Biogen Inc (BIIB)

[XenaLives]

We are talking P2 here folks.

Brief Summary:
This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of BAN2401 to determine clinical efficacy and to explore the dose response of BAN2401 using a composite clinical score (ADCOMS). BAN2401-G000-201 is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. In the event of early success in the Core Study at any interim analysis (IA) or at the Bayesian analysis at 12 months of treatment, an open label extension (OLE) Phase will be implemented to allow for up to 60 months (5 years) of additional treatment. The OLE will not be conducted if early success is not achieved at any IA or at the Bayesian analysis at 12 months of treatment.

oops they had to stretch to 18 months to get any data that could be mined. Complete FAIL dressed up as a success.

https://clinicaltrials.gov/ct2/show/NCT01767311