Event-Related Potential (ERP) Components in Clinical Diagnosis
Key facts
- Who runs it
- Boston University
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 148 people enrolled
- Started
- 6 Mar 2023
- Ended
- 1 May 2025
- Type of study
- Observational, 4 groups
- Treatments tested
- Electroencephalogram (EEG) system
- Standard Neuropsychological Testing
- Additional neuropsychological tests
- Record updated
- 16 December 2025
- Why it stopped
- The sponsor stopped funding the study.
Who can take part
- Age
- 20 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- heavy alcohol or drug use
- A clinically significant problem of any of the following conditions:
- 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
- depression
- Unable to understand the consent form
Where in United States
- BU Alzheimer Disease CenterBoston, United States
About the trial
What the trial wants to find out
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.
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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.
The 4 groups in the trial
- 75 Mild AD
75 patients diagnosed with Mild Alzheimer's disease.
Treatment: Electroencephalogram (EEG) system and Standard Neuropsychological Testing
- 75 MCI due to any etiology
75 patients diagnosed with Mild Cognitive Impairment due to any etiology.
Treatment: Electroencephalogram (EEG) system and Standard Neuropsychological Testing
- 25 Healthy Older Adults
25 Healthy older adults age: 50-90 (control).
Treatment: Electroencephalogram (EEG) system and Standard Neuropsychological Testing
- 25 Healthy Younger Adults
25 Healthy younger adults age: 20-50 (control).
Treatment: Electroencephalogram (EEG) system, Standard Neuropsychological Testing, and Additional neuropsychological tests
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
- Record updated
- 16 December 2025