Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease.
Condition: Memory Disorders; Alzheimer Disease; Dementia; Cognitive Impairment; Frontotemporal Dementia
MeSH terms: Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Memory Disorders
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): COGNISION™ System
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects between 60 and 90 years old meeting DSM-IV criteria for dementia of the
        Alzheimer's type and NINCDS-ADRDA criteria for probable AD will be recruited in the AD
        cohort. Matched cognitively healthy volunteers will be recruited for the Control group.
      
Biospecimen description: 
      1. These lab tests will be performed from a standard blood draw:

             1. B12

             2. TSH

             3. CRP

             4. ALT

             5. HGB

             6. Hgb1AC

             7. T4

             8. Na

             9. K

            10. Cl

            11. CO2

            12. ApoE

            13. Platelet Count

            14. INR

            15. PT

        2. MRI- INCLUDING VOLUMETRY

        3. CSF 5ML (Optional)
    
Keywords: Alzheimer; Memory disorder; dementia; cognitive behavioral decline; vascular dementia; front temporal dementia