Primary efficacy analysis
cognitive deterioration
SECONDARY
Masitinib (4.5 mg/kg/day) showed significant benefit relative to placebo over 24 weeks on the endpoint of ADAS-cog, with a δADAS-cog of −1.46 (representing an overall improvement in cognition) versus +0.69 (representing increased cognitive deterioration), respectively, and corresponding ΔADAS-cog of −2.15 (97.5%CI [−3.48, −0.81]); Jump-to-reference and multiple imputation sensitivity analyses confirmed the study’s primary objective was achieved for the primary endpoint of ADAS-cog, with a significant ΔADAS-cog of −1.86 (95%CI [(−3.03, −0.69]; Summary of efficacy results for primary analysis, sensitivity analyses, and secondary endpoints (responder analyses) for the masitinib 4.5 mg/kg/day and titrated masitinib 6.0 mg/kg/day parallel groups (FAS population)Unless otherwise stated, this table summarizes data from patients in the masitinib 4.5 mg/kg/day parallel group full analysis dataset (PBO Results from the titrated masitinib dose of 6.0 mg/kg/day parallel group did not show any significant difference between the masitinib and placebo treatment arms for either ADAS-cog or ADCS-ADL; ΔADAS-cog was −0.43 (97.5%CI [(−1.81, 0.95]), 