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 agematched healthy controls. The trial enrolled over 200 subjects at seven 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.
“We are very pleased to have completed this complex clinical study and are grateful to the clinicians and technicians who were integral to our success,” said Dr. Marco Cecchi, Neuronetrix’s Director of Research and Clinical Affairs. “We look forward to publishing our results which should demonstrate the clinical utility of COGNISION™.” 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. Additional information on the trial can be found at ClinicalTrials.Gov.