Drugmaker Elan and US partner Wyeth announced Thursday they have stopped part of a Phase III clinical trial for their Alzheimer’s treatment bapineuzumab because patients are suffering from an increased risk of brain inflammation from water retention.

 

To be more specific, the companies will halt that part of the trial using the drug at its highest dose for the treatment of Alzheimer’s disease (2.00 mg/kg), after there were signaled cases of vasogenic edema. The condition was detected early using MRI scans on the brains of patients who were not displaying symptoms associated with water-inflamed brains.

 

“Our review of the safety data and the feedback from the Safety Monitoring Committee made it clear that continued development of the highest dose was not advisable. The decision to remove the highest dose from development reduces risk to patients, and it also helps to reduce risk to the overall development effort,” Elan President Carlos Paya said. He also acknowledged the fact that cases of Alzheimer’s disease have increased recently and the need for a treatment able to stop it is critical.

 

The companies didn’t disclose how many patients were affected by vasogenic edema. Two other phase III studies will continue and patients given the highest dose of the drug will switch to a lower dose. The studies involve patients carrying the ApoE4 gene, known to have an increased risk for brain swelling.