CHICAGO – Continuous intravenous infusions of immunoglobulin for 9 months stabilized cognition and function for Alzheimer's patients enrolled in a small placebo-controlled trial.
The 18-month-long phase II study included 24 patients with mild to moderate Alzheimer's. For the first 6 months, they were randomized either to placebo or to one of four intravenous immunoglobulin (IVIG) doses.
For the remaining 12 months, all the participants were switched to IVIG, but raters were still blinded to the dosing, said Dr. Norman Relkin, who presented the study's 9-month results at the International Conference on Alzheimer's Disease.
Patients who had received IVIG continuously for 9 months showed significantly better scores on measures of cognition and activities of daily living than did those taking placebo.
When the IVIG arms were analyzed by dose, 0.4 g/kg of body weight every 2 weeks provided the best results in global functioning, cognition, and activities of daily living, Dr. Relkin said at the meeting, which was sponsored by the Alzheimer's Association.
Planning for a larger, phase III trial is underway; it is to be conducted at 35 academic centers in the United States.
Dr. Relkin of Cornell University, New York, coauthored another IVIG study published earlier this year that found that improvements in Alzheimer's patients treated with IVIG lasted only as long as the treatment continued.
The trial of continuous IVIG treatment was cosponsored by the National Institutes of Health and Baxter International Inc.
Dr. Relkin said he received grants and research support from Baxter.