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Study Results of GAMMAGARD S/D and GAMMAGARD LIQUID in Patients with Mild-to-Moderate Alzheimer's Disease Announced
Date:4/17/2008

8 months to examine the long-term effects of the treatment.

Cognitive, behavioral and functional measures were collected at baseline, three months and six months of treatment. The primary endpoints of the Phase II trial were cognitive function (as measured by the ADAS-cog) and global impression of change (as assessed by the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) change rating). The secondary endpoints measured changes in beta-amyloid and anti-amyloid antibody levels in blood and cerebrospinal fluid. Safety and tolerability of GAMMAGARD S/D and GAMMAGARD LIQUID treatment in Alzheimer's patients were also assessed relative to placebo.

Phase II Study Results

In August 2007, Baxter and New York-Presbyterian/Weill Cornell announced preliminary Phase II results based on six-month data, indicating the study provided encouragement to carry out a Phase III trial. The criteria for going forward with a Phase III trial were favorable outcomes in GAMMAGARD S/D and GAMMAGARD LIQUID-treated patients relative to those given placebo. The final results of the study re-affirm the decision of Baxter and the ADCS to pursue a multi-center, Phase III study evaluating the role of GAMMAGARD LIQUID for the treatment of patients with mild-to-moderate Alzheimer's disease. The decision was based on results of two completed, open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

The Phase II study follows an earlier Phase I study in eight patients carried out at New York-Presbyterian/Weill Cornell that was published in the journal Neurobiology of Aging in February 2008.

Cognitive Function and Global Impression of Change Findings (Primary Endpoints)

After six months, the group of patients treated with GAMMAGARD S/D and GAMMAGARD LIQUID averaged 1.52 points higher than placebo-treated patients (+0.27 versus -1.25) on the ADCS-CGIC score, a commonly used measure of ou
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SOURCE Baxter International Inc.
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