MedTrace Logo

Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease.

NCT00938665 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 204

Last updated 2014-03-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

COGNISION™ System

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.

Sponsors & Collaborators

  • Neuronetrix, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles D Smith, MD · Univeristy of Kentucky

  • Murali Doraiswamy, MD · Duke University

  • Steven E Arnold, MD · University of Pennsylvania

  • Paul R Solomon, PhD · The Memory Clinic, Bennington VT

  • Bradley S Folley, PhD · Norton Healthcare, Louisville KY

  • Carl Sadowsky, MD · Premiere Research Institute, West Palm Beach FL

  • Andrew E Budson, MD · Boston Center for Memory

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00938665 on ClinicalTrials.gov