|
The next step in Curaxis’ clinical development plan for our Alzheimer’s treatment is a Phase IIb study in approximately 200-250 women. The purpose of this study is to confirm the efficacy results we achieved in our earlier clinical trial in women and provide a foundation for determining the size and duration of Phase III studies of VP 4896 in women with mild to moderate Alzheimer’s disease.
We anticipate that the study will be a 12-month, double-blind, placebo-controlled study consisting of 1 active arm and the placebo arm, with a 60/40 split between the active arm and the placebo arm. Assuming the study commenced in the second quarter of 2010, and that enrollment was completed by the end of 2010, the Company would anticipate that the results of the study could be available during the first quarter of 2012.
|