Study design
DISEASE
Study AB09004 was an international, double-blind, multicenter, phase 3, randomized, placebo-controlled trial over a 24-week treatment period. Following the aforementioned protocol amendments, two prospectively declared parallel groups, distinct in matters of statistical analysis and control arm (i.e., effectively run as separate studies), were assessed.Patients were centrally randomized using an interactive web-response system according to a computer-generated assignment schedule and minimization method with covariates of ADAS-cog total score, ADCS-ADL total score, severity of baseline disease (Mini-Mental State Examination (MMSE) 21–25 versus 12–20), and age at baseline (50–79 versus ≥80). Patients and study staff were masked to treatment assignment for the study duration.