AMBAR results published
in Alzheimer's & Dementia

Grifols' commitment to Alzheimer's disease research began more than fifteen years ago, when the company decided to explore the potential of plasma therapies in the treatment of this devastating neurodegenerative disease.

AMBAR (Alzheimer Management by Albumin Replacement) represents one of our most ambitious clinical trials to date.

Grifols began its Alzheimer's clinical research program in 2004 with two studies, a pilot study with 10 patients and a phase 2 study with 42 patients, investigating the potential of plasma exchange with albumin to reduce the progression of Alzheimer's disease in mild-to-moderate stage patients.²

After the first encouraging results from these studies, in 2011 the company began an ambitious international clinical trial: AMBAR (Alzheimer Management by Albumin Replacement) in collaboration with the Fundació ACE (Alzheimer Centre Educacional) in Barcelona and the Alzheimer Disease Research Center at the University of Pittsburgh, USA. The trial evaluated the efficacy of the plasma exchange protocol with albumin, with or without immunoglobulin, for 14 months in the progression of Alzheimer's disease in mild and moderate stage patients.^3,4

Almost 500 patients with Alzheimer's disease from 41 hospitals in the United States and Spain participated in AMBAR.

The results of the clinical trial have been presented at multiple scientific conferences specializing in Alzheimer's in the last year and a half and were recently published in the prestigious journal Alzheimer's & Dementia: The Journal of the Alzheimer's Association.⁵

The results show the positive effects of the AMBAR protocol in slowing the cognitive and functional progression in patients with mild-to-moderate Alzheimer's disease during the treatment period. These findings indicate that plasma therapies may have a potential role in the treatment of Alzheimer's disease.

At the same time and parallel to the clinical research, Grifols is developing distinct lines of non-clinical research whose aim is to understand the mechanisms associated with plasma protein replacement therapy and the role of albumin in Alzheimer's disease.

In the last 15 years, Grifols has invested more than 150 million euros in Alzheimer's disease research projects, which, in addition to AMBAR, include innovative projects focused on early diagnosis and research into a preventive vaccine.

References

¹World Health Organization (19 September 2019). Dementia. https://www.who.int/news-room/fact-sheets/detail/dementia 
²Boada, M., Ortiz, P., Anaya, F., Hernández, I., Muñoz, J., Núñez, L., Olazarán, J., Roca, I., Cuberas, G., Tárraga, L., Buendia, M., Pla, R. P., Ferrer, I., & Páez, A. (2009). Amyloid-targeted therapeutics in Alzheimer's disease: use of human albumin in plasma exchange as a novel approach for Abeta mobilization. Drug News & Perspectives, 22(6), 325–339. https://doi.org/10.1358/dnp.2009.22.6.1395256 
³Instituto Grifols, S.A., Grifols Biologicals, LLC. (2012). A study to evaluate albumin and immunoglobulin in Alzheimer's disease (AMBAR). Identifier: NCT01561053. https://clinicaltrials.gov/ct2/show/NCT01561053
⁴Boada, M., López, O., Núñez, L., Szczepiorkowski, Z. M., Torres, M., Grifols, C., & Páez, A. (2019). Plasma exchange for Alzheimer's disease Management by Albumin Replacement (AMBAR) trial: Study design and progress. Alzheimer's & dementia (New York, N. Y.), 5, 61–69. https://doi.org/10.1016/j.trci.2019.01.001  
⁵Boada, 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