The Phase III clinical program for bapineuzumab is intended to provide safety and efficacy data to support the filing and approval.
The Phase III study includes four randomized, double-blind, placebo-controlled studies in approximately 4,000 total patients with mild to moderate Alzheimer’s disease. More than 350 sites worldwide are expected to participate in the program. Patients are planned to be distributed equally between NA and the rest of the world (ROW). The NA studies now are under way. The ROW studies are expected to begin enrolling patients in early 2008.
Each of the four studies will have co-primary efficacy endpoints, one cognitive and one functional, and patients are planned to participate for 18 months and will be evaluated using several methods, including neuropsychiatric scales and imaging and biomarker analysis.