September 15, 2008 – AstraZeneca (NYSE:AZN) and Targacept, Inc. 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 showed an improvement on ADCS-CGIC (0.2 point improvement) and the MMSE (1.0 point improvement). Neither donepezil nor AZD3480 showed improvement in any domain of the Cognitive Drug Research computerized test battery in the pooled dataset of all subjects... AstraZeneca's Press Release - Targacept's Press Release -
