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Posted: May 06, 2008

Success Reported in Small Trial of New Alzheimer's Drug

Alzheimer’s experts are tracking of early success in a small trial of a new drug intended to treat patients with mild-to-moderate stage Alzheimer’s disease.
The success was reported by drug maker Baxter International, which said the early test results of its intravenous plasma-based treatment Gammagard were promising.
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"This was the first placebo-controlled clinical trial of Gammagard for Alzheimer's disease, and the results are clearly promising," Dr. Norman Relkin, a New York City neurologist and international authority on Alzheimer’s disease, said in a statement. Relkin presented the results at an American Academy of Neurology meeting in Chicago.
Baxter announced that Gammagard met the primary goals of a six-month trial of 24 patients by proving to be more effective than a placebo at improving the measures of cognitive functioning and patients’ general recognition of change around them. It also met secondary goals of measuring the blood and spinal-fluid levels of beta-amyloid and anti-amyloid antibodies in test participants, the company said.
The Deerfield, Illinois-based company added, however, that the trial was too small to draw statistical conclusions of any significance.
Gammagard, an intravenous immunoglobulin derived from human plasma, is currently approved to treat immune system disorders.
Baxter and The Alzheimer's Disease Cooperative Study (ADCS) group said they would pursue a US-based multi-center Phase III study evaluating the role of Gammagard. The study design is undergoing review with the Food and Drug Administration with the intention of starting to recruit patients later this year. The trial is expected to include approximately 35 leading academic centers in the United States that are members of ADCS.
Phase III is typically the final stage of human testing before a company seeks approval to sell the medicine for that use.

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