Alzheimer DiseaseNCT05673759
Event-Related Potential (ERP) Components in Clinical Diagnosis
An observational study of Alzheimer Disease and Dementia, Mild, run by Boston University at 1 site in United States.
Trial summary
In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- What is being tested?
- Electroencephalogram (EEG) system, Standard Neuropsychological Testing and Additional neuropsychological tests
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 1 May 2025
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any participant age: 20-90 years old, with or without a diagnosis of AD or cognitive impairment.
Who may be able to join
- For Mild Alzheimer Disease (AD) dementia
- Meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
- 50-90 years old
- Mini-Mental State Examination (MMSE) 20-27
- Performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and education
- Performance on delayed recall and recognition memory worse than 1.5 SD for age \& education in at least one other cognitive domain (e.g., language, executive functioning) based on other tests in our neuropsychological test battery.
Show all 18Show fewer
- Dr. Turk and Dr. Budson will confirm all mild AD dementia diagnoses
- For Mild cognitive impairment (MCI)
- MCI due to any etiology 50-90 years old
- MMSE > 23
- Performance on delayed recall and recognition memory worse than 1.0 SD for age \& education adjusted norms
- Dr. Turk and Dr. Budson will confirm all MCI diagnoses
- For Healthy older adults
- 50-90 years old
- Functioning normally in occupation determined by self-report
- For Healthy younger adults
- 20-50 years old
- Functioning normally in occupation determined by self-report
Who cannot join
- A clinically significant problem of any of the following conditions:
- depression
- heavy alcohol or drug use
- cerebrovascular disease
- a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease)
- any medical condition whose severity could significantly impair cognition (e.g., organ failure)
- on any antipsychotic or epilepsy medication
- Unable to understand the consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
BU Alzheimer Disease Center
Boston, Massachusetts, 02118
About this study
Official title: The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission.
The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.
Read the detailed description
A cross sectional cohort study design with four groups will be implemented to determine how ERPs can provide diagnostic information and alter clinical management beyond that of neuropsychological testing alone in patients with Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI).
Secondary Objectives:
- To determine the impact of ERP testing (using cognitive health assessment reports) on change in research grade clinical diagnosis
- To determine the degree of correlation between quantitative ERP measures with neuropsychological testing performance using a standardized neuropsychological battery. 75 mild AD dementia and 75 MCI due to any etiology, 25 Older Adults (OA) and 25 Younger Adults (YA) will be enrolled over the course of two years. Each subject will participate in the study for 1 visit.
The in person 50-60-minute testing session consists of a neuropsychological battery, and an EEG session with computer tasks including the Auditory Oddball paradigm, a Continuous Visual Memory Test, Auditory Evoked Potentials, Visual Evoked Potentials, the Erikson Flanker Task, and the Hayling Task.
- Conditions
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- Being tested
- Electroencephalogram (EEG) system, Standard Neuropsychological Testing, Additional neuropsychological tests
- Keywords
- Memory Strategies, EEG headgear, Event-Related Potentials
- Medical subject headings
- Alzheimer Disease, Dementia, Lymphoma, Follicular, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram (EEG) systemDevice
Also called g.Nautilus PRO (G-Tec ™)
An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
Standard Neuropsychological TestingBehavioural
Also called Neuropsychological Battery
Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
Additional neuropsychological testsBehavioural
Younger participants will receive additional testing along with the standard neuropsychological battery including Pittsburgh Sleep Quality Index (PSQI) [37] for sleep quality measures, the Test of Memory Malingering (TOMM) for effort measure, Ohio State Traumatic Brain Injury Identification Method questionnaire (OSU-TBI) [38] to gather lifetime TBI history, and the Neurobehavioral Symptom Inventory (NBSI) [39] for post-concussive symptoms. These additional tests will add an extra fifteen minutes, making the total time for neuropsychological questionnaires 1 hour in younger participants.
| Study group | Role | What they receive |
|---|---|---|
| 75 Mild AD | 75 patients diagnosed with Mild Alzheimer's disease. Receives: Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing | |
| 75 MCI due to any etiology | 75 patients diagnosed with Mild Cognitive Impairment due to any etiology. Receives: Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing | |
| 25 Healthy Older Adults | 25 Healthy older adults age: 50-90 (control). Receives: Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing | |
| 25 Healthy Younger Adults | 25 Healthy younger adults age: 20-50 (control). Receives: Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing; Behavioral: Additional neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram (EEG) memory diagnosis
The EEG memory diagnosis will be arrived through the blinded review of the EEG data
Measured: baseline
Secondary outcomes (8)
The Montreal Cognitive Assessment (MoCA) performance
This neuropsychological test will be used for cognitive screening. The scores on this test ranges from 0 to 30, and lower scores indicate decreased cognitive ability.
Measured: baseline
Mini Mental State Examination (MMSE)
This neuropsychological test will be used to assess cognitive functioning. MMSE scores range from 0 to 30 with lower scores indicating decreased cognitive ability.
Measured: baseline
Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD)
The CERAD evaluates the immediate recall of a list of words (up to 30 correct recall on 3 individual recall trials), delayed recall (up to 10 correct recall after a 5 minute delay), and on yes-no recognition memory (up to 10 correct recognition)
Measured: baseline
Verbal Fluency test: Phonemic Test and the Category Fluency test
Phonemic word fluency and categoric word fluency will be assessed using the Verbal Fluency: Phonemic Test and the Category Fluency test. For letter fluency, individuals name as many words as possible in one minute that start with the letters F, A, and S. For category fluency, individuals name as many words as possible in one minute that are within the Animals, Vegetables, and Fruits categories.
