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Revised rules aim to speed new Alzheimer's drugs

By Marilynn Marchione
AP Medical Writer / July 12, 2011

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The government is making it easier to test new Alzheimer's drugs, hoping to speed progress toward new treatments for the mind-robbing disease.

One of every eight people 65 or older has Alzheimer's, the most common form of dementia. Current drugs only ease symptoms temporarily and don't slow its advance.

Many drugs have flopped in late-stage testing in recent years, including some that seemed to clear harmful plaque from addled brains.

Last year, the Food and Drug Administration put restrictions on who could be in experiments targeting this plaque. They agency said participants had to drop out if they developed signs of bleeding in the brain.

A panel of industry, nonprofit and academic researchers thought that would choke off promising research. They gathered evidence that such bleeding and other abnormalities seen on brain scans were fairly common and might even be a sign that a drug is working as intended.

That would mean it doesn't necessarily doom a treatment, said Dr. Reisa Sperling, director of the Center for Alzheimer Research and Treatment at Brigham and Women's and Massachusetts General Hospitals. "It's not clear yet whether these are a sign of damage, but they may not be as concerning as we initially thought."

The FDA was persuaded, and adopted the panel's findings, which are being published online Tuesday in the journal Alzheimer's & Dementia.

The relaxed rules are a boon for companies like Pfizer Inc. and Johnson & Johnson subsidiary Janssen Alzheimer Immunotherapy, which are testing an experimental drug called bapineuzumab (bap-ih-NUZE-uh-mab) in thousands of patients now. Eli Lilly & Co. also has an Alzheimer's drug in late-stage tests. Those companies took part in the panel that came up with the new rules.

They will be discussed next week at an international Alzheimer's Association conference in Paris.

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Online:

National Institute on Aging: http://www.nia.nih.gov/Alzheimers

Alzheimer's Association: http://www.alz.org

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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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