Spanish healthcare company Grifols has reported new results from its Alzheimer Management by Albumin Replacement (AMBAR) clinical trial to treat patients with mild and moderate Alzheimer’s disease.
The trial investigated the safety and efficacy of short-term plasma exchange and subsequent long-term plasmapheresis using a combination of human albumin infusion and intravenous immunoglobulin.
It aimed to determine if plasma exchange could stabilise disease progression in a total of 496 patients aged 55-85. Changes in cognition and daily activity scores were monitored to measure the treatment’s efficacy.
The latest data from the multi-centre, randomised, blinded, placebo-controlled, parallel-group study revealed a statistically significant 61% decrease in disease progression in moderate Alzheimer’s patients who received the AMBAR treatment.
In the same cohort, the therapy demonstrated positive effects on memory, while those with mild disease experienced favourable effects on language and processing speed.
A statistically significant decline of 71% was observed for the Clinical Dementia Rating – Sum of Boxes (CDR-Sb) scale in overall study participants treated with AMBAR, compared to placebo.
When the three treatments arms in the trial were assessed separately, the CDR-Sb significance sustained a decline of between 65% and 71% at 14 months.
Further analysis found a decline of 53% in moderate patients, while mild stage subjects showed an improvement. The company noted that this indicates a higher treatment effect for this endpoint in earlier Alzheimer’s stages.
In addition, a statistically significant stabilisation was reported for the Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) scale in all treated patients versus placebo.
Grifols AMBAR Clinical Program medical director Dr Antonio Páez said: “The new results, together with those presented earlier, show positive effects on the three most important endpoints in Alzheimer’s disease trials: cognition, function, and the combination of both, which is very unique in Alzheimer’s investigation.”
The company presented initial results from the trial at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in Spain last October and at the 14th International Congress on Alzheimer’s and Parkinson’s (AD/PD) in March in Portugal.
The new data has been presented at the Alzheimer’s Association International Conference (AAIC) 2019 in the US.