Clinical Trials

Grifols' commitment to Alzheimer's disease research began more than 15 years ago, when the company decided to explore the potential of plasma therapies to treat this devastating neurodegenerative disease. Preclinical trials began in 2004, with two pilot preclinical studies and a phase II clinical trial before starting the AMBAR® (Alzheimer Management by Albumin Replacement) study.

The AMBAR® clinical trial was an international, multicenter, randomized, double-blind, with a parallel assignment and placebo-controlled study that enrolled patients with mild and moderate Alzheimer's from 41 treatment centers in Spain and the United States.

The clinical trial was designed to evaluate whether the progression of Alzheimer's could be stabilized through therapeutic plasma exchange, a procedure that entails extracting plasma periodically and infusing a specific albumin solution with or without intravenous immunoglobulin.

AMBAR® entails a multimodal approach to manage the disease, initially based on the hypothesis that most of the amyloid-beta protein –one of the proteins accumulated in the brains of Alzheimer's patients and responsible for brain damage- is bound to another protein, albumin, and circulates in blood plasma. Extracting this plasma and replacing it with an albumin solution may flush amyloid-beta, potentially limiting the disease's impact on the patient's cognitive functions. Additionally, the infused albumin's antioxidant and anti-inflammatory properties may be beneficial for patients.

The trial, which was designed by Grifols in collaboration with Ace Alzheimer Center Barcelona and the Alzheimer's Disease Research Center in Pittsburgh, Pa., U.S., aimed to evaluate the efficacy and safety of plasma exchange with albumin (combined with intravenous immunoglobulin in some treatment arms) in patients with mild and moderate Alzheimer's disease.

The results of the clinical trial have been presented at multiple scientific conferences specializing in Alzheimer's since October 2018 and were published in the prestigious journal Alzheimer's & Dementia: The Journal of the Alzheimer's Association.

The results show the positive effects of the AMBAR® protocol in slowing the cognitive and functional progression of the disease in patients with mild-to-moderate Alzheimer's.