US-based Neuronetrix has completed a significant clinical study milestone involving their proprietary Cognision system.
The multi-year study was designed to evaluate the system’s ability to discriminate early stage Alzheimer’s patients from age-matched healthy controls.
The trial enrolled over 200 subjects at 7 sites in the US. During the trial, the Cognision system recorded cognitive brainwave activity from patients with mild Alzheimer’s disease and from healthy subjects. The brainwave data was then compared to standard clinical criteria for the diagnosis of Alzheimer’s disease.
The study also included a testing protocol from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) that consisted of psychological tests, lab tests, DNA sequencing, and MRI. Correlations between these biomarkers and the Cognision test data are being developed.
Neuronetrix Research and Clinical Affairs director Dr Marco Cecchi noted the company is very pleased to have completed this complex clinical study and are grateful to the clinicians and technicians who were integral to its success.
"We look forward to publishing our results which should demonstrate the clinical utility of Cognision," Dr Cecchi added.
In November 2013, positive preliminary data from the study were presented at the Clinical Trials for Alzheimer’s Disease (CTAD) conference in San Diego. The completed analysis and study conclusions will be submitted for peer reviewed publication in the coming months.
The Cognision system is a proprietary neuro-electrophysiological device which provides objective assessments of cognitive function. Cognision implements validated scientific methods in a practical, cost effective, and easy to use design.