June 18, 2008

Promising Alzheimer’s Drug Approved for Late-Stage Trials

By Mary Brophy Marcus

An experimental drug for Alzheimer's disease patients showed promise in Phase II clinical trials and is moving into final-stage trials, Wyeth and Elan, the makers of bapineuzumab, announced Tuesday.

Bapineuzumab is designed to fight beta amyloid, a toxic protein that clumps together in the brains of Alzheimer's patients.

In the early studies, conducted around the USA, 240 people with early- to moderate-stage Alzheimer's disease were either assigned bapineuzumab or a placebo. Researchers reported that non-carriers of a gene considered to be a risk factor for Alzheimer's disease, called ApoE4, showed "clinically meaningful benefits" in a battery of tests used to track the progression of Alzheimer's disease. The tests measured functions including recall, language and the ability to manipulate objects.

MRIs also revealed that the non-ApoE4 carriers showed less loss of brain volume over time compared with patients who received a placebo.

The experimental drug has promise, but it will be several years or more -- if all goes well in the final clinical trials and it receives government approval -- before it goes to market, says one of the study's investigators, Anton Porsteinsson, director of Alzheimer's Disease Care at the University of Rochester Medical Center.

Adverse side effects were reported in both placebo and drug groups, Porsteinsson says. However, ankle swelling, which was reported in the drug group, was more common in ApoE4 carriers and those taking higher doses of the drug.

Wyeth and Elan's Phase III studies kicked off globally last December and are still being organized to include 4,100 patients worldwide, says Wyeth spokesman Michael Lampe.

Several other drug companies are working on similar approaches, says Howard Fillit, executive director of the Alzheimer's Drug Discovery Foundation and a clinical professor of geriatrics and medicine and professor of neurobiology at the Mount Sinai School of Medicine in New York.

Most scientists in the field view the amyloid strategy as the leading strategy right now, Fillit says. "It's very exciting. I think that we should all have hope. We don't know how the Phase III trials are going to turn out, but I think for all of us who are terrified of getting Alzheimer's or for geriatricians, like me, who treat this disease, this tragic nightmare, these studies are giving us great hope that within five years, I would say, we are going to have a disease-modifying drug on the market."

Gary Kennedy, director of geriatric psychiatry at Montefiore Medical Center in New York, says caution, but not skepticism, is advised. "There's an awful lot of excitement about the science. We've got a lesion in the brain and know the mechanism by which it works. We have lots of weapons to use in this battle, but they may all be directed at the wrong target." (c) Copyright 2008 USA TODAY, a division of Gannett Co. Inc. <>