The Journal of the Alzheimer's and Dementia Association, the peer-reviewed scientific journal, today has published Results from the Alzheimer's disease Management by Albumin Replacement (AMBAR) study (NCT01561053) published in Alzheimer's & Dementia showed treatment with albumin via plasmapheresis may delay the cognitive and functional decline in Alzheimer disease (AD). This clinical trial was designed to assess the effects of plasma protein replacement therapy in participants with either mild or moderate stages of AD. The results reveal a positive impact in reducing the progression of AD symptoms in participants treated over a 14-month period compared with untreated individuals.
The findings of the AMBAR clinical trial demonstrate a delay in the cognitive and functional decline in AD participants when their plasma is replaced with albumin solution (Albutein; Grifol, Los Angeles, CA) and immunoglobulin (plasma-derived proteins) (Flebogamma; Grifol, Los Angeles, CA) following the process of plasma extraction, using the plasmapheresis technique.
The AMBAR study is an international multicenter randomized double-blind placebo-controlled, with parallel assignment clinical trial that enrolled participants with mild and moderate AD from 41 treatment centers. The study was designed to evaluate the efficacy and safety of short-term plasma exchange followed by long-term plasmapheresis with infusion of albumin combined with intravenous immunoglobulin. The study was designed to evaluate whether the progression of AD could be stabilized through therapeutic plasma exchange, a process that entails periodically extracting plasma and infusing albumin solution with or without intravenous immunoglobulin.
According to Dr. Antonio Páez, Grifols' medical director of the Ambar clinical program and one of the main authors of the article, "These findings are very encouraging. Their publication in one of the most influential journals in the field underscores the relevance of Grifols' research over the last 15 years and its innovative new approach in the fight against AD."
According to Eduardo Herrero, president of the Bioscience division industrial group of Grifols, "This publication leads the way on the future development of plasma protein replacement therapies. At Grifols, we continue our efforts to expand their possibilities so that thousands of patients can benefit."
Zachary S. Gillis, BS, and Michael S. Cartwright, MD, MS
Monika Krzesniak-Swinarska, MD
Farhat Husain, MD; Divya Singhal, MD; and Sergio Ramirez Salazar, MD