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AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimer's Disease
Date:9/15/2008


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
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SOURCE AstraZeneca
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