BAN2401-G000-301 is an 18-month treatment, multicenter, double-blind, placebo-controlled, parallel group for subjects with mild cognitive impairment due to Alzheimer's Disease (AD). A total of 1566 subjects will be randomized across two treatment groups (placebo and BAN2401) at about 1:1 ratio.

The study drug: BAN 2401 is a sterile aqueous solution that will be administered in normal saline as 60 minute intravenous infusions. There will be 3 sub-studies: amyloid PET, cerebrospinal fluid biomarker, and Tau PET. In the amyloid PET sub-study one of the two radioactive tracers will be used: florbetapir or florbetaben. These tracers produce a picture of the amyloid protein deposits inside your brain. In the TAU PET sub-study, an investigational, radioactive tracer called MK-6240 will be used to produce a picture of the tau protein deposits inside your brain. MK-6240 binds to tau protein that creates tangles inside nerve fibers called neurons in patients with AD. At the end of the 18 months, subjects will have the option of joining the open label extension phase. The study is broken up into 3 phases. The pre-randomization phase may last up to 60 days and will consist of a screening period and a baseline period. In this phase subjects will undergo various clinical assessments such as: MMSE (mini-mental state examination), CDR (clinical dementia rating), and GDS (Geriatric depression scale). Imaging and blood sampling will also occur in this phase. Subjects can consent to one, two, or all substudies at any point during the pre-randomization phase. During the randomization phase, subjects will be randomized at visit 3 to either receive the placebo or BAN 2401. They will receive a drug infusion every 2 weeks. Clinical assessments will occur such as: MMSE (mini-mental scale), CDR (clinical dementia rating), and ADAS-COG (Alzheimer's Disease Assessment Scale-Cognitive Subscale). Imaging and blood sampling will also occur during this phase. Subjects who completed the 18-month treatment period will have the option to participate in the extension phase. This phase lasts up to 2-years or until the drug has proven to not work or becomes commercially available. All subjects will receive open label 10mg/kg BAN2401 during the extension phase. If the subject is enrolled in the sub-studies, his/her participation will continue through enrollment in the extension period. Imaging and blood sampling will occur during the extension phase. A follow up visit will take place 3-months after the last dose of the study drug. The study will end when the last visit of the last subject of the extension phase has concluded.