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NCT05673759
Event-Related Potential (ERP) Components in Clinical Diagnosis
Conditions: Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
Sex: All
Ages: 20 Years – 90 Years
Healthy volunteers: 1
Enrollment: 200
Sponsor: Boston University
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:For Mild Alzheimer Disease (AD) dementiaMeets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria50-90 years oldMini-Mental State Examination (MMSE) 20-27Performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and educationPerformance 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 diagnosesFor Mild cognitive impairment (MCI)MCI due to any etiology 50-90 years oldMMSE > 23Performance on delayed recall and recognition memory worse than 1.0 SD for age & education adjusted normsDr. Turk and Dr. Budson will confirm all MCI diagnosesFor Healthy older adults50-90 years oldFunctioning normally in occupation determined by self-reportFor Healthy younger adults20-50 years oldFunctioning normally in occupation determined by self-reportExclusion Criteria:A clinically significant problem of any of the following conditions:depressionheavy alcohol or drug usecerebrovascular diseasea 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 medicationUnable to understand the consent form
Source: ClinicalTrials.gov (NCT05673759). StuddyBuddy aggregates publicly available trial information.