16 March 2017
CANTAB assessments used in EBBINGHAUS cognitive function trial for Amgen’s evolocumab
Cambridge Cognition today reports its involvement in Amgen's EBBINGHAUS study with full results being presented at the American College of Cardiology Annual Scientific Session on 18 March 2017.
Cambridge Cognition reports its involvement in Amgen's EBBINGHAUS study with full results being presented at the American College of Cardiology Annual Scientific Session on 18 March 2017.
The EBBINGHAUS researchers used Cambridge Cognition's CANTAB® digital cognitive assessments, an industry standard for cognitive outcomes measurement. CANTAB products are designed to improve data quality and operational efficiencies in large multinational clinical trials such as this.
Amgen recently announced positive results of the FOURIER and EBBINGHAUS trials evaluating the human anti-PCSK9 monoclonal antibody evolocumab (Repatha®). The EBBINGHAUS trial is the first of its kind to prospectively explore the relationship between very low LDL cholesterol levels and neurocognitive function*.
The FOURIER trial conducted in 27,564 patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) found evolocumab reduced the risk of cardiovascular events, by reducing high levels of LDL cholesterol. The EBBINGHAUS cognitive function trial conducted in a subset of 1,974 FOURIER patients also achieved its primary endpoint, demonstrating that evolocumab was non-inferior to placebo for the effect on cognitive function.
Kenton Zavitz PhD, Director of Clinical Affairs, Cambridge Cognition commented: "By all measures, EBBINGHAUS is a landmark cognitive study. The study involved 1,974 patients across 30 countries worldwide using our tablet-based CANTAB cognitive technology. Researchers were able to reliably assess study subjects for effects on executive function, memory, and psychomotor speed at baseline and select time points. CANTAB software enabled assessments to be carried out in a patient-friendly manner and ensure consistent and reliable data capture that could be translated into meaningful results, without the need for a specialist in neuropsychology at each trial site."
Full results from the evolocumab EBBINGHAUS cognitive function trial will be presented at the American College of Cardiology (ACC) 66th Annual Scientific Session Late-Breaking Clinical Trials session on Saturday, March 18, 2017 at 9 a.m. ET.
*Giugliano R.P., et al. (2017) Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial. Clinical Cardiology, 2017.