WILMINGTON, Del., Sept. 15 /PRNewswire-FirstCall/ --
-- Results inconclusive, as primary outcome measure not statistically
significant for either donepezil or AZD3480; results impacted by
improvement in placebo group
-- Improvements shown on secondary outcome measures ADCS-CGIC and MMSE
-- Overall safety and tolerability profile comparable to placebo, with
fewer GI-related AEs than donepezil
-- Next steps include further analysis of full dataset and planned
discussions with leading medical experts
AstraZeneca (NYSE: AZN) and Targacept, Inc. today announced that results from the Phase IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in mild to moderate Alzheimer's disease were inconclusive.
In the 12-week placebo-controlled study, known as the Sirocco trial, neither the active comparator donepezil nor AZD3480 met the trial's criteria for statistical significance on the primary outcome measure, ADAS-Cog (Alzheimer's Disease Assessment Scale -- Cognition Subscale.) Both results were impacted by an improvement in the placebo group.
At two of the three doses tested, AZD3480 showed an improvement on the
secondary outcome measures ADCS-CGIC (Alzheimer's Disease Cooperative Study
-- Clinical Global Impression of Change, a 7-point scale), a widely
accepted measure of clinician assessment of change in patients' behavior
and ability to function, and MMSE (Mini Mental State Examination, a
30-point scale), a quantitative cognition scale commonly used by
neurologists in a clinical setting. Of the three AZD3480 doses, the middle
dose performed best on both measures (0.5 point improvement, ADCS-CGIC and
0.9 point improvement, MMSE). Donepezil also sh
Copyright©2008 PR Newswire.
All rights reserved