An American neurotech company, Neuronetrix, has just announced the completion of a significant clinical study milestone for early diagnosis of Alzheimer’s disease, involving its own COGNISION System, a neuro-electrophysiological device which provides assessments of cognitive function. 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.
“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.”