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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuronetrix, Inc.
ClinicalTrials.gov Identifier:
NCT00938665
First received: July 13, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Memory Disorders
Alzheimer Disease
Dementia
Cognitive Impairment
Frontotemporal Dementia
Device: COGNISION™ System

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease.

Resource links provided by NLM:


Further study details as provided by Neuronetrix, Inc.:

Primary Outcome Measures:
  • Electrophysiological markers of cognitive status [ Time Frame: Markers are collected at study visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
  1. These lab tests will be performed from a standard blood draw:

    1. B12
    2. TSH
    3. CRP
    4. ALT
    5. HGB
    6. Hgb1AC
    7. T4
    8. Na
    9. K
    10. Cl
    11. CO2
    12. ApoE
    13. Platelet Count
    14. INR
    15. PT
  2. MRI- INCLUDING VOLUMETRY
  3. CSF 5ML (Optional)

Enrollment: 204
Study Start Date: December 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control Group 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.
AD Group 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.

Detailed Description:

The study will be :

A. Multi-Center Study:

primary goal of this study will be to evaluate the COGNISION™ Platform across multiple study locations. This will demonstrate an ability to perform tests, collect data, and generate classifications irrespective of variations in testing locations and personnel.

  1. 5-8 study sites will be selected with each site being a recognized NIH Center of Excellence for Alzheimer's disease or other nationally recognized Alzheimer's disease research center.
  2. Each site will evaluate up to 60 subjects evenly divided between AD patients and age-matched controls (while the prevalence of AD is approximately 2% in the general population, the ratio of AD to normal among those who visit a clinic for memory or cognitive related issues is between 50-60%).
  3. Each site will follow the same testing protocols.
  4. All test data will be uploaded to the online COGNISION™ database server.
  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects between 60 and 90 years old meeting DSM-IV criteria for dementia of the Alzheimer's type and NINCDS-ADRDA criteria for probable AD will be recruited in the AD cohort. Matched cognitively healthy volunteers will be recruited for the Control group.

Criteria

Inclusion Criteria:

AD Cohort:

Subjects between 60 and 90 years old meeting NINCDS-ADRDA criteria for probable AD2 and DSM-IV criteria for dementia of the Alzheimer's type3 will be recruited in the AD cohort (MMSE ≥21, ≤26).

Memory complaint by subject and/or study partner SRP-1418 N Page: 8 of 26

Abnormal memory function score on Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (adjusted for education. Maximum score is 25):

i. < 10 for 16 or more years of education ii. < 6 for 8-15 years of education iii. < 4 for 0-7 years of education Clinical Dementia Rating (CDR) = 0.5, 1.0 or 2.0 Modified Hachinski Ischemic Scale (HIS) ≤ 4 Geriatric Depression Scale (GDS) < 6 For subjects that decide to provide a CSF sample: Platelet count ≥ 100,000/μL, Prothrombin Time (PT) = 11 to 16 seconds, International Normalized Ratio = 0.8 to 1.2 Study partner or caregiver to accompany subject to all scheduled visits Fluent in English Adequate visual acuity to allow neuropsychological testing Adequate auditory acuity to allow neuropsychological and ERP testing Good general health with no additional diseases expected to interfere with the study Willing to undergo neuroimaging and provide blood. The subject may optionally provide a CSF sample by lumbar puncture.

Normal Controls:

Healthy subjects matched for age, gender, and education level will be recruited as normal controls (MMSE ≥ 27).

Normal memory function will be documented by scoring at specific cutoffs on the

Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:

i. ≥ 10 for 16 or more years of education ii. ≥ 6 for 8-15 years of education iii. ≥ 4 for 0-7 years of education Study partner or caregiver Fluent in English Adequate visual acuity to allow neuropsychological testing Adequate auditory acuity to allow neuropsychological and ERP testing

Exclusion Criteria:

AD Cohort:

Severe or unstable forms of diabetes, heart disease, HIV, drug or alcohol abuse, etc. including severe AD: MMSE ≤20 Platelet count < 100,000/μL, Prothrombin Time (PT) > 16 seconds, International Normalized Ratio > 1.2 (for subjects that choose to provide a CSF sample by lumbar puncture).

Medical or psychiatric disorders that might complicate the assessment of dementia (i.e., mental retardation, alcohol abuse, drug abuse, HIV) A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, language difficulty) Recent intake of drugs known to cause major organ system toxicity or CNS alteration (e.g. sedation) Diseases of the dementia type other than AD (i.e., vascular dementia, frontotemporal dementia, Lewy Body Disease, Huntington's disease) Presence of non-MRI compatible implants/devices Prohibited Medications: Warfarin or other anticoagulants (for subjects that choose to provide a CSF sample by lumbar puncture), investigational agents.

Normal Controls:

Severe or unstable forms of diabetes, heart disease, HIV, drug or alcohol abuse, etc.

A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, language difficulty) Use of psychoactive drugs (only SSRI's are allowed) Psychiatric disorders (schizophrenia, bipolar, etc.) Depression (GDS > 6) Vascular dementia (HIS > 4) Other dementia (CDR > 0)

Abnormal memory function score on Wechsler Memory Scale -Logical Memory II subscale (delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25):

I. < 10 for 16 or more years of education II. < 6 for 8-15 years of education III. < 4 for 0-7 years of education

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938665

Locations
United States, Florida
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Healthcare
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston Center for Memory
Brookline, Massachusetts, United States, 02467
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
Neuronetrix, Inc.
Investigators
Principal Investigator: Charles D Smith, MD Univeristy of Kentucky
Principal Investigator: Murali Doraiswamy, MD Duke University
Principal Investigator: Steven E Arnold, MD University of Pennsylvania
Principal Investigator: Paul R Solomon, PhD The Memory Clinic, Bennington VT
Principal Investigator: Bradley S Folley, PhD Norton Healthcare, Louisville KY
Principal Investigator: Carl Sadowsky, MD Premiere Research Institute, West Palm Beach FL
Principal Investigator: Andrew E Budson, MD Boston Center for Memory
  More Information

No publications provided

Responsible Party: Neuronetrix, Inc.
ClinicalTrials.gov Identifier: NCT00938665     History of Changes
Other Study ID Numbers: SRP-1418
Study First Received: July 13, 2009
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Neuronetrix, Inc.:
Alzheimer
Memory disorder
dementia
cognitive behavioral decline
vascular dementia
front temporal dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Memory Disorders
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders

ClinicalTrials.gov processed this record on August 01, 2014