New Alzheimer’s Drug Shows Promise But Falls Short of Goal

A new drug for the treatment of Alzheimer's disease showed promise for a considerable number of patients in the middle phase of clinical trials, sustaining the decision made by drug makers Elan and Wyeth to start final Phase III testing. The new drug, Bapineuzumab, is based on a new approach to reduce amyloid plaque in the brain believed to cause the disease.

Bapineuzumab did not achieve the overall goals in the Phase II study, however results did show improvement in symptoms over a placebo within a genetic sub-group of Alzheimer's patients known as ApoE4 non-carriers. A large percentage of Alzheimer's patients lack the ApoE4 causing gene. (People who carry the gene that causes their bodies to produce ApoE4 are known to be at increased risk of developing Alzheimer's.) ApoE4 non-carriers showed benefit with Bapineuzumab in several different scoring systems used to measure Alzheimer's disease. Loss of brain volume was also significantly less in these patients. No benefit was seen with the drug in patients with the gene.

"The preliminary analyses of the Phase II study are a continued validation of the amyloid approach to Alzheimer's disease," Elan Chief Executive Kelly Martin said in a statement. Elan and partner Wyeth will continue with plans to conduct more tests on Bapineuzumab. The two companies began four large-scale clinical trials last year with U.S. company, Wyeth funding the studies, which are examining patients with and without the ApoE4 gene.

Over 5 million people in the U.S., as well as 25 million people around the globe, suffer from Alzheimer's disease. About 12.5 percent of baby boomers will become a victim of Alzheimer's disease in their lifetime, which is around 10 million Americans, according to the Alzheimer's Association.

In addition, the Alzheimer's Association March report projects that Medicare spending for Alzheimer's treatment will increase to $38 billion in 2025, when the baby boomers begin to reach the age for nursing home admission. The disease slowly destroys memory and impairs abilities to communicate, make judgments and perform simple daily activities. Unless successful treatments for the disease is developed, costs of medical as well as personal day-to-day care will continue to rise.

Current drugs on the market only offer relief of the symptoms of Alzheimer's. They include Pfizer's Aricept, Shire Ltd.'s Razadyne, Novartis AG's Exelon and Forest Laboratories Inc.'s Namenda.

Other drug makers in the pursuit with Elan and Wyeth to develop drugs that will actually delay or halt Alzheimer's include Eli Lilly & Co. and Myriad Genetics Inc.