- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00582127
Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease
This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.
An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. By doing this study, we hope to evaluate various performance parameters of the COGNISION(TM) system.
Study Overview
Status
Conditions
Detailed Description
Patients who have a current diagnosis of mild-moderate dementia and suspected of having Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited for this study. The Alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study.
Both groups, AD and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each subject's head will then record the electrical signals during this task.
Four important features of the COGNISION(TM) will be investigated:
- Patient tolerance
- Ease of use
- Data quality
- Network architecture
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40506
- Sanders Brown Center for Aging, Neurology Dept.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for AD:
- Age 60 to 85
- Mild to moderate diagnosis of Alzhiemer's disease
Inclusion Criteria for Control:
- Age 60 to 85
- Cognitively healthy with no complaints
Exclusion Criteria:
- Subjects with advanced AD and severe impairment (CDR > 2, MMSE less than 15)
- Neurological disorders such as stroke, Parkinson's disease, Huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia)
- Subjects with life threatening illnesses and subjects with significant hearing or visual impairments
- Subjects with a current prescription for psychoactive pharmaceuticals
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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1
Mild-moderate Alzheimer's Disease
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2
Age-matched Controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Signal to noise ratio (SNR) of ERPs
Time Frame: 9 months
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9 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient tolerance of the COGNISION(TM) system.
Time Frame: 9 months
|
9 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles D Smith, M.D., University of Kentucky
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAL-UK-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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