Researchers at the University of Kentucky’s Sanders-Brown Center on Aging, Lexington, KY and Duke University, Durham, NC have signed contracts with Neuronetrix, Inc. to initiate a multi-center clinical trial to evaluate brainwaves as a method to diagnose Alzheimer’s disease. The COGNISION™ System, an innovative platform developed by Neuronetrix, enables objective assessment of cognitive function in a primary care setting using a technology called eventrelated potentials (ERP’s). Previous scientific studies have demonstrated that ERP’s can be used as an inexpensive and non-invasive tool for early detection of Alzheimer’s.
The new study is expected to validate these scientific studies in a real-world, multi-center environment. Over the next 12-18 months, 200 elderly volunteers will be recruited at 4-6 sites across the United States. Drs. Charles Smith and Gregory Jicha, both faculty members at the Department of Neurology at the University of Kentucky (UK), will spearhead the effort. Dr. P. Murali Doraiswamy at the Department of Psychiatry will lead the investigation at Duke University. Additional centers will be added in the coming months. ERP’s will be recorded from subjects’ scalps while they listen to a specific sequence of sounds. These ERP’s will be used to train a computer to distinguish subjects with Alzheimer’s from healthy volunteers. This clinical trial builds on an earlier pilot study in which the portable COGNISION™ System was tested at UK for data quality, ease-of-use and patient tolerance.
What sets our study apart from previous ERP studies in Alzheimer’s patients is the rigorous clinical evaluation we will be performing on our subjects. This includes an extensive battery of advanced diagnostic tests to isolate Alzheimer’s patients from those with other types of dementia. This is critical in developing the high diagnostic accuracy we expect from our COGNISION™ System,‖ says Mauktik Kulkarni, Director of Research and Clinical Affairs at Neuronetrix.
The COGNISION™ test is expected to be the first objective functional biomarker to be approved for early detection of Alzheimer’s disease. ―The primary goal of our upcoming study is to replicate the high classification accuracy for Alzheimer’s reported by Dr. Robi Polikar, one of our scientific advisors. We are looking forward to the study because the reported accuracy of ERP’s is significantly higher than that observed in primary care centers. In addition, the secondary endpoints will give us clues about the utility of the COGNISION™ System in separating different types of dementias and monitoring the effects of experimental Alzheimer’s drugs,‖ says K.C. Fadem, COO of Neuronetrix.