Alzheimer Disease Clinical Trial
Official title:
The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
NCT number | NCT05673759 |
Other study ID # | H-43360 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 6, 2023 |
Est. completion date | December 2024 |
Verified date | March 2024 |
Source | Boston University |
Contact | Katherine Turk, MD |
Phone | (617) 638-7730 |
kturk[@]bu.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | BU Alzheimer Disease Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University | VoxNeuro Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electroencephalogram (EEG) memory diagnosis | The EEG memory diagnosis will be arrived through the blinded review of the EEG data | baseline | |
Secondary | The Montreal Cognitive Assessment (MoCA) performance | This neuropsychological test will be used for cognitive screening. The scores on this test ranges from 0 to 30, and lower scores indicate decreased cognitive ability. | baseline | |
Secondary | Mini Mental State Examination (MMSE) | This neuropsychological test will be used to assess cognitive functioning. MMSE scores range from 0 to 30 with lower scores indicating decreased cognitive ability. | baseline | |
Secondary | Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD) | The CERAD evaluates the immediate recall of a list of words (up to 30 correct recall on 3 individual recall trials), delayed recall (up to 10 correct recall after a 5 minute delay), and on yes-no recognition memory (up to 10 correct recognition) | baseline | |
Secondary | Verbal Fluency test: Phonemic Test and the Category Fluency test | Phonemic word fluency and categoric word fluency will be assessed using the Verbal Fluency: Phonemic Test and the Category Fluency test. For letter fluency, individuals name as many words as possible in one minute that start with the letters F, A, and S. For category fluency, individuals name as many words as possible in one minute that are within the Animals, Vegetables, and Fruits categories. | baseline | |
Secondary | Trails Making Test A and B | The Trail Making Test Part A consists of connecting a series a numbers with a line in ascending order as quickly as possible (performance is timed, and the score is the time to complete the task). The Trail Making Test Part B consists of connecting a series of letters and numbers, alternating back and forth between them, as quickly as possible in ascending order (performance is timed, and the score is the time to complete).This test will be used to assess the central executive functioning. | baseline | |
Secondary | Boston Naming Test | This test consists of 15 line drawings, with a maximum score of 15 correct. It will be used to assess naming skills in speakers of multiple languages | baseline | |
Secondary | EEG amplitude | EEG amplitudes will be measured from the EEG data | baseline | |
Secondary | EEG latency | EEG latency will be measured from the EEG data | baseline |
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