Immunoglobulin (Baxter) fails Phase III study for treatment of Alzheimers disease

Baxter International Inc. has announced that its Phase III clinical study of immunoglobulin (IG) did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. The Gammaglobulin Alzheimer's Partnership (GAP) study was conducted by Baxter in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium supported by the United States National Institute on Aging in the National Institutes of Health.

Topline analyses from the randomized, double-blind, placebo-controlled, multi-center trial found that after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's IG treatment at either the 400 mg/kg or the 200 mg/kg dose did not demonstrate a statistically significant difference in the rate of cognitive decline as compared to placebo (mean 7.4 in the 400 mg/kg group, 8.9 in the 200 mg/kg group, and 8.4 in the placebo group). Results also did not indicate a statistically significant change in functional ability as compared to placebo (mean -11.4 in the 400 mg/kg group, -12.4 in the 200 mg/kg group, and -11.4 in the placebo group.

.The current Baxter studies of IG in mild to moderate Alzheimer's disease will be discontinued.