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Secondary endpoint results suggest that levels of antibodies againstbeta-amyloid were observed to have increased in the blood and cerebrospinalfluid of patients treated with GAMMAGARD S/D and GAMMAGARD LIQUID, while thelevels of beta-amyloid increased in the blood. Beta-amyloid is a substancethought to contribute to the degeneration of the brain in Alzheimer's disease.Clearing this substance from the central nervous system, therefore ishypothesized to help remove or reduce the building blocks of Alzheimer's.
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The primary and secondary endpoint data were reported by the leadresearcher for the trial, Dr. Norman Relkin, director of the Memory DisordersProgram and behavioral neurologist and neuroscientist at NewYork-Presbyterian/Weill Cornell Medical Center, and associate professor ofclinical neurology at Weill Cornell Medical College in New York City.
"This was the first placebo-controlled clinical trial of GAMMAGARD forAlzheimer's disease and the results are clearly promising," Dr. Relkincommented.
Baxter supported the study and provided GAMMAGARD LIQUID and GAMMAGARD S/Dfor the trial. GAMMAGARD S/D and GAMMAGARD LIQUID, marketed as KIOVIG in theEuropean Union, contain a broad spectrum of immunoglobulins (antibodies) andare indicated as an immunoglobulin replacement therapy that boosts the immunesystem in patients with primary immunodeficiency disorders. The precisemechanisms of GAMMAGARD S/D and GAMMAGARD LIQUID's effects in Alzheimer'sdisease are not known.
"These study results reflect Baxter's support of innovative science andcommitment to meeting a critical, unmet medical need," said Hartmut J.Ehrlich, MD, vice president of global research and development for Baxter'sBioScience business. "While results of Baxter's mid-stage development work inAlzheimer's disease treatment are promising, further investigation in a largerPhase III study is required."
Phase II Study Design
In the double-blind, placebo-controlled Phase II study, 24 patients in theUnited States with mild-to-moderate Alzheimer's disease, who were maintainedon standard treatment therapy, were randomly assigned to receive GAMMAGARDLIQUID (eight patients), GAMMAGARD S/D (eight patients) or saline placebo(eight patients) for six months. The study included a comparison of fourdosing regimens of GAMMAGARD, with doses ranging from 0.2 g/kg every two weeksto 0.8 g/kg every month. The safety and tolerability of the treatment andclinical outcomes of 24 patients were assessed at the beginning of the studyand after three and six months. The study is an ongoing, open-label studyextended to 18 months to examine the long-term effects of the treatment.
Cognitive, behavioral and functional measures were collected at baseline,three m
