18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimers Disease

BAN2401-G000-301 (Study 301) is an 18-month treatment (Core Study), multicenter, double-blind, placebo-controlled, parallel-group study in subjects with EAD (mild cognitive impairment [MCI] due to AD with intermediate likelihood/Prodromal AD or mild AD dementia) with confirmed amyloid pathology indicated by either positive amyloid load confirmed by amyloid PET assessment or CSF assessment of t-tau/A[1-42]. A total of 1566 subjects will be randomized in the Core Study across 2 treatment groups, (placebo and BAN2401 10 mg/kg, biweekly) according to a fixed 1:1 (placebo:BAN2401) schedule. Randomization will occur across 2 clinical subgroups (MCI due to AD/prodromal AD or mild AD dementia), and will be reasonably balanced, such that not less than approximately 50% of total number of subjects will be in the MCI due to AD clinical subgroup. Subjects will be stratified according to clinical subgroup; presence or absence of ongoing approved AD treatment (eg, acetylcholinesterase inhibitors [acetylcholinesterase inhibitors], memantine, or both); ApoE4 status (ie, ApoE4 carriers or non-carriers); and geographical region. Treatment in the Core Study will be for 18 months. At the end of the Core Study, subjects will have the option of entering the Extension Phase. An Extension Phase will be available for subjects who complete the full 18 months of treatment in the Core Study and will continue for up to 2 years, or until commercial availability of BAN2401, or until a positive risk-benefit assessment in this indication is not demonstrated.