- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957227
Diagnosis of Alzheimer's Disease Using Event Related Potentials
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Katherine Turk, MD
- Phone Number: 847-364-2139
- Email: kturk@bu.edu
Study Locations
-
-
Massachusetts
-
Jamaica Plain, Massachusetts, United States, 02130
- Recruiting
- VA Boston Healthcare
-
Contact:
- Katherine Turk
- Phone Number: 857-364-2139
- Email: kturk@bu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
cohort 1: Older adults with memory impairment
|
|
2
cohort 2: Age matched healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
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 years
|
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.
|
3 years
|
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.
|
3 years
|
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.
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine Turk, MD, VA, BU
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5I01CX000736-02-COG
- 5I01CX000736-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Centre for Addiction and Mental HealthRecruitingAmnestic Mild Cognitive ImpairmentCanada
-
University of FloridaNational Institute on Aging (NIA)RecruitingAmnestic Mild Cognitive ImpairmentUnited States
-
Charite University, Berlin, GermanyCompletedMild Cognitive Impairment (MCI)Germany
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
Clinical Trials on No intervention is part of this study but patients use an EEG device during observational data collection.
-
The University of Texas Health Science Center,...CompletedWound InfectionUnited States
-
VA Office of Research and DevelopmentVA Boston Healthcare SystemRecruitingMild Cognitive Impairment | Mild Traumatic Brain Injury | Moderate Traumatic Brain InjuryUnited States
-
Istituto Clinico HumanitasUnknown