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Diagnosis of Alzheimer's Disease Using Event Related Potentials

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ClinicalTrials.gov Identifier: NCT02957227
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Katherine Turk, VA Boston Healthcare System

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

Condition or disease Intervention/treatment
Mild Cognitive Impairment Device: No intervention is part of this study but patients use an EEG device during observational data collection.

Detailed 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.


Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnosis of Alzheimer's Disease Using Event Related Potentials
Study Start Date : July 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Group/Cohort Intervention/treatment
1
cohort 1: Older adults with memory impairment
Device: No intervention is part of this study but patients use an EEG device during observational data collection.
2
cohort 2: Age matched healthy controls
Device: No intervention is part of this study but patients use an EEG device during observational data collection.



Primary Outcome Measures :
  1. Change in memory disorder diagnosis [ Time Frame: 3 years ]
    The memory diagnosis will be compared between a purely clinical diagnosis and the diagnosis arrived at through use of the EEG data.


Secondary Outcome Measures :
  1. EEG peak amplitude and latency [ Time Frame: 3 years ]
    Will be measured in order to answer the question of whether EEG amplitude and latency are predictive of Alzheimer's disease severity, using regression analysis

  2. Cortical, quantitative MRI volume measurements [ Time Frame: 3 years ]
    MRI volumes will be assessed using quantitative MRI software to assess whether they correlate with EEG amplitude and latency data

  3. Amyloid PET tracer uptake, Standardardized Uptake Value ratios (SUVRs) [ Time Frame: 3 years ]
    Amyloid PET SUVR data will be compared to other outcome measures including EEG results and quantitative MRI as well as final clinical diagnosis.

  4. Mini mental status exam scores [ Time Frame: 3 years ]
    Quantitative results from this neuropsychological test will be used to assess level of cognitive function in subjects and will be correlated with other outcome measures.

  5. Test of Memory and Malingering (TOMM) scores [ Time Frame: 3 years ]
    TOMM scores will be compared between healthy older adults simulating a memory impairment with older adults who have AD. Also both cohorts will undergo EEG testing in order to determine if EEG along with the TOMM helps determine whether older adults are displaying true cognitive impairment, or are malingering.



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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a memory disorder based on caregiver or referring clinician report who are being seen in the memory disorders clinic for the first time as well as age-matched older healthy controls without a neurologic condition.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957227


Contacts
Contact: Katherine Turk, MD 847-364-2139 kturk@bu.edu

Locations
United States, Massachusetts
VA Boston Healthcare Recruiting
Jamaica Plain, Massachusetts, United States, 02130
Contact: Katherine Turk    857-364-2139    kturk@bu.edu   
Sponsors and Collaborators
VA Boston Healthcare System
Investigators
Principal Investigator: Katherine Turk, MD VA, BU

Responsible Party: Katherine Turk, Neurologist, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT02957227     History of Changes
Other Study ID Numbers: 5I01CX000736-02-COG
5I01CX000736-02 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with other investigators upon written request.

Keywords provided by Katherine Turk, VA Boston Healthcare System:
Alzheimer's disease
Frontotemporal Dementia
Lewy Body Dementia
Diagnosis

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders