May 19, 2021
Grifols takes another step in the fight against Alzheimer’s, partners with Ace to open first AMBAR® Center in Barcelona
The center will collect real-world data on AMBAR® clinical program
- AMBAR® Center combines Grifols’ more than 15 years of knowledge researching this devastating disease with the experience of the non-profit medical foundation Ace Alzheimer Center Barcelona in diagnosing and treating Alzheimer’s patients, including application of AMBAR® (Alzheimer Management by Albumin Replacement)
- The AMBAR® clinical program, based on periodic plasma exchange with albumin, has shown a delay in the cognitive and functional progression of Alzheimer’s disease in mild-to-moderate patients
- Ace Alzheimer Center will manage the center, to be located on its premises in Barcelona. Grifols will partner with other leading medical institutions to open expected future centers in the EU, U.S. and China, obtaining AMBAR® data from clinical practice and advancing further in the therapeutic management of the disease
Barcelona, Spain, May 19, 2021 – Grifols (MCE: GRF, MCE: GRF.P, and NASDAQ: GRFS), a leading global producer of plasma-derived medicines with a history of more than 110 years contributing to improve the health and well-being of people, today announced it’s collaborating with the medical foundation Ace Alzheimer Center Barcelona to open the first AMBAR® Center, where AMBAR® procedure for Alzheimer’s disease will be applied to obtain data from clinical practice.
This next phase in the fight against Alzheimer’s will serve to optimize the application of AMBAR® in medical practice and make it a new option for suitable patients as soon as possible. It comes after more than 15 years of advancing Alzheimer’s research through the AMBAR® clinical program, which includes an international clinical study demonstrating that periodic plasma exchange with albumin safely slows the cognitive and functional progression of Alzheimer’s in mild-to-moderate patients.
The overall patient experience at AMBAR® Center will combine the know-how that Grifols has accumulated as developer of AMBAR® with Ace Alzheimer Center’s expertise in diagnosing and treating Alzheimer’s patients, as well as in basic and applied research. Its knowledge also includes applying AMBAR® through its participation in the development of the clinical program since it began in 2004.
AMBAR® Center will be located at Ace’s facilities in Barcelona and managed by its healthcare professionals including neurologists, neuropsychologists, apheresis specialists and nurses trained and experienced in AMBAR®.
“AMBAR® Center will obtain medical data to optimize the application of the innovative AMBAR® procedure and reinforce its robustness,” said Dr. Antonio Páez, Medical Director of the AMBAR® Clinical Program at Grifols. “Grifols is very pleased that its longtime collaborator Ace Alzheimer Center Barcelona, with its vast experience caring for Alzheimer’s patients as well as its working knowledge of AMBAR®, will manage the first center.”
According to Dr. Mercè Boada, neurologist and co-founder of Ace: “We have worked closely with Grifols since the beginning of the AMBAR® clinical program and are excited that AMBAR® is taking this important next step of obtaining data through regular clinical practice. This will build on the important work of Ace Alzheimer Center Barcelona, which throughout our more than 25 years has been first and foremost about global, personalized care and attention for our patients and their families as they cope with Alzheimer’s.”
Grifols plans to open additional AMBAR® Centers in the EU, U.S. and China. It will partner with leading medical institutions distinguished for their work in Alzheimer’s, a disease that currently affects more than 35 million people worldwide.
Stated Victor Grifols Roura, president of Grifols: “Since the beginning of the AMBAR® program our overriding objective has been to find a treatment for Alzheimer’s disease and to help patients, their families and society fight this awful condition. With the opening of our first AMBAR® Center and the expectation to open more, we are closer to this goal and we will continue to work to accomplish it.”
About AMBAR® study
AMBAR® (Alzheimer Management by Albumin Replacement) study is an international, multicenter, randomized, double-blind, placebo-controlled, with parallel assignment clinical trial that enrolled patients with mild and moderate Alzheimer’s from 41 treatment centers in Spain and the United States.
The study was designed to evaluate the efficacy and safety of therapeutic plasma exchange with albumin replacement.
AMBAR® study targets a multimodal approach to the management of the disease 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, thus limiting the disease's impact on the patient's cognitive functions. Additionally, albumin has antioxidant, immunomodulatory and anti-inflammatory properties.
The AMBAR® study included 496 patients aged 55 to 85 years, randomized in three treatment groups and one control (placebo) group. 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. Results were published in July 2020 in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association1.
Grifols began its research on Alzheimer's disease in 2004, with several preclinical trials, two pilot studies and a Phase II clinical trial before launching the AMBAR® trial.
Ace Alzheimer Center and the Alzheimer’s Disease Research Center of the University of Pittsburgh, Pa., USA, have been instrumental partners in the AMBAR® research and in Grifols’ Alzheimer’s program since its initiation in 2004.
1Boada, M., López, O. L., Olazarán, J., Núñez, L., Pfeffer, M., Paricio, M., Lorites, J., Piñol-Ripoll, G., Gámez, J. E., Anaya, F., Kiprov, D., Lima, J., Grifols, C., Torres, M., Costa, M., Bozzo, J., Szczepiorkowski, Z. M., Hendrix, S., & Páez, A. (2020). A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study. Alzheimer's & Dementia, 16(10), 1412–1425 https://doi.org/10.1002/alz.12137