Date: 2012-07-02
Type of information:
phase:
Announcement: launch of the study
Company: Grifols (Spain)
Product: combined treatment with albumin plasmapheresis and intravenous immunoglobulin (IVIG) at different doses
Action mechanism:
Disease: Alzheimer\'s disease
Therapeutic area: Neurodegenerative diseases
Country: Spain, USA
Trial
details: The AMBAR study (“Alzheimer Management By Amyloid Removal”) will involve around 350 patients.
This multi-center study will be conducted in hospitals in Spain and the United States and will include Alzheimer’s patients at the mild to moderate stage of the disease, randomly grouped into three treatment branches and a fourth control group. The estimated duration of the study is two years. AMBAR will be directed by Dr. Mercè Boada, medical director of Fundació ACE and clinical head of the Neurology Service of the Vall d’Hebron Hospital in Barcelona.
Latest
news: Grifols, the world’s third-largest plasma derivatives company and a pioneer in the research and development of therapeutic applications of plasma proteins, has launched a study into the treatment of Alzheimer’s disease involving around 350 patients. The AMBAR study trials combined treatment with albumin plasmapheresis and intravenous immunoglobulin (IVIG) at different doses.
The study seeks to identify synergies between the two treatments, with the aim of reducing both the frequency and the volume of plasmapheresis, to make the treatment experience more pleasant for the patient and easier for medical staff to administer. Grifols has worked with the American company Fenwal to develop the prototype of a plasmapheresis machine specially adapted to meet this requirement, which will be validated as part of the study.
In September 2009, Grifols published partial results - in 29 patients out of a total of 42 - of a preliminary trial conducted in two hospitals in Spain and two in the United States, showing a tendency for the disease to stabilize. The complete results of the preliminary trial were presented at the 8th Barcelona-Pittsburgh Biennial Conference “Dementia today” (May 23-25, 2012, Barcelona) organized by the Fundació ACE, Barcelona Alzheimer Treatment & Research Center (Dr. Mercè Boada) and the Alzheimer Research Center of the University of Pittsburgh (Dr. Óscar López) before an international audience of 400 delegates.
