Results from Phase 3 Trial of IVIG for Alzheimer's Disease
New York, NY - Weill Cornell Medical College neurologist Dr. Norman Relkin reported new findings today from the Phase 3 clinical trial of IVIG (intravenous immunoglobulin - a mixture of antibodies derived from the blood of health donors used for over 30 years to control infection and inflammation) in mild to moderate Alzheimer's disease at the Alzheimer's Association International Conference (AAIC) in Boston, Mass. While the primary study outcomes were negative, observations from the subgroup analyses include whether there may be a dose-dependent reduction of beta amyloid in the blood and brain of IVIG-treated Alzheimer's patients who have the ApoE4 genotype.
The Gammaglobulin Alzheimer's Partnership (GAP) Study was a Phase 3, randomized, double-blind, placebo-controlled clinical trial in 390 people with mild to moderate Alzheimer's disease, conducted at 45 centers in the U.S. and Canada. Two different doses of IVIG were tested versus placebo as add-ons to approved Alzheimer's medications. The drug was administered every two weeks for 18 months. Primary study endpoints were changes on two well-established tests of cognition and daily functioning -- the ADAS-Cog and ADCS-ADL.
In a topline announcement in May, the GAP researchers reported negative results on the GAP study's primary outcomes -- the ADAS-Cog and ADCS-ADL. At the same time, preliminary observations were reported on favorable changes on another cognitive test, the Modified Minimental State Examination (3MS) in two subgroups: people with Alzheimer's who carried the APOE-e4 Alzheimer's risk gene, and those who were moderately impaired. The study was not powered to show statistical significance in these pre-planned subgroup analyses. Continue>
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