Grifols demonstrates a significant reduction (61%) in the progression of moderate Alzheimer's disease using its AMBAR treatment protocol - Seite 3

Víctor Grífols Roura, Chairman of Grifols, noted "These results unlock a new era in the treatment of Alzheimer's disease and Grifols will continue to explore the potential of plasma proteins and plasma exchange in further studies".  He also stated that "We are very excited with the results, for the progress we have made and for what they may represent for society".

ABOUT AMBAR

AMBAR is an international, multicenter, randomized blinded and placebo controlled, parallel group clinical trial that enrolled mild and moderate Alzheimer patients from 41 Treatment Centers in Europe and the United States. The study was designed to evaluate the efficacy and safety of short-term plasma exchange followed by long-term plasmapheresis with infusion of Human Albumin combined with intravenous immunoglobulin in patients with mild and moderate AD.

AMBAR was designed to evaluate whether the progression of Alzheimer's could be stabilized through plasma exchange, a process that entails periodically extracting plasma and replacing it with a specific albumin solution (Albutein). AMBAR is based on the hypothesis that most of the amyloid-beta protein – one of the proteins accumulated in the brains of Alzheimer's patients – is bound to albumin and circulates in plasma. Extracting this plasma may flush amyloid-beta peptide from the brain into the plasma, thus limiting the disease's impact on the patient's cognitive functions.  Additionally, Albumin may represent a multi-modal approach to the management of the disease due to it's binding capacity, antioxidant, immune modulatory and anti-inflammatory properties.

The AMBAR study included 496 mild and moderate Alzheimer patients, randomized in three treatment groups and one control (placebo) group. The participants were 55-85 years old and the efficacy of treatment was measured by changes in cognition and in daily living activities scores.  An independent contract research organization (CRO), oversaw the trial's clinical monitoring phase and managed the data collection and analysis stages. The trial employed a randomized and double-blind design, meaning that neither patients nor evaluators knew whether subjects were receiving the treatment or the placebo.