Grifols demonstrates a significant reduction (61%) in the progression of moderate Alzheimer's disease using its AMBAR treatment protocol
AMBAR, an innovative treatment approach for Alzheimer's disease (AD) based on the combination of Plasmapheresis with Albutein® 20% replacement, may offer a new treatment pathway for the illness in the future.
On October 27, 2018 Grifols presents AMBAR (Alzheimer Management by Albumin Replacement) top line results (phase IIb/III) at the "Clinical Trials on Alzheimer's Disease" (CTAD) congress in Barcelona (Spain).
AMBAR, an innovative treatment approach for Alzheimer's disease (AD) using plasma science has demonstrated, with statistical significance, the ability to slow down the progression of the disease in moderate AD patients.
Presenting the study results, Antonio Páez, M.D., Grifols Medical Director and Head of the AMBAR Clinical Program confirmed that the analysis of AMBAR data in moderate patients has shown positive, highly relevant results in a cohort of patients suffering from moderate Alzheimer's disease.
The combination of Plasmapheresis (a well-known and safe procedure used in plasma exchange) with Albutein® 20% (Albumin - a safe, well tolerated plasma protein with multiple properties) has demonstrated a significant reduction in the progression of the disease in the moderate AD patients participating in the study and may offer a new treatment pathway for the illness.
Results in the pre-specified cohort of moderate AD patients demonstrated a statistically significant reduction of 61% in disease progression from baseline across both primary efficacy endpoints as measured by the Alzheimer's Disease Assessment Scale-cognitive (ADAS-Cog) and the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) scales. While a consistent delay in the progression of disease was observed in the treatment arms for the pre-specified mild cohort (the placebo arm presented a similar pattern), and the difference did not reach statistical significance.
The primary outcomes of the study were the changes from baseline to 14 months in the validated scales of cognition and activities of daily living, ADAS-Cog and ADCS-ADL, respectively. The pre-specified primary analysis was performed on the total study population and included the assessment of the differences to placebo in the primary outcomes of the following study arms: a) three combinations of plasma exchange with albumin and IGIV replacement that shared the same volume of plasma removed (plasmapheresis) regardless of the arm, b) an arm with all patients treated with plasma exchange, and c) an arm that included all patients treated with plasma exchange analyzed by disease severity: mild AD and moderate AD.
In the three-combination arms the differences to placebo showed between 50 and 75% less decline for the ADAS-Cog scale in the treated patients and between 42 and 70% less decline for the ADCS-ADL scale. In the arm with all patients treated with plasma exchange the difference to placebo achieved a 66% less decline for the ADAS-Cog scale in the treated patients with a statistical significance of 0.06 and a 52% less decline for the ADCS-ADL scale with a statistically significant value of 0.03.
In the arm with all patients treated with plasma exchange analyzed by disease severity, patients with mild AD did not decline but the same lack of progression was observed in the placebo group for both ADAS-Cog and ADCS-ADL scales, suggesting that more follow-up time is needed to observe disease progression in milder disease. Conversely, patients with moderate AD treated with plasma exchange showed a 61% less decline compared to placebo for both, ADAS-Cog and ADCS-ADL scales with statistical significances of 0.05 (significant) and 0.002 (highly significant), respectively. In addition, when moderate AD patients were analyzed by plasma exchange combination type, all three combinations achieved statistical significance for ADCS-ADL.
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