Event-Related Potential (ERP) Components in Clinical Diagnosis

Suspended

• Conditions: Dementia, Mild; Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing; Behavioral: Additional neuropsychological tests

• Registration Number: NCT05673759
• Lead Sponsor: Boston University

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-30
• Study First Posted: 2023-01-06
• Study Start: 2023-03-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
75 Mild AD	Electroencephalogram (EEG) system	75 patients diagnosed with Mild Alzheimer's disease.
75 MCI due to any etiology	Standard Neuropsychological Testing	75 patients diagnosed with Mild Cognitive Impairment due to any etiology.
25 Healthy Older Adults	Electroencephalogram (EEG) system	25 Healthy older adults age: 50-90 (control).
25 Healthy Older Adults	Standard Neuropsychological Testing	25 Healthy older adults age: 50-90 (control).
25 Healthy Younger Adults	Additional neuropsychological tests	25 Healthy younger adults age: 20-50 (control).
25 Healthy Younger Adults	Electroencephalogram (EEG) system	25 Healthy younger adults age: 20-50 (control).
25 Healthy Younger Adults	Standard Neuropsychological Testing	25 Healthy younger adults age: 20-50 (control).
75 Mild AD	Standard Neuropsychological Testing	75 patients diagnosed with Mild Alzheimer's disease.
75 MCI due to any etiology	Electroencephalogram (EEG) system	75 patients diagnosed with Mild Cognitive Impairment due to any etiology.

Primary Outcome Measures

Name	Time	Method
Electroencephalogram (EEG) memory diagnosis	baseline	The EEG memory diagnosis will be arrived through the blinded review of the EEG data

Secondary Outcome Measures

Name	Time	Method
EEG amplitude	baseline	EEG amplitudes will be measured from the EEG data
Boston Naming Test	baseline	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
Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD)	baseline	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)
The Montreal Cognitive Assessment (MoCA) performance	baseline	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.
Verbal Fluency test: Phonemic Test and the Category Fluency test	baseline	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.
Mini Mental State Examination (MMSE)	baseline	This neuropsychological test will be used to assess cognitive functioning. MMSE scores range from 0 to 30 with lower scores indicating decreased cognitive ability.
EEG latency	baseline	EEG latency will be measured from the EEG data
Trails Making Test A and B	baseline	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.

Trial Locations

Locations (1)

BU Alzheimer Disease Center; 🇺🇸 Boston, Massachusetts, United States