Baxter announced today that Gammagard did not provide any cognitive or functional improvement in 390 patients with mild to moderate Alzheimer’s disease. The patients who were enrolled in the Phase III trial received the drug through infusions over an 18 month period.
This outcome isn’t surprising for a number of reasons, including Baxter’s decision to proceed with an expensive Phase III trial based on modest improvement in a total of 4, count them: 4 patients in an earlier trial.
Gammagard is now added to the list of other clinical trial blowups that relied almost exclusively on the amyloid hypothesis. Turning the Alzheimer’s research community towards other avenues such as hyperphosphorylated tau may pick up speed now with amyloid clearance drugs approaching 20 clinical trial fails.
Readers can download a free report on early detection testing for Alzheimer’s disease that also includes a snapshot of other Alzheimer’s drug candidates.