The Phase 3 Clarity AD study involves subjects in the US, Canada, Europe and Asia with Mild Cognitive Impairment due to Alzheimer’s disease or subjects with mild Alzheimer’s disease and their relatives. Subjects with these diagnoses may be eligible for the study, if they have a Mini Mental State Examination (MMSE) score greater than or equal to 22 and less than or equal to 30, as well as positive biomarkers for brain amyloid. Study details in addition to inclusion and exclusion criteria can be found at ClinicalTrials.Gov (https://clinicaltrials.gov/ct2/show/NCT03887455?term=BAN2401&rank=1). The participants in the study are randomized to either BAN2401 or placebo dosed over an 18-month period and administered as an infusion once every two weeks.
The sponsor is Eisai Inc. in collaboration with Biogen.
Hans Basun, Professor, MD
Senior Director, Clinical Development, BioArctic