Clinical trial · Observational
Event-Related Potential (ERP) Components in Clinical Diagnosis
The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor stopped funding the study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional neuropsychological tests | Behavioral | — | UNRESOLVED |
| Electroencephalogram (EEG) system | Device | — | UNRESOLVED |
| Standard Neuropsychological Testing | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- 75 Mild AD
- description
- 75 patients diagnosed with Mild Alzheimer's disease.
- interventionNames
- Device: Electroencephalogram (EEG) system
- Behavioral: Standard Neuropsychological Testing
- label
- 75 MCI due to any etiology
- description
- 75 patients diagnosed with Mild Cognitive Impairment due to any etiology.
- interventionNames
- Device: Electroencephalogram (EEG) system
- Behavioral: Standard Neuropsychological Testing
- label
- 25 Healthy Older Adults
- description
- 25 Healthy older adults age: 50-90 (control).
- interventionNames
- Device: Electroencephalogram (EEG) system
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available