Updated on 7 August 2012
Four placebo-controlled phase III studies comprised the bapineuzumab clinical development program. Janssen led the two completed 18-month, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients who are ApoE4 carriers (Study 302) and ApoE4 non-carriers (Study 301).
The two co-primary clinical endpoints changed in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), which is a validated measure of cognition, and also in the the Disability Assessment for Dementia (DAD), a validated instrument to measure function.
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