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Purpose

In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission. The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.

Conditions

Eligibility

Eligible Ages
Between 20 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

For Mild Alzheimer Disease (AD) dementia - Meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria - 50-90 years old - Mini-Mental State Examination (MMSE) 20-27 - Performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and education - Performance on delayed recall and recognition memory worse than 1.5 SD for age & education in at least one other cognitive domain (e.g., language, executive functioning) based on other tests in our neuropsychological test battery. - Dr. Turk and Dr. Budson will confirm all mild AD dementia diagnoses For Mild cognitive impairment (MCI) - MCI due to any etiology 50-90 years old - MMSE > 23 - Performance on delayed recall and recognition memory worse than 1.0 SD for age & education adjusted norms - Dr. Turk and Dr. Budson will confirm all MCI diagnoses For Healthy older adults - 50-90 years old - Functioning normally in occupation determined by self-report For Healthy younger adults - 20-50 years old - Functioning normally in occupation determined by self-report

Exclusion Criteria

A clinically significant problem of any of the following conditions: - depression - heavy alcohol or drug use - cerebrovascular disease - a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease) - any medical condition whose severity could significantly impair cognition (e.g., organ failure) - on any antipsychotic or epilepsy medication - Unable to understand the consent form

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
75 Mild AD 75 patients diagnosed with Mild Alzheimer's disease.
  • Device: Electroencephalogram (EEG) system
    An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
    Other names:
    • g.Nautilus PRO (G-Tec ™)
  • Behavioral: Standard Neuropsychological Testing
    Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
    Other names:
    • Neuropsychological Battery
75 MCI due to any etiology 75 patients diagnosed with Mild Cognitive Impairment due to any etiology.
  • Device: Electroencephalogram (EEG) system
    An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
    Other names:
    • g.Nautilus PRO (G-Tec ™)
  • Behavioral: Standard Neuropsychological Testing
    Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
    Other names:
    • Neuropsychological Battery
25 Healthy Older Adults 25 Healthy older adults age: 50-90 (control).
  • Device: Electroencephalogram (EEG) system
    An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
    Other names:
    • g.Nautilus PRO (G-Tec ™)
  • Behavioral: Standard Neuropsychological Testing
    Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
    Other names:
    • Neuropsychological Battery
25 Healthy Younger Adults 25 Healthy younger adults age: 20-50 (control).
  • Device: Electroencephalogram (EEG) system
    An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
    Other names:
    • g.Nautilus PRO (G-Tec ™)
  • Behavioral: Standard Neuropsychological Testing
    Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
    Other names:
    • Neuropsychological Battery
  • Behavioral: Additional neuropsychological tests
    Younger participants will receive additional testing along with the standard neuropsychological battery including Pittsburgh Sleep Quality Index (PSQI) [37] for sleep quality measures, the Test of Memory Malingering (TOMM) for effort measure, Ohio State Traumatic Brain Injury Identification Method questionnaire (OSU-TBI) [38] to gather lifetime TBI history, and the Neurobehavioral Symptom Inventory (NBSI) [39] for post-concussive symptoms. These additional tests will add an extra fifteen minutes, making the total time for neuropsychological questionnaires 1 hour in younger participants.

Recruiting Locations

BU Alzheimer Disease Center
Boston, Massachusetts 02118
Contact:
Meltem Karaca, PhD
mkaraca@bu.edu

More Details

Status
Recruiting
Sponsor
Boston University

Study Contact

Katherine Turk, MD
(617) 638-7730
kturk@bu.edu

Detailed Description

A cross sectional cohort study design with four groups will be implemented to determine how ERPs can provide diagnostic information and alter clinical management beyond that of neuropsychological testing alone in patients with Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI). Secondary Objectives: - To determine the impact of ERP testing (using cognitive health assessment reports) on change in research grade clinical diagnosis - To determine the degree of correlation between quantitative ERP measures with neuropsychological testing performance using a standardized neuropsychological battery. 75 mild AD dementia and 75 MCI due to any etiology, 25 Older Adults (OA) and 25 Younger Adults (YA) will be enrolled over the course of two years. Each subject will participate in the study for 1 visit. The in person 50-60-minute testing session consists of a neuropsychological battery, and an EEG session with computer tasks including the Auditory Oddball paradigm, a Continuous Visual Memory Test, Auditory Evoked Potentials, Visual Evoked Potentials, the Erikson Flanker Task, and the Hayling Task.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.