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Large Scale Trials of Alzheimer's “Vaccine” at Hundreds of Centers in US, Canada, 20 Other Countries

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www.ProHealth.com • January 8, 2009


Therapy involves periodic infusion of plaque-targeting antibodies

Researchers at hundreds of locations across the US & Canada and in 20 other countries are conducting/recruiting for a constellation of Phase III (large scale) trials of the drug bapineuzumab.

The drug is defined as “a humanized monoclonal antibody,” which is designed to bind to and clear beta amyloid peptide (Alzheimer’s brain plaques), and “to provide antibodies to beta amyloid directly to the patient.” The goal – to determine the drug’s ability to intervene in the progression of Alzheimer’s disease in patients who are and are not Apolipoprotein E4 carriers.

Bapineuzumab is delivered in a series of infusions. This approach is called “passive immunization,” since the body is receiving the antibodies via the drug, rather then generating the antibodies itself, according to Dr. Douglas Scharre, MD, a neurologist at Ohio State University Medical Center who is leading OSU’s involvement in the research. To view a brief video on the trial released recently by OSU, click here.

“The early results from animal studies have been very promising, and we are now looking to see if we achieve the same outcomes with our patients,” says Dr. Scharre. “The first goal is to find a way to prevent the progression of the disease. If we can’t prevent it, studies have shown that delaying the onset for five years would result in a 50 percent reduction in the number of cases.”

The Phase III trials include:

• “Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease” (Clinicaltrials.gov ID NCT00575055) involving centers across the US and Canada - is a “double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD who are Apolipoprotein E4 carriers… Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.”

• “Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease” (Clinicaltrials.gov ID NCT00574132) – also involving US and Canadian centers, is for patients who are not Apolipoprotein E4 carriers.

• “Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients” (Clinicaltrials.gov ID NCT00676143) – involving centers in 20 countries outside the US, for patients who are Apolipoprotein E4 carriers

• “Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients” (Clinicaltrials.gov ID NCT00667810) – involving centers in 20 countries outside the US, for patients who are not Apolipoprotein E4 carriers.

For more information and to review the listings of trial centers, visit the ClinicalTrials.gov listings for these studies. The studies are sponsored by Elan Pharmaceuticals in the US/Canada and Wyeth elsewhere.

Sources: Jan 5, 2009 news release, Ohio State University College of Medicine; ClinicalTrials.gov; Alzheimer Research Forum.




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