Diagnosis of Alzheimer's Disease Using Event Related Potentials

Veterans Affairs (VA) Boston Healthcare System

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Device: No intervention is part of this study but patients use an EEG device during observational data collection.

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT02957227

5I01CX000736-02-COG

5I01CX000736-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study evaluates the use of an EEG device using Event Related Potentials to help diagnose Alzheimer's Disease in the outpatient clinical setting.

Full description

The objective of this study is to improve the accuracy of diagnosis of Alzheimer's disease in a clinic setting using an EEG device to measure event related potentials.

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Cohort 1: Older adults with memory impairment: must have a physician or primary caregiver report of memory loss and must be between 50 and 100 years old.

cohort 2: Older adults who test normally on neuropsychologic testing and have no history of neurologic disorders.

Exclusion Criteria: Lack of reported memory loss by physician or primary caregiver who does not meet age limits.

Trial design

170 participants in 2 patient groups

1

Description:

cohort 1: Older adults with memory impairment

Treatment:

Device: No intervention is part of this study but patients use an EEG device during observational data collection.

2

Description:

cohort 2: Age matched healthy controls

Treatment:

Device: No intervention is part of this study but patients use an EEG device during observational data collection.