Last week, at the Society for Neuroscience Conference in Washington DC, Neuronetrix announced preliminary results from a clinical study of their COGNISION System to diagnose Alzheimer's disease.
The study was performed with Alzheimer's patients at the University of Kentucky's Sanders-Brown Center for Aging.
The COGNISION System uses event-related potentials (ERP) to record brain activity while the patient listens to a sequence of sounds. Subjects with Alzheimer's process auditory information differently than healthy individuals and that difference can be detected with the test.
The ability of the ERP method to diagnose Alzheimer's disease has been demonstrated in scientific studies at several research laboratories around the world. In a scientific paper published in 2007, Neuronetrix collaborators Drs. Robi Polikar, et al, reported that their ERP classification accuracy "exceeded that of the trained community clinic physicians, and closely approached the gold standard performance of the university hospital-based clinic evaluation."
This phase of the study was primarily performed to evaluate the COGNISION System in a real-world clinical setting to test ease of use, patient tolerance, and most importantly, data quality.
"Clinical usability and technical performance were major milestones in our study at the Sanders-Brown Center." "The system exceeded our expectations in terms of data quality and we demonstrated the test could be efficiently performed on real Alzheimer's patients." K.C. Fadem, Neuronetrix, Inc.
The next clinical study phase for Neuronetrix will be to test the COGNISION System in a multi-center trial on patients who have been diagnosed with Alzheimer's disease using a rigorous diagnostic protocol. This protocol will be similar to that used in the Alzheimer's Disease Neuroimaging Initiative (ADNI), a large international study sponsored by the US National Institutes of Health (NIH).
The ADNI protocol uses psychometric testing, magnetic resonance imaging (MRI), and cerebrospinal fluid analysis (CSF) to accurately characterize several aspects of Alzheimer's disease. Neuronetrix will use these same tests to correlate with the COGNISION ERP results.
"We want to compare our COGNISION System with the most advanced diagnostic methods possible to clearly demonstrate the system's capabilities." Dr. John Barker, Chairman, Neuronetrix, Inc.
Neuronetrix is currently working with several NIH Center's of Excellence in the US and a center in Europe to organize the study which is expected to begin in the first quarter of 2009.