Study overview
AD, MCI
DISEASE
This randomized, parallel-group study consisted of a 78-week double-blind, placebo-controlled phase and a subsequent dose-blind LTE phase. Enrolled participants were randomized (1:1:2:2) to one of four treatment arms: (1) low-dose gosuranemab (participants in this group were subsequently randomized 1:1 to receive either 125 mg gosuranemab q4w or 375 mg gosuranemab q12w), (2) intermediate-dose gosuranemab (600 mg q4w), (3) high-dose gosuranemab (2,000 mg q4w) or (4) placebo (0.9% NaCl q4w). Randomization was conducted by interactive response technology (IRT); the IRT vendor generated the randomization sequence. Randomization was stratified by region, disease stage (MCI or mild AD), baseline AD medication use and tau PET and/or CSF substudy enrollment (see the ‘