Plasma exchange combined with albumin therapy: reducing the progression of moderate Alzheimer's disease

Recently, Grifols, a Spanish company, released the top line data for the Phase IIb/III AMBAR study of albumin replacement therapy in patients with moderate Alzheimer's disease (AD). The results were presented at this year's Alzheimer's Clinical Trials Conference (CTAD).

AMBAR is a multicenter, randomized, blinded, and placebo-controlled clinical trial involving mild to moderate Alzheimer's patients from 41 treatment centers in Europe and the United States. The aim of this study is to evaluate the efficacy and safety of short-term and long-term plasma exchange (a safe and reliable method for plasma exchange) combined with human serum albumin 20% (a safe, well tolerated, and multi characteristic plasma protein) and intravenous immunoglobulin infusion in the treatment of mild to moderate Alzheimer's disease.

The results of this clinical study show that the combination of plasma exchange and 20% human serum albumin significantly reduces disease progression in moderate AD patients, providing a potential new treatment approach for the disease.

In a pre queue of moderate AD patients, the primary efficacy endpoints evaluated based on the Alzheimer's Disease Assessment Scale Cognitive Scale (ADAS Cog) and Alzheimer's Disease Activities of Daily Living Scale (ADCS-ADL) showed a significant 61% reduction in disease progression compared to baseline levels. In the pre mild cohort, the treatment group observed a sustained delay in disease progression (the placebo group showed a similar pattern), and the difference between the two did not reach statistical significance.

The main endpoint of the study was the changes in cognitive validation and daily living ability scales (ADAS Cog and ADCS-ADL) from baseline to 14 months. A preliminary analysis was conducted on all study patients, and an evaluation of placebo differences was included in the main outcomes of the following three groups of studies: 1. Three combinations of plasma exchange with albumin and IGIV exchange; 2. Treat all patients with plasma exchange; 3. Include all patient groups receiving plasma exchange therapy, and analyze according to the severity of the disease (mild, moderate).

In the three combination treatment groups, the difference from placebo showed that the ADAS Cog scale in the treatment group decreased by 50% -75%, and the ADCS-ADL scale decreased by 42% -70%. Among all patients receiving plasma exchange therapy, the ADAS Cog score in the treatment group decreased by 66% (p=0.06) and the ADC-ADL scale decreased by 52% (p=0.03) compared to placebo. According to the severity analysis of the disease, there was no decrease in mild AD patients, but the placebo group showed a lack of progression on both ADAS Cog and ADCS-ADL scales, indicating the need for more follow-up time to observe the progression of mild disease patients. On the contrary, compared with placebo, moderate AD patients treated with plasma exchange showed a 61% decrease in ADAS Cog and ADCS-ADL (p=0.05 and 0.002). In addition, when conducting plasma exchange combined with type analysis on patients with moderate AD, all three combinations showed statistical significance for ADCS-ADL.

Oscar Lopez, director of Alzheimer's disease research at the University of Pittsburgh, said, "The observed results in moderate patients are remarkable and open up new avenues for the treatment of neurodegenerative diseases, representing a new model for Alzheimer's disease treatment

Grifols Chairman V í ctor Gr í fols Roura said, "These results open a new chapter in the treatment of Alzheimer's disease, and Grifols will continue to explore the potential of plasma protein and plasma exchange therapies. ”(Biological Valley)