The proposed study is designed to evaluate the performance of the COGNISION™ System as a tool to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings. The design of this study is guided by two overriding factors: 1) to optimize the performance of the event related potentials (ERP) classifiers, the subjects making up the training sets must be well characterized as to their clinical diagnosis, and 2) all ERP tests must be performed and reproduced in real-world clinical settings.
The study will be : A. Multi-Center Study: primary goal of this study will be to evaluate the COGNISION™ Platform across multiple study locations. This will demonstrate an ability to perform tests, collect data, and generate classifications irrespective of variations in testing locations and personnel. 1. 5-8 study sites will be selected with each site being a recognized NIH Center of Excellence for Alzheimer's disease or other nationally recognized Alzheimer's disease research center. 2. Each site will evaluate up to 60 subjects evenly divided between AD patients and age-matched controls (while the prevalence of AD is approximately 2% in the general population, the ratio of AD to normal among those who visit a clinic for memory or cognitive related issues is between 50-60%). 3. Each site will follow the same testing protocols. 4. All test data will be uploaded to the online COGNISION™ database server.
Study Type
OBSERVATIONAL
Enrollment
204
30 minute ERP test and 3 minute resting EEG data collected from cognitively healthy and AD to validate ERP and qEEG as useful cognitive biomarkers for AD.
Premiere Research Institute
West Palm Beach, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare
Louisville, Kentucky, United States
Boston Center for Memory
Brookline, Massachusetts, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Memory Clinic
Bennington, Vermont, United States
Electrophysiological markers of cognitive status
Time frame: Markers are collected at study visit
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