Is Brain Swelling Common To Alzheimer’s Drugs?

Is Brain Swelling Common To Alzheimer’s Drugs?

July 19th, 2011 // 12:47 pm @

Three patients who were treated with an Alzheimer’s med being developed by Bristol-Myers Squibb wound up with a brain-swelling condition known as vasogenic edema, but the side effect may be common in Alzheimer’s patients, according to researchers who were speaking at the Alzheimer’s International Conference in Paris.

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Rather than signal a problem, vasogenic edema may be a sign that drugs are clearing a protein tied to Alzheimer’s from the brain, Reuters writes. This could, by the way, provide a lift to Pfizer and Johnson & Johnson, which are developing a drug called bapineuzumab that yielded a dozen cases of vasogenic edema in a 2008 Phase II study .

Previous cases of swelling were seen in drugs that use antibodies to remove clumps of the beta amyloid protein that is from the brain, but the Bristol-Myers med, labeled BMS-708163, is a gamma-secretase inhibitor that targets the disease with a different mechanism, Reuters notes.

“No one had thought this was likely in a trial of a gamma-secretase inhibitor,” Reisa Sperling of Harvard Medical School and Massachusetts General Hospital told the Alzheimer’s gathering. She added that the presence of the effect in different classes of drugs showed vasogenic edema may be more common than previously thought. The side effect may be related to clearing amyloid from the brain or may be a side effect that occurs spontaneously in Alzheimer’s patients.

Although vasogenic edema was visible on brain scans, none of the patients in the Bristol-Myers study had clinical symptoms and all three had a mutation in the APOE4 gene that raises the risk of Alzheimer’s disease. One patient had signs of brain swelling at the beginning of the study, and Sperling says brain scans showed that patient’s condition worsened during the six-month study. “Whether the treatment increased it, I don’t know,” she tells Reuters.

Last year, Eli Lilly halted two studies of its gamma-secretase drug, called semagacestat, after worsening dementia symptoms in late-stage clinical trials. And in January, the drugmaker said one patient in an ongoing trial of its antibody drug solanezumab temporarily developed vasogenic edema, although it was not clear whether the patient was taking the Lilly drug or a placebo, Reuters writes.

Concerns over the bapineuzumab study in 2008 prompted the U.S. Food and Drug Administration to issue stricter safety guidelines for clinical trials of drugs that alter amyloid in the brain. But last week, a group of academic and industry experts has convinced the FDA to ease safety restrictions on clinical trials for Alzheimer’s drugs .

Source: Pharmalot


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