A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Conditions

Alzheimer´s Disease

What is the purpose of this trial?

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. 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 subjects and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of subjects. Subjects 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.


Participation Guidelines

Age:
50 Years - 90 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Eisai Pharmaceuticals
Dates:
05/30/2013
Last Updated:
Study HIC#:
1211011120