Measured: baseline
Trails Making Test A and B
The Trail Making Test Part A consists of connecting a series a numbers with a line in ascending order as quickly as possible (performance is timed, and the score is the time to complete the task). The Trail Making Test Part B consists of connecting a series of letters and numbers, alternating back and forth between them, as quickly as possible in ascending order (performance is timed, and the score is the time to complete).This test will be used to assess the central executive functioning.
Measured: baseline
Boston Naming Test
This test consists of 15 line drawings, with a maximum score of 15 correct. It will be used to assess naming skills in speakers of multiple languages
Measured: baseline
EEG amplitude
EEG amplitudes will be measured from the EEG data
Measured: baseline
EEG latency
EEG latency will be measured from the EEG data
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start6 Mar 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: The sponsor stopped funding the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- VoxNeuro Inc.
- Responsible party
- Sponsor
- Investigators
- Katherine Turk, MD, Principal investigator, BU Chobanian & Avedisian School of MedicineAndrew Budson, MD, Principal investigator, BU Chobanian & Avedisian School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673759
- Sponsor's protocol ID
- H-43360
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2022
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05673759
- Acronym / sponsor ID
- H-43360
- Conditions
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- Keywords
- Memory Strategies, EEG headgear, Event-Related Potentials
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor stopped funding the study.
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- VoxNeuro Inc.
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 6 Jan 2023 (actual)
- 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.
In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission.
The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.
Detailed description
A cross sectional cohort study design with four groups will be implemented to determine how ERPs can provide diagnostic information and alter clinical management beyond that of neuropsychological testing alone in patients with Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI).
Secondary Objectives:
- To determine the impact of ERP testing (using cognitive health assessment reports) on change in research grade clinical diagnosis
- To determine the degree of correlation between quantitative ERP measures with neuropsychological testing performance using a standardized neuropsychological battery. 75 mild AD dementia and 75 MCI due to any etiology, 25 Older Adults (OA) and 25 Younger Adults (YA) will be enrolled over the course of two years. Each subject will participate in the study for 1 visit.
The in person 50-60-minute testing session consists of a neuropsychological battery, and an EEG session with computer tasks including the Auditory Oddball paradigm, a Continuous Visual Memory Test, Auditory Evoked Potentials, Visual Evoked Potentials, the Erikson Flanker Task, and the Hayling Task.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 75 Mild AD | – | Device: Electroencephalogram (EEG) system, Behavioral: Standard Neuropsychological Testing75 patients diagnosed with Mild Alzheimer's disease. |
| 75 MCI due to any etiology | – | Device: Electroencephalogram (EEG) system, Behavioral: Standard Neuropsychological Testing75 patients diagnosed with Mild Cognitive Impairment due to any etiology. |
| 25 Healthy Older Adults | – | Device: Electroencephalogram (EEG) system, Behavioral: Standard Neuropsychological Testing25 Healthy older adults age: 50-90 (control). |
| 25 Healthy Younger Adults | – | Device: Electroencephalogram (EEG) system, Behavioral: Standard Neuropsychological Testing, Behavioral: Additional neuropsychological tests25 Healthy younger adults age: 20-50 (control). |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any participant age: 20-90 years old, with or without a diagnosis of AD or cognitive impairment.
Key inclusion criteria (18 listed)
- For Mild Alzheimer Disease (AD) dementia
- Meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
- 50-90 years old
- Mini-Mental State Examination (MMSE) 20-27
- Performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and education
Key exclusion criteria (8 listed)
- depression
- heavy alcohol or drug use
- cerebrovascular disease
- a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease)
- any medical condition whose severity could significantly impair cognition (e.g., organ failure)
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 |
|---|---|---|
| Electroencephalogram (EEG) systemAlso: g.Nautilus PRO (G-Tec ™)An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use. | Device | 25 Healthy Older Adults, 25 Healthy Younger Adults, 75 MCI due to any etiology, 75 Mild AD |
| Standard Neuropsychological TestingAlso: Neuropsychological BatteryPrior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart. | Behavioural | 25 Healthy Older Adults, 25 Healthy Younger Adults, 75 MCI due to any etiology, 75 Mild AD |
| Additional neuropsychological testsYounger participants will receive additional testing along with the standard neuropsychological battery including Pittsburgh Sleep Quality Index (PSQI) [37] for sleep quality measures, the Test of Memory Malingering (TOMM) for effort measure, Ohio State Traumatic Brain Injury Identification Method questionnaire (OSU-TBI) [38] to gather lifetime TBI history, and the Neurobehavioral Symptom Inventory (NBSI) [39] for post-concussive symptoms. These additional tests will add an extra fifteen minutes, making the total time for neuropsychological questionnaires 1 hour in younger participants. | Behavioural | 25 Healthy Younger Adults |
Primary outcome
Electroencephalogram (EEG) memory diagnosis
Time frame: baseline
The EEG memory diagnosis will be arrived through the blinded review of the EEG data
8 secondary outcomes
The Montreal Cognitive Assessment (MoCA) performance
Time frame: baseline
Mini Mental State Examination (MMSE)
Time frame: baseline
Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD)
Time frame: baseline
Verbal Fluency test: Phonemic Test and the Category Fluency test
Time frame: baseline
Trails Making Test A and B
Time frame: baseline
Boston Naming Test
Time frame: baseline
EEG amplitude
Time frame: baseline
EEG latency
Time frame: baseline
Results and safety
The study was stopped early (reason given: The sponsor stopped funding the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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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
BU Chobanian & Avedisian School of Medicine
Andrew Budson, MD principal investigator
BU Chobanian & Avedisian School of Medicine
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 Alzheimer Disease and Dementia, Mild, run by Boston University 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?
The sponsor lists 18 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 16 Dec 2025. 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?
The study was stopped early (reason given: The sponsor stopped funding the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram (EEG) memory diagnosis (time frame: baseline). 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 16 Dec 2025.