to‐treat population.
Intervention | Control | Difference between intervention and control groups | |||
---|---|---|---|---|---|
Cognitive composite score | Mean change (SE) | Mean change (SE) | Estimate (95% CI) | p value | Cohen's d |
Primary | |||||
Global composite score | 0.55 (0.04) | 0.39 (0.04) | 0.16 (0.04 to 0.27) | 0.009 | 0.38 |
Post hoc analysis | |||||
Attention | 0.32 (0.09) | 0.20 (0.09) | 0.12 (−0.10 to 0.35) | 0.28 | 0.16 |
Executive functioning Processing speed | 0.32 (0.06) | 0.16 (0.06) | 0.16 (0.02 to 0.30) | 0.03 | 0.37 |
Memory | 1.01 (0.07) | 0.83 (0.07) | 0.19 (0.01 to 0.37) | 0.04 | 0.29 |
Notes: The mixed model for repeated measures analyses assessed between‐group differences (group × time interaction) in the modeled changes from baseline to 18 months, based on data from all participants with at least one post‐baseline measurement. Scores on the global composite score, attention, executive functioning/processing speed, and memory‐domain scores were estimated as mean values (standard errors) of z‐scores of the cognitive tests included in each cognitive outcome, with higher scores indicating better performance. A positive value of the estimate of between‐group differences indicates that the effect favors the intervention group.
Abbreviations: CI, confidence interval; SE, standard error.