TUESDAY, July 17 (HealthDay News) -- Alzheimer's disease (AD) symptoms stabilize among patients treated with intravenous immunoglobulin (IVIG) for 36 months, according to a small study presented at the annual Alzheimer's Association International Conference, held from July 14 to 19 in Vancouver, Canada.
Norman Relkin, M.D., Ph.D., from Weill Cornell Medical College in New York City, and colleagues conducted a 12-month open-label extension for participants with mild-to-moderate AD who had participated in a Phase 2 double-blind placebo-controlled study of IVIG. Following six months of placebo-controlled treatment, all subjects received IVIG for a 12-month open-label extension. Those from the Phase 2 study wishing to continue treatment received IVIG (0.4 g/kg every two weeks) beginning at post-enrollment month 18, with subjects returning for clinical evaluations at six-month intervals.
The researchers found that, of the originally enrolled subjects, 16 received treatment through month 36 (five originally treated with placebo and 11 given IVIG at various doses from time of randomization). The best outcomes were seen in subjects who were treated with IVIG 0.4 g/kg every two weeks for the full 36 months. They had no decline in standard measures of cognition, memory, daily functioning, and mood at the three-year end point, whereas subjects treated initially with placebo experienced less rapid decline while receiving a uniform dose of IVIG.
"This is the first study to report long-term stabilization of Alzheimer's symptoms with IVIG," Relkin said in a statement. "While the small number of participants may limit the reliability of our findings, we are very enthusiastic about the results. A Phase 3 trial is in progress and, in less than one year, we'll have more definitive data on the efficacy of 18 months of IVIG treatment."
The study was funded in part by Baxter BioScience, which manufactures Gammagard, the intravenous immunoglobulin used in the study.
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