New data shows positive impact of AMBAR treatment on efficacy endpoints combining cognition and function in all patients treated
The results are in line with the ones presented in CTAD in Barcelona and AD/PD in Lisbon
The results are in line with the ones presented in CTAD in Barcelona and AD/PD in Lisbon
The Grifols Clinical Research team, led by Dr. Antonio Páez, today presented additional results of its AMBAR (Alzheimer Management by Albumin Replacement) clinical trial for the treatment of Alzheimer’s at the Alzheimer’s Association International Conference (AAIC) 2019 in Los Angeles (USA).
The first results were presented at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in Barcelona (Spain) in October 2018 and at the 14th International Congress on Alzheimer’s and Parkinson’s (AD/PD) in Lisbon (Portugal) in March 2019.
These results showed a statistically significant reduction of 61% in disease progression in both primary efficacy endpoints, ADAS-Cog (Alzheimer’s Disease Assessment Scale – cognitive) and ADCS-ADL (Alzheimer’s Disease Cooperative Study – Activities of Daily Living) scales, in the cohort of moderate patients. Regarding specific cognitive aspects, the AMBAR treatment showed positive effects on memory in the moderate patients, and on language and processing speed in patients with the disease in a mild stage.
The additional results presented today at the AAIC point in the same direction in all treated groups across the different relevant endpoints that combine assessments of cognitive status and daily functioning: Clinical Dementia Rating – Sum of Boxes (CDR-Sb) and Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC).
In particular, the CDR-Sb scale — which assesses memory, orientation, judgment, community affairs, home and hobbies, and personal care — shows a statistically significant 71% less decline with respect to placebo in patients treated as a whole. This significance remains when analyzing the three study treatment arms separately, with less decline at 14 months that ranged 65-71%.
Analysis of mild and moderate cohorts displays a statistically significant less decline of 53% in moderate patients and a statistically significant improvement in mild ones, suggesting that for this endpoint the effect of the treatment might be higher in earlier phases of the disease.
For the ADCS-CGIC scale, which assesses several domains of cognition, daily functioning and behavior from both the patient and the caregiver perspective, the results are in line with those of the CDR-Sb scale: a statistically highly significant stabilization is observed in all treated patients with respect to placebo. This effect remains in all three treatment arms when analyzed separately.
As in the case of CDR-Sb scale, the positive and statistically significant effect is also observed for ADCS-CGIC in the moderate-patient cohort. Moreover, there’s a remarkable statistically significant improvement in the mild-patient cohort when compared with placebo at 14 months of treatment. All these effects are replicated when the three treatment arms are assessed against placebo.
At AAIC, Dr. Páez also shared that the plasma amyloid-beta saw-tooth mobilization pattern observed in earlier clinical trials is similar for both conventional and low-volume plasmapheresis performed in the AMBAR trial. This, reinforces the investigational use of smaller volumes of plasma protein replacement therapies.
These encouraging results strengthen Grifols’ commitment in the fight against Alzheimer’s disease. A further update with the complete clinical, biomarker and neuroimaging results will be presented at the CTAD in San Diego (USA) in December 2019.
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