Event-Related Potential (ERP) Components in Clinical Diagnosis

Alzheimer Disease Clinical Trial

Official title:

The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673759
• Other study ID #: H-43360
• Status: Recruiting
• Start date: March 6, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Boston University
• Contact: Katherine Turk, MD
• Phone: (617) 638-7730
• Email: kturk[@]bu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia, Mild
• Mild Cognitive Impairment

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
United States	BU Alzheimer Disease Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	VoxNeuro Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalogram (EEG) memory diagnosis	The EEG memory diagnosis will be arrived through the blinded review of the EEG data	baseline
Secondary	The Montreal Cognitive Assessment (MoCA) performance	This neuropsychological test will be used for cognitive screening. The scores on this test ranges from 0 to 30, and lower scores indicate decreased cognitive ability.	baseline
Secondary	Mini Mental State Examination (MMSE)	This neuropsychological test will be used to assess cognitive functioning. MMSE scores range from 0 to 30 with lower scores indicating decreased cognitive ability.	baseline
Secondary	Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD)	The CERAD evaluates the immediate recall of a list of words (up to 30 correct recall on 3 individual recall trials), delayed recall (up to 10 correct recall after a 5 minute delay), and on yes-no recognition memory (up to 10 correct recognition)	baseline
Secondary	Verbal Fluency test: Phonemic Test and the Category Fluency test	Phonemic word fluency and categoric word fluency will be assessed using the Verbal Fluency: Phonemic Test and the Category Fluency test. For letter fluency, individuals name as many words as possible in one minute that start with the letters F, A, and S. For category fluency, individuals name as many words as possible in one minute that are within the Animals, Vegetables, and Fruits categories.	baseline
Secondary	Trails Making Test A and B	The Trail Making Test Part A consists of connecting a series a numbers with a line in ascending order as quickly as possible (performance is timed, and the score is the time to complete the task). The Trail Making Test Part B consists of connecting a series of letters and numbers, alternating back and forth between them, as quickly as possible in ascending order (performance is timed, and the score is the time to complete).This test will be used to assess the central executive functioning.	baseline
Secondary	Boston Naming Test	This test consists of 15 line drawings, with a maximum score of 15 correct. It will be used to assess naming skills in speakers of multiple languages	baseline
Secondary	EEG amplitude	EEG amplitudes will be measured from the EEG data	baseline
Secondary	EEG latency	EEG latency will be measured from the EEG data	baseline