MIAMI BEACH (Reuters Health) - Intravenous immunoglobulin (IVIg) shows promise for arresting -- and perhaps even reversing -- the cognitive decline of Alzheimer’s disease, a preliminary study suggests.
“Our very small study suggests that this already approved antibody product may be useful for treating Alzheimer’s disease,” Dr. Norman R. Relkin, at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York. Cognitive functioning improved in six of seven Alzheimer’s disease patients given IVIg for 6 months, he reported at the annual meeting of the American Academy of Neurology.
IVIg contains a relatively high level of anti-amyloid beta antibodies, Dr. Relkin told Reuters Health.
In a phase I trial, the researchers administered IVIg to seven women and one man diagnosed with mild-to-moderate Alzheimer’s disease. The patients, whose mean age was 74 years, had a mean Mini-Mental Status Examination (MMSE) score of 23.5.
The patients were randomized to receive one of four dosing regimens: 0.4 g/kg every 2 weeks, 0.4 g/kg every week, 1.0 g/kg every 2 weeks, or 2.0 g/kg every month. Anti-amyloid antibody levels increased significantly in plasma after each IVIg infusion in a dose-dependent fashion. Also, anti-amyloid antibody levels rose incrementally with successive treatments, the study showed.
Of the seven patients who completed 6 months of treatment, none had decreased cognitive function and six had improved cognitive function, Dr. Relkin said. “In 6 months, one would expect a 1.5-point decline in MMSE scores. Our patients showed a 3-point increase.”
The participants experienced only minor and infrequent side effects, such as chills following the infusion.
The study was funded by a grant from Baxter BioScience, which manufactures IVIg as Gammagard. A separate study in Germany, in which five patients were given IVIg, showed similar results, he said.
Together, the two small studies “give us strong encouragement,” Dr. Relkin said. But, he stressed, it is too soon to start treating Alzheimer’s disease patients with IVIg.
If IVIg shows good results in phase II and III studies, Dr. Relkin said he hopes to purify the anti-amyloid antibody from the blood product and make a synthetic formulation to treat patients.
“Because IVIg is derived from pooled blood, it’s in limited supply. The synthesized antibody product would be cheaper and in more ample supply,” he said.
MeSH Headings:Amyloid: Clinical Trials: Congresses: Health Care Economics and Organizations: Environment and Public Health: Epidemiologic Methods: Evaluation Studies: Health: Health Occupations: Health Services Administration: Medicine: Investigative Techniques: Organizations: Population Characteristics: Preventive Medicine: Public Health: Quality of Health Care: Specialties, Medical: Epidemiologic Study Characteristics: Clinical Trials, Phase I: Health Care Quality, Access, and Evaluation: Health Care Evaluation Mechanisms: Amyloid Neuropathies: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Biological Sciences: Health CareCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.