On 16 July, the Spanish multinational pharmaceutical and chemical manufacturer Grifols presented additional data of its AMBAR Phase IIb/III clinical trial for the treatment of Alzheimer's disease (AD) at the Alzheimer’s Association International Conference (AAIC) in Los Angeles.
The multicenter, randomised and controlled AMBAR study is based on the hypothesis that most of the amyloid-beta protein is bound to albumin and circulates in the plasma. The study was designed to determine whether the progression of AD could be stabilised through plasma exchange, a process that extracts plasma and replaces it with infusion of human albumin combined with intravenous immunoglobulin. The study included almost 500 people with mild and moderate AD in Spain and the US.
The data presented showed that in the primary endpoints there was a 61% statistically significant reduction in disease progression in participants with moderate AD. Additional findings showed positive change in assessments of cognitive status and daily functioning in all treated participants. A statistically significant 71% less decline in treated participants compared to those who received the placebo was observed on the CDR-Sb scale, which assessed memory, orientation, judgment, community affairs, home and hobbies and personal care. On the ADCS-CGIC scale, which assesses cognition, daily functioning and behaviour, researchers noted a significant improvement in treated participants compared with placebo.
Additional results will be presented at the 12th Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego in December 2019.