Alzheimer's Disease Education and Referral Center

COGNISION™ as a Useful Cognitive Biomarker for Alzheimer's Disease

COGNISION™ as a Useful Cognitive Biomarker for Alzheimer's Disease

Overall Status: 
Completed
Brief Description: 

The proposed study is designed to evaluate the performance of the COGNISION™ system as a tool to assist physicians in diagnosing Alzheimer's disease in real-world clinical settings.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
60 Years
90 Years
Both
Yes
Inclusion Criteria: 

    Participants with Alazheimer's Disease

    • Age 60-90
    • Meet criteria for probable Alzheimer's disease, with memory complaint by subject and/or study partner
    • Clinical Dementia Rating (CDR) = 0.5, 1.0 or 2.0; Modified Hachinski Ischemic Scale ≤4; Geriatric Depression Scale <6
    • Study partner or caregiver to accompany subject to all scheduled visits
    • Fluent in English
    • Adequate seeing and hearing ability to allow neuropsychological testing
    • Good general health with no additional diseases expected to interfere with the study

    Normal Controls

    • Normal memory function
    • Fluent in English
    • Adequate seeing and heairng ability to allow neuropsychological testing
Exclusion Criteria: 

    Participants with Alzheimer's Disease

    • Severe or unstable medical conditions (e.g., diabetes, heart disease, HIV, drug or alcohol abuse)
    • Severe Alzheimer's disease (MMSE ≤20) or other dementias
    • Medical or psychiatric disorders that might complicate the assessment of dementia (i.e., mental retardation, alcohol abuse, drug abuse, HIV)
    • Disability that may prevent the subject from completing all study requirements
    • Recent intake of drugs known to cause major organ system toxicity or central nervous system alteration
    • Presence of non-MRI compatible implants/devices
    • Prohibited medications: Investigational agents

    Normal Controls

    • Severe or unstable medical conditions (e.g., diabetes, heart disease, HIV, drug or alcohol abuse)
    • Disability that may prevent the subject from completing all study requirements
    • Use of psychoactive drugs (only SSRIs are allowed)
    • Psychiatric disorders, depression, dementia
    • Abnormal memory function
    • Prohibited medications: Psychoactive drugs
Detailed Description: 

The primary goals of this study are to evaluate the COGNISION system's ability to perform tests, collect data, and diagnose AD. COGNISION is a noninvasive electroencephalographic (EEG) device that measures electrical signals at the scalp. The brain produces these signals when performing tasks called "event-related potentials," or ERP. In this study, investigators will determine whether the electrical signal "signatures" of Alzheimer's disease can be distinguished from normal brain signals to permit a diagnosis of dementia.

During the 45- to 60-minute ERP procedure, participants will wear headphones and electrodes. They will respond to a series of tones and perform other exercises. Each study site will evaluate between 25 and 50 individuals, evenly divided between people with Alzheimer's and age-matched controls. The cohort of Alzheimer's patients will be evenly divided between individuals who do and do not take cholinesterase inhibitors.  

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Name:
Phone:

Geolocation is 38.0328237, -84.5067424

Site
Lexington
Kentucky
40536
Name:
Phone:

Geolocation is 38.2556928, -85.751283

Site
Louisville
Kentucky
40202
Name:
Phone:

Geolocation is 42.3178198, -71.1626756

Site
Brookline
Massachusetts
02467
Name:
Phone:

Geolocation is 36.0038131, -78.9387241

Site
Durham
North Carolina
27710
Name:
Phone:

Geolocation is 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Name:
Phone:

Geolocation is 42.878094, -73.1968001

Site
Bennington
Vermont
05201
Name:
Phone:
Lead Sponsor: 
Agency
Neuronetrix, Inc.
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Charles D. Smith, MD
Principal Investigator
Univeristy of Kentucky
Murali Doraiswamy, MD
Principal Investigator
Duke University
Steven E. Arnold, MD
Principal Investigator
University of Pennsylvania
Paul R. Solomon, PhD
Principal Investigator
The Memory Clinic, Bennington VT
Bradley S. Folley, PhD
Principal Investigator
Norton Healthcare, Louisville KY
Carl Sadowsky, MD
Principal Investigator
Premiere Research Institute, West Palm Beach FL
Andrew E. Budson, MD
Principal Investigator
Boston Center for Memory
Study Contact: 
NamePhonePhone ExtEmail
KC Fadem
502-561-9040
x108
Locations
 
 
ClinicalTrials.gov ID 
NCT00938665 (follow link to view full record on ct.gov in new window)
Official Title: 
Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease.
Study Start Date: 
December 2010
Study End Date: 
December 2013
Disease Stage: 
Early
Middle
Enrollment: 
200