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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

tcome in Alzheimer's disease clinical trials. The ADCS-CGIC is used in Alzheimer's trials to assess clinically relevant overall changes in Alzheimer's disease patients determined by patient and caregiver interviews.

Patients treated with GAMMAGARD S/D and GAMMAGARD LIQUID had fewer behavior-related adverse events during the six-month trial and had a more favorable behavioral outcome as measured by the Neuropsychiatric Inventory, a scale used to measure behavioral problems in Alzheimer's patients. The average change in ADAS-Cog score -- a common cognitive testing measure -- at six months of treatment was numerically improved in patients treated with GAMMAGARD S/D and GAMMAGARD LIQUID than placebo (-0.38 versus +2.61), although this difference did not reach statistical significance in the relatively small number of patients studied.

Levels of Beta-Amyloid (Secondary Endpoints)

Dr. Relkin also reported observations that levels of antibodies against beta-amyloid increased in the cerebrospinal fluid and blood of patients treated with GAMMAGARD S/D and GAMMAGARD LIQUID, while the levels of beta-amyloid in the blood increased. The antibody and beta-amyloid levels were assessed using ELISA immunosorbant assay, a method used to detect antibodies, and observations were analyzed using parametric statistical analysis.

Tolerability

The study also met its endpoint in assessing the tolerability of GAMMAGARD S/D and GAMMAGARD LIQUID in Alzheimer's patients. The only treatment-related adverse events that occurred at a greater frequency with GAMMAGARD S/D and GAMMAGARD LIQUID treatment as compared to placebo were rash and a transient drop in blood count (in most cases, hemoglobin (Hgb) levels returned to within 1 Hgb unit of baseline within three to six months).

Brain Metabolism (Additional, Observational Finding)

Dr. Lisa Mosconi, assistant professor of psychiatry at New York University Medical Center, worked with the New York-Presbyt
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SOURCE Baxter International Inc.
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