The current Baxter studies of immunoglobulin in mild to moderate Alzheimer's disease would be discontinued, Baxter officials said.
The Gammaglobulin Alzheimer's Partnership study was conducted by Baxter in collaboration with the Alzheimer's Disease Cooperative Study, a clinical trial consortium supported by the National Institute on Aging, part of the National Institutes of Health.
The randomized, double-blind, placebo-controlled, multicenter trial found after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's immunoglobulin treatment at either the 400 milligrams/kg or the 200 mg/kg dose did not demonstrate a statistically significant difference in the rate of cognitive decline as compared to placebo.
"The study missed its primary endpoints, however we remain interested by the pre-specified sub-group analyses, particularly among patients with moderate disease and those who carry a genetic risk factor for Alzheimer's disease, two patient groups that are in great need of advances in care," Ludwig Hantson, president of Baxter's BioScience business, said in a statement.
"A detailed analysis of the results from the Gammaglobulin Alzheimer's Partnership study continues, and we look forward to a greater understanding of the full data set."
Based on these results, Baxter officials said they would reconsider its current approach for its Alzheimer's program and will determine next steps after full data analyses.
Additional analyses from the study, including imaging, will be made available later this year as part of a full presentation of the study at the Alzheimer's Association International Conference, July 13-18, in Boston.
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