Clinical trial NCT00582127: Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
Official title: Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: senile
dementia
Lead sponsor: Neuronetrix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Kentucky
First posted: 2007-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and family from the University of Kentucky Sanders Brown Center for Aging

Brief summary: 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.

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:

1. Patient tolerance
2. Ease of use
3. Data quality
4. Network architecture

Eligibility criteria: 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

Primary outcomes:
measure: Signal to noise ratio (SNR) of ERPs
timeFrame: 9 months
Secondary outcomes:
measure: Patient tolerance of the COGNISION(TM) system.
timeFrame: 9 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Sanders Brown Center for Aging, Neurology Dept.
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Charles D Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polikar R, Topalis A, Green D, Kounios J, Clark CM. Comparative multiresolution wavelet analysis of ERP spectral bands using an ensemble of classifiers approach for early diagnosis of Alzheimer's disease. Comput Biol Med. 2007 Apr;37(4):542-58. doi: 10.1016/j.compbiomed.2006.08.012. Epub 2006 Sep 20.