Elan drops top Alzheimer's drug dosage in trial

Researchers for Elan and Wyeth have decided to drop the highest dose of their Alzheimer's drug bapineuzumab from two late-stage studies after determining that patients in the study were at risk of swelling of the brain. Patients taking the higher dose are being switched to a lower dose of the drug.

These particular trials recruited patients who don't have the ApoE4 gene, which increases risk of brain swelling. TheStreet's Adam Feuerstein notes that the move to drop the dose indicates the risk of brain swelling is higher than either company anticipated. Two other late stage trials that are testing a lower dose of the drug are not affected.

"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," said Elan President Carlos Playa in a statement. "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."

Researchers have been dogged by disagreement over the implications of a mid-stage study. Researchers concluded that the therapy improved cognition in patients without the critical gene, but some said the results were unconvincing.

The companies didn't disclose how many patients could have been affected.

- here's Elan's statement [1]
- read the report [2] from TheStreet

Related Articles:
Elan triggers strategic review, spurring merger buzz [3]
Alzheimer's drug results boost Elan, Wyeth [4]
Wyeth, Elan advance Phase III Alzheimer's trial [5]