P3‐391: Effectiveness of galantamine in patients with mild‐to‐moderate dementia: 12 months' outcome data

ment effects on language were evaluated using the SIB-L (score range 0-41; higher scores reflect greater language function) in the overall US subgroup, in the cohort of US-based patients with more advanced AD at baseline (MMSE 0-16), and in US-based patients stratified by concomitant memantine use. Results: In the overall US subgroup ITT population (N1⁄4433), the change in SIB-L score from baseline to Week 24 favored donepezil 23 mg/ day over 10 mg/day (LSmean [SE]: +0.4 [0.25] vs. -1.1 [0.37], LOCF; treatment difference: 1.4 [95% CI: 0.57, 2.32], p1⁄40.0013). Similar benefits favoring donepezil 23 mg/day were observed in the cohort of patients with more advanced AD at baseline (n1⁄4330; treatment difference: 1.7 [95% CI: 0.62, 2.77], p1⁄40.0021) and in patients taking concomitant memantine (n1⁄4326; treatment difference: 1.5 [95%CI: 0.54, 2.56], p1⁄40.0028). Numerical benefits in favor of donepezil 23 mg/day were also observed in the US-based patients not taking concomitant memantine (n1⁄4107; treatment difference: 1.1 [95% CI: -0.63, 2.93]). Conclusions: In this post hoc subgroup analysis of US-based patients with moderate-to-severe AD, donepezil 23 mg/day provided statistically significant incremental language benefits over donepezil 10 mg/day, as measured using the SIB-L. These results mirror those reported for the overall global study population and further support donepezil 23 mg/day as a meaningful treatment option for patients with moderate-to-severe AD, for whom language preservation is especially important.