Alzheimer Disease Clinical Trial
Official title:
Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease.
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.
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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