Diagnosis of Alzheimer's Disease Using Event Related Potentials
NCT ID: NCT02957227
Last Updated: 2022-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
170 participants
OBSERVATIONAL
2016-07-31
2023-07-31
Brief Summary
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Detailed Description
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This study will recruit patients who are being seen with a memory complaint or the first time. It will be prospective in nature. Subjects will initially be evaluated by clinicians and then clinicians will fill out a rating questionnaire as to their level of certainty of various possible dementia diagnoses. Then, during the testing portion of the study, subjects will return to have an EEG test completed measuring event related potentials during an acoustic oddball paradigm task. The EEG will be completed by a technician who has no knowledge of the subject's clinical diagnosis. After the EEG is performed, the data will be evaluated by the study clinician in a blinded fashion. The clinician will log the EEG results as being either consistent with Alzheimer's disease or not. Finally, there will be analysis of the initial clinical rating by clinicians in comparison to a given subject's EEG results and interpretation. This will allow determination as to whether or not the clinical diagnosis was in agreement or disagreement with the EEG data and interpretation. At this time point a second clinician rating questionnaire will be completed to assess the current level of confidence and diagnostic certainty in light of the now revealed EEG data in addition to clinical data. There will also be quantitative analysis of MRI structural data regarding regional atrophy patterns as well as Amyloid PET data for some of the participants which will act as a diagnostic gold standard.
An additional aim of this study is to investigate patterns of impairment on memory testing in older adults who are malingering and reporting a memory impairment in the absence of a disorder. This aim will involve testing healthy older adults using EEG and also testing memory impaired older adults with AD and comparing the results, as well as comparing the two groups results on neuropsychologic measures of effort including the Test of Memory and Malingering (TOMM).
Impact/Significance: This proposed study could allow for increased accuracy and diagnostic certainty of the correct diagnosis among memory impaired patients and could allow for the incorporation of a new clinical technique, EEG testing among memory impaired patients.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
cohort 1: Older adults with memory impairment
No intervention is part of this study but patients use an EEG device during observational data collection.
2
cohort 2: Age matched healthy controls
No intervention is part of this study but patients use an EEG device during observational data collection.
Interventions
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No intervention is part of this study but patients use an EEG device during observational data collection.
Eligibility Criteria
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Inclusion Criteria
50 Years
100 Years
ALL
No
Sponsors
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VA Boston Healthcare System
FED
Responsible Party
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Katherine Turk
Neurologist
Principal Investigators
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Katherine Turk, MD
Role: PRINCIPAL_INVESTIGATOR
VA, BU
Locations
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VA Boston Healthcare
Jamaica Plain, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5I01CX000736-02-COG
Identifier Type: -
Identifier Source: org_study_id
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