FDAnews Device Daily Bulletin

Neuronetrix Completes Study of Alzheimer’s Detection System

Feb. 14, 2014

Neuronetrix said Wednesday it has reached a significant milestone in completing the data collection phase of a multi-year observational study evaluating the Cognision system for the detection of early-stage Alzheimer’s disease.

The trial included more than 200 patients ages 60 to 85 at seven sites across the U.S. Investigators used the Cognision system to record brainwaves from patients with mild Alzheimer’s disease and from healthy patients, and then compared that data to standard clinical criteria used in diagnosing Alzheimer’s. The study participants also underwent DNA sequencing, psychological tests, lab tests and MRIs, as dictated by the Alzheimer’s Disease Neuroimaging Protocol.

Cognision consists of a wireless, battery-powered headset and a controller that uses the company’s reCognision pattern-recognition software. The device performs validated QEEG and ERP tests in a physician’s office in a manner designed to overcome the clinical difficulties of size, accuracy and reliability inherent in such tests, Neuronetrix claims.

The Louisville, Kty., devicemaker presented positive preliminary data from the study in November. That information will be added to the results from the completed study and published in coming months, Neuronetrix said. — Lena Freund

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