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Investigational immune intervention slows brain shrinkage in Alzheimer's patients
Date:4/13/2010

More details about the study's cognitive testing results will be reported in a later presentation at the AAN meeting by Dr. Diamanto Tsakanikas, who performed cognitive and other testing of the study's participants. Dr. Tsakanikas is a clinical assistant attending neuropsychologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and an instructor of neuropsychology in the Department of Neurology and Neuroscience at Weill Cornell Medical College. While conducting the testing, Dr. Tsakanikas was blinded to whether patients were receiving IGIV or placebo and to the IGIV dose.

When the unblinded study results were later analyzed, her testing indicated that AD patients who received uninterrupted IGIV for 18 months showed significantly less decline in their overall function and thinking abilities than AD patients initially given an inactive placebo. In some cases, IGIV intervention resulted in improvements in certain areas of cognitive functioning. "Functions mediated by the frontal regions of the brain showed the most consistent benefits in IGIV responders," says Dr. Tsakanikas.

The Phase II study involved 24 patients with mild to moderate Alzheimer's disease who were randomly assigned to receive IGIV (16 patients) or saline placebo (eight patients) for six months. Over the following 12 months, the initially placebo-treated group were subsequently received various doses of IGIV while the other 16 patients had uninterrupted IGIV at the initially assigned dose. The study included a comparison of four dosing regimens of IGIV, with doses ranging from 0.2 g/kg every two weeks to 0.8 g/kg every four weeks. "The Phase II study was carried out with the explicit goal of determining whether further testing of IGIV for Alzheimer's was justified," Dr. Relkin points out. "It succeeded in achieving that goal with a relatively small number of subjects. However, we now have to await the results of the larger, pivotal Phase III study to establish the mag
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Contact: John Rodgers
jdr2001@med.cornell.edu
212-821-0560
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
Source:Eurekalert

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