Clinical trial NCT05673759: Event-Related Potential (ERP) Components in Clinical Diagnosis
Official title: The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Alzheimer Disease
Dementia, Mild
Mild Cognitive Impairment
Keywords: Memory Strategies
EEG headgear
Event-Related Potentials
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: VoxNeuro Inc.
First posted: 2023-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Any participant age: 20-90 years old, with or without a diagnosis of AD or cognitive impairment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Electroencephalogram (EEG) memory diagnosis
timeFrame: baseline
Secondary outcomes:
measure: The Montreal Cognitive Assessment (MoCA) performance
timeFrame: baseline
measure: Mini Mental State Examination (MMSE)
timeFrame: baseline
measure: Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD)
timeFrame: baseline
measure: Verbal Fluency test: Phonemic Test and the Category Fluency test
timeFrame: baseline
measure: Trails Making Test A and B
timeFrame: baseline
measure: Boston Naming Test
timeFrame: baseline
measure: EEG amplitude
timeFrame: baseline
measure: EEG latency
timeFrame: baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: BU Alzheimer Disease Center
state: Massachusetts
Study officials:
affiliation: BU Chobanian & Avedisian School of Medicine
name: Katherine Turk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BU Chobanian & Avedisian School of Medicine
name: Andrew Budson, MD
role: PRINCIPAL_INVESTIGATOR
References: