Evaluation of a Handheld Event-Related Potential (ERP) System as an Effective Method to Diagnose Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	Neuronetrix, Inc. University of Kentucky
Information provided by:	Neuronetrix, Inc.
ClinicalTrials.gov Identifier:	NCT00582127

Purpose

This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to screen elderly adults for Alzheimer's disease or other age-related dementias.

An ERP system records electrical signals at the scalp that are produced by the brain when performing simple tasks. By doing this study, we hope to learn whether these electrical signals can be used to differentiate normal aging from dementia.

Condition
Alzheimer's Disease

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Validation Study of the Neuronetrix COGNISION(TM) System as an Early Screening Test for Alzheimer's Disease and Other Age-Related Dementias.

Further study details as provided by Neuronetrix, Inc.:

Primary Outcome Measures:

Complete ERP tests along with automated classifier training with all subjects. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To perform statistically significant classifications for the 2 cohorts. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Mild-moderate Alzheimer's Disease
2 Age-matched Controls

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. A headset on each subject's head will then record the electrical signals during this task.

Eligibility

Ages Eligible for Study:	65 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients and family from the University of Kentucky Sanders Brown Center for Aging

Criteria

Inclusion Criteria:

Age 65 to 85
Mild to moderate diagnosis of Alzhiemer's disease

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582127

Locations

United States, Kentucky
Sanders Brown Center for Aging, Neurology Dept.
Lexington, Kentucky, United States, 40506

Sponsors and Collaborators

Neuronetrix, Inc.

University of Kentucky

Investigators

Principal Investigator:

Charles D Smith, M.D.

University of Kentucky

More Information

Additional Information:

Website for manufacturer of COGNISION(tm) System being tested This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2006 Sep 20.

Responsible Party:	University of Kentucky ( Charles D. Smith, M.D. )
Study ID Numbers:	VAL-UK-01
Study First Received:	December 19, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00582127 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Neuronetrix, Inc.:

senile
dementia

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009