Baxter International Inc. (NYSE: BAX) and New York-Presbyterian Hospital/Weill Cornell Medical Center today announced results of an 18-month Phase II clinical study of GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the U.S.) for mild-to-moderate Alzheimer's disease. This marked the first announcement of clinical trial results measuring function and cognition in patients who received uninterrupted GAMMAGARD for a period of 18 months.
“The important next step is to fully enroll and complete the ongoing Phase III study of GAMMAGARD, in hope of confirming these Phase II findings and fully understanding GAMMAGARD's potential benefit in Alzheimer's disease.”
The study measured function using the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC) and measured cognition using the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog). After 18 months, patients>
The data are being presented at the American Academy of Neurology (AAN) annual meeting in Toronto by the principal investigator for the trial, Dr. Norman Relkin, and Dr. Diamanto Tsakanikas. Dr. Relkin is the director of the Memory Disorders Program and a behavioral neurologist and neuroscientist at the New York-Presbyterian Hospital/Weill Cornell Medical Center, and associate professor of clinical neurology at Weill Cornell Medical College. Dr. Tsakanikas is a clinical assistant attending neuropsychologist at New York-Presbyterian Hospital/Weill Cornell Medical Center and instructor of neuropsychology in the Department of Neurology & Neuroscience at Weill Cornell Medical College. The study was supported by Baxter, the Citigroup Foundation, and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.
Being presented for the first time, MRI analyses showed that patients who received GAMMAGARD continuously for 18 months experienced decreased mean annual ventricular enlargement rates in their brains (6.7%), compared to control patients who initially received placebo (12.3%,>
"The cognitive and functional outcomes and neuroimaging results from this 18-month Phase II study in participants receiving GAMMAGARD continuously clearly support continued evaluation for Alzheimer's disease in a larger number of patients," said Dr. Paul Aisen, director of the Alzheimer's Disease Cooperative Study. "The important next step is to fully enroll and complete the ongoing Phase III study of GAMMAGARD, in hope of confirming these Phase II findings and fully understanding GAMMAGARD's potential benefit in Alzheimer's disease."