AMBAR®: Clinical program
Grifols' commitment to Alzheimer's research began nearly 20 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 2 clinical trial before starting the AMBAR® 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.
It was designed to evaluate whether the progression of Alzheimer's could be stabilized through TPE, a procedure that entails extracting plasma periodically and infusing an albumin solution.
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 encouraging results of the clinical trial have been featured in two articles published in the prestigious journal Alzheimer's & Dementia: The Journal of the Alzheimer's Association, and presented at multiple scientific conferences specializing in Alzheimer's including Clinical Trials on Alzheimer’s Diseases (CTAD), International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) and Alzheimer’s Association International Conference (AAIC).