Elan, Wyeth Play by Own Rules in Alzheimer's Trial

Elan(ELN Quote) and Wyeth(WYE Quote) are using a new and unproven endpoint to measure the memory and mental status of patients in phase III trials of their experimental Alzheimer's drug bapineuzumab, say sources familiar with the studies' protocols.

By creating their own test to measure bapineuzumab's efficacy, Elan and Wyeth are seeking an alternative to the so-called ADAS-cog, despite that test's imprimatur as the gold standard measure of cognitive function. The ADAS-cog has been used as the basis for approval for all Alzheimer's disease drugs to date.

Elan has devised a new clinical endpoint, which it calls the Neuropsychological Test Battery, or NTB. The Irish drugmaker has used the NTB in previous studies of its Alzheimer's drugs to demonstrate improvements in the mental status of patients when similar measurements using ADAS-cog showed no benefit. ...