Neuronetrix begins pivotal multicentre clinical trial of Alzheimer’s diagnostic device


Neuronetrix has announced the first test of the Cognision System as part of the company’s pivotal multicentre clinical trial.

The first subject was tested on 10 December at the University of Kentucky’s Sanders-Brown Alzheimer’s Disease Center. The multicentre study will evaluate Neuronetrix’s proprietary Cognision System as a practical non-invasive test for the early detection of Alzheimer’s disease.

In the ongoing study, dementia subjects who are presumed to have Alzheimer’s disease will be evaluated using a number of research protocols including magnetic resonance imaging (MRI), cerebrospinal fluid (CSF) analysis, and a battery of psychometric tests. The dementia subjects will then undergo the 30-minute Cognision Test which involves recording brainwaves while the subject listens to a series of auditory stimuli. Healthy control subjects will undergo a brief psychometric exam and then take the Cognision Test. The Cognision Software will then be trained to distinguish a healthy subject from one who might have Alzheimer’s disease.

“While several new technologies are being evaluated as diagnostic biomarkers of Alzheimer’s disease including PET imaging, MRI volumetry, and CSF analysis, only Cognision holds the potential of a practical, reliable, and inexpensive Alzheimer’s test which can be administered in a doctor’s office,” said KC Fadem, president of Neuronetrix.

To ensure that the Cognision System is capable of acquiring the same quality data independent of study site or staff, the same study protocols will be performed at other clinical sites including Duke University, The Memory Clinic in Bennington Vermont, and two other centres in the USA. A total of approximately 240 subjects will be included in the study which is expected to last 12-18 months.

“We have been working with our clinical study partners for almost three years to design this very complex study and we are very excited to have finally tested subject one,” said Mauktik Kulkarni, director of Research & Clinical Affairs of Neuronetrix.