On 22 March, Eisai announced the launch of a Phase III clinical trial of BAN2401, an anti-amyloid beta protofibril antibody, in people with early Alzheimer’s disease (AD). BAN2401 is developed under a partnership with Biogen.
The Clarity AD Phase III trial is a placebo-controlled, double-blind, parallel-group and randomised study evaluating BAN2401 in people with mild cognitive impairment due to AD or mild AD dementia with confirmed amyloid accumulation in the brain. Around 1.566 participants will received either BAN2401 (10mg/kg bi-weekly) or placebo. The primary endpoint is the change from baseline in a scale called Clinical Dementia Rating–Sum of Boxes (CDR-SB) at month 18.