Mild Cognitive ImpairmentNCT02957227
Diagnosis of Alzheimer's Disease Using Event Related Potentials
An observational study of Mild Cognitive Impairment, run by VA Boston Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Mild Cognitive Impairment
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare
Jamaica Plain, Massachusetts, 02130
Katherine Turk, 857-364-2139, kturk@bu.edu
About this study
This study evaluates the use of an EEG device using Event Related Potentials to help diagnose Alzheimer's Disease in the outpatient clinical setting.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- No intervention is part of this study but patients use an EEG device during observational data collection.
- Keywords
- Alzheimer's disease, Frontotemporal Dementia, Lewy Body Dementia, Diagnosis
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Frontotemporal Dementia, Lewy Body Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is part of this study but patients use an EEG device during observational data collection.Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | cohort 1: Older adults with memory impairment Receives: 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 Receives: Device: No intervention is part of this study but patients use an EEG device during observational data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in memory disorder diagnosis
The memory diagnosis will be compared between a purely clinical diagnosis and the diagnosis arrived at through use of the EEG data.
Measured: 3 years
Secondary outcomes (5)
EEG peak amplitude and latency
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
Measured: 3 years
Cortical, quantitative MRI volume measurements
MRI volumes will be assessed using quantitative MRI software to assess whether they correlate with EEG amplitude and latency data
Measured: 3 years
Amyloid PET tracer uptake, Standardardized Uptake Value ratios (SUVRs)
Amyloid PET SUVR data will be compared to other outcome measures including EEG results and quantitative MRI as well as final clinical diagnosis.
Measured: 3 years
Mini mental status exam scores
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.
Measured: 3 years
Test of Memory and Malingering (TOMM) scores
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Katherine Turk, VA Boston Healthcare System
- Investigators
- Katherine Turk, MD, Principal investigator, VA, BU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957227
- Sponsor's protocol ID
- 5I01CX000736-02-COG
- Other IDs
- 5I01CX000736-02
- Status last verified
- Sep 2022
- First submitted
- 29 Jul 2016
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with other investigators upon written request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Alzheimer's Disease Using Event Related Potentials
- ClinicalTrials.gov ID
- NCT02957227
- Acronym / sponsor ID
- 5I01CX000736-02-COG
- Conditions
- Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Frontotemporal Dementia, Lewy Body Dementia, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Study start
- Jul 2016
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of an EEG device using Event Related Potentials to help diagnose Alzheimer's Disease in the outpatient clinical setting.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: No intervention is part of this study but patients use an EEG device during observational data collection.cohort 1: Older adults with memory impairment |
| 2 | – | Device: No intervention is part of this study but patients use an EEG device during observational data collection.cohort 2: Age matched healthy controls |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is part of this study but patients use an EEG device during observational data collection. | Device | 1, 2 |
Primary outcome
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.
5 secondary outcomes
EEG peak amplitude and latency
Time frame: 3 years
Cortical, quantitative MRI volume measurements
Time frame: 3 years
Amyloid PET tracer uptake, Standardardized Uptake Value ratios (SUVRs)
Time frame: 3 years
Mini mental status exam scores
Time frame: 3 years
Test of Memory and Malingering (TOMM) scores
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators upon written request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Turk, MD principal investigator
VA, BU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by VA Boston Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Turk, MD (847-364-2139, kturk@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in memory disorder diagnosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.