Alzheimer's DiseaseNCT02769234
EEG/ERP Longitudinal Study in Alzheimer's Disease (AD)
An observational study of Alzheimer's Disease, run by Neuronetrix, Inc. at 3 sites in United States.
Trial summary
In a previous study, NCT00582127, two age-matched cohorts, one clinically diagnosed with mild Alzheimer's disease and the other healthy controls, were tested with a hand-held EEG/ERP system to determine if the cohorts could be discriminated using the EEG/ERP measures. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ERP/EEG test and Psychometric testing
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2016to Jul 2017
- 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AD subjects that successfully completed ERP/EEG testing during NCT00582127.
Who may be able to join
- Between 60 and 95 years old (inclusive) A diagnosis of Alzheimer's disease A successful ERP/EEG test performed with the COGNISION™ system 2-5 years prior to testing for the current study
- A sub-group of up to 40 subjects will be called back to the sites for follow-up ERP/qEEG and psychometric testing. Additional inclusion criteria for these subjects will be:
- Willing and able to undergo ERP/EEG and psychometric testing
- Have a study partner able to provide an independent evaluation of functioning
- Permitted medications stable for at least 2 weeks prior to testing
Who cannot join
- Subjects will not be called back to sites for follow-up testing if they have:
- Known allergy to latex
- Neuropsychological tests administered within three months of study enrollment
- Investigational agents administered within three months of study enrollment
- Severe cognitive and functional deficits that in the judgement of the site PI will prevent them from successfully completing ERP/EEG and/or psychometric testing
- Any significant systemic illness or unstable medical condition at the time of testing which could lead to difficulty complying with the protocol
- Use of psychoactive substances (Gingko Biloba, melatonin, sedatives etc.) will be allowed as long as the subject suspends their use on the day of testing. Smokers will not be required to abstain.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Memory Clinic
Bennington, Vermont, 05201
Boston Center for Memory
Brookline, Massachusetts, 02467
Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: ERP and qEEG Measures Collected in Outpatient Settings as Indices of Disease Progression in Alzheimer's Disease (AD)
In a previous study, NCT00582127, two age-matched cohorts, one clinically diagnosed with mild Alzheimer's disease and the other healthy controls, were tested with a hand-held EEG/ERP system to determine if the cohorts could be discriminated using the EEG/ERP measures. This study proposes to retest the AD cohort 18-60 months after their first test to characterize the change in EEG/ERP measures correlated with the longitudinal change in neuropsychological testing.
Read the detailed description
In study NCT00582127, two age-matched cohorts (mild AD, n=98 and healthy controls, n=100) were recruited to 7 clinical sites to undergo a broad range of clinical, neuropsychological, and neuroelectrophysiological tests. The complete battery of ADNI neuropsychological tests were performed on the mild AD subjects as well as standard blood tests and MRI using the ADNI protocol. MRI volumetry analysis was performed on the MRI data. Both cohorts underwent a 3-minute EEG recording and event-related potential (ERP) testing using a standard 2-deviant auditory oddball paradigm with the COGNISION(tm) System from Neuronetrix. The study showed that specific EEG/ERP features could be used to discriminate the mild AD cohort from healthy controls.
The current study is intended as a follow up to NCT00582127.AD subjects that successfully completed COGNISION™ and psychometric testing in the previous study are eligible to be part of the present follow up.
In the first part of the current study, de-identified cognitive and functional data for the AD patients that the sites have collected during regular check ups after testing for the original Neuronetrix study will be shared with the study Sponsor. The retrospective chart review has three main objectives:
- Quantify the rate of cognitive and functional decline in these patients.
- Investigate whether ERP and/or qEEG data collected during testing for the original Neuronetrix study can provide any insight on subsequent rate of cognitive and functional decline.
- Identify study subjects that might still be functional enough to successfully complete a follow-up ERP/qEEG test. These subjects will be offered an opportunity to come back to the sites for follow-up ERP/qEEG and psychometric testing.
Up to 40 subjects will be invited back to the sites. Subjects that choose to enroll in the second part of the study will have an ERP/qEEG test administered by a Neuronetrix certified test administrator. Subjects that complete the test successfully will move on to clinical evaluation and psychometric testing.
Results obtained from this part of the study will be compared with ERP/qEEG and psychometric data from the completed Neuronetrix study mentioned above. The two main objectives of the comparisons will be:
- Investigate whether ERP and qEEG measures collected in outpatient settings show significant changes over time in subjects with AD.
- Correlate longitudinal changes in ERP and qEEG measures (if any) with cognitive and functional decline as measured by psychometric tests.
- Conditions
- Alzheimer's Disease
- Being tested
- ERP/EEG test, Psychometric testing
- Keywords
- EEG, ERP, Event-related Potentials, Alzheimer's, P300
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERP/EEG testProcedure or surgery
The testing protocol consists of an auditory oddball ERP paradigm, followed by the collection of 3min of resting EEG. During the ERP paradigm a variety of auditory stimuli are played through the system's earphones while voltage potentials are recorded from the subject's scalp. At the end of the ERP session, 3 minutes of EEG data will be recorded while the subject is resting. The entire procedure, including set up, instructions to the subject and actual test is expected to take 45-60 minutes.
Psychometric testingProcedure or surgery
Subjects that complete ERP/qEEG testing successfully will move on to clinical and neuropsychological evaluation. Demographic information with also be collected.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease | Subjects with a diagnosis of Alzheimer's disease that successfully performed an ERP/EEG test with the COGNISION(TM) System prior to enrollment for the current study are eligible to participate. Receives: Procedure: ERP/EEG test; Procedure: Psychometric testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation (longitudinal change) between EEG/ERP vs. Neuropsychological Testing.
Measured: 24-60 Months
Secondary outcomes (2)
Correlation (longitudinal change) between EEG/ERP vs ADNI-EF composite.
Measured: 24-60 Months
Correlation (longitudinal change) between EEG/ERP vs. ADNI-Mem composite.
Measured: 24-60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Center for Memory, The Memory Clinic of Vermont, Premiere Research Institute
- Responsible party
- Sponsor
- Investigators
- Marco Cecchi, PhD, Study director, Neuronetrix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769234
- Sponsor's protocol ID
- SRP-1782
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2015
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cecchi M, Moore DK, Sadowsky CH, Solomon PR, Doraiswamy PM, Smith CD, Jicha GA, Budson AE, Arnold SE, Fadem KC. A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings. Alzheimers Dement (Amst). 2015 Oct 2;1(4):387-94. doi: 10.1016/j.dadm.2015.08.004. eCollection 2015 Dec.
PubMed 27239520
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERP and qEEG Measures Collected in Outpatient Settