Event-Related Potential (ERP) Components in Clinical Diagnosis
Stopped: The sponsor stopped funding the study.
United States148 participantsStarted 2023-03-06
Plain-language 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.
Who can participate
Age range
20 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ep…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.