XXXX treatment in severe @entity195 : a pooled analysis of three clinical trials.

@entity1 @entity8124 @entity195
OBJECTIVE: Individual clinical trials have demonstrated benefits of @entity8124 in @entity1 with severe @entity195 ( @entity195 ). Data were pooled from three randomized, placebo-controlled trials of @entity8124 for severe @entity195 to further evaluate treatment effects and overall tolerability/safety. METHODS: Total scores and sub-scores were analyzed for measures of cognition, global function, function, and behavior. Additional analyses were performed to investigate (1) relationships between cognitive, functional, and behavioral changes, and (2) patterns of combined domain response. RESULTS: Using pooled total scores, significant treatment differences at endpoint in favor of @entity8124 were observed for cognition, global function (both p < 0.0001), and function (p = 0.03), with an effect size (Cohen's d) of 0.51, 0.26, and 0.17, respectively. There was no significant treatment difference for behavior. However, @entity8124 -treated @entity1 with stabilized/improved cognition tended to show significant improvements in function and behavior over placebo-treated @entity1 . @entity1 treated with @entity8124 were 2-3 times more likely to achieve a combined domain response than placebo-treated @entity1 (p < 0.0001). Adverse events were as expected for cholinergic therapy, and mortality rates were similar between the treatment groups. CONCLUSIONS: These findings suggest measurable @entity8124 -mediated symptomatic benefits in cognition, global function, and daily living activities in @entity1 with severe @entity195 . The treatment effects support the importance of cholinesterase inhibition as a clinically relevant therapeutic option across the spectrum of @entity195 .
