The AMBAR study
AMBAR is an international and multicenter clinical trial designed by Grifols in collaboration with Fundació ACE in Barcelona, Spain; and the Alzheimer Disease Research Center in Pittsburgh, PA, U.S. Following a successful pilot, phase 1 and phase 2, phase 2b/3 of the trial aimed to evaluate the efficacy of plasma exchange to slow the progression of Alzheimer's.
Phase 2b/3 of the trial has been carried out in 41 hospitals across the U.S. and Spain, with 496 patients with mild and moderate Alzheimer's taking part. The study was double-blind –neither patients nor evaluators knew who was receiving which treatment– and placebo-controlled.
AMBAR was designed to evaluate the efficacy of plasma exchange using different replacement volumes and concentrations of albumin.
The treatment lasted 14 months and was split into two phases: an initial phase common to all patients, followed by a second phase in which different volumes and concentrations of albumin were administered to different groups. In some cases, the albumin was alternated with intravenous immunoglobulin to correct a possible endogenous immunoglobulin decrease. The plasma exchange in placebo-controlled group was simulated in both phases.
The primary objectives were to evaluate the efficacy of the treatment by measuring variations in the patients' cognitive function and ability to carry out daily activities.
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Clinical Study Design
The video explains the characteristics of the study and how the clinical trial has been carried out.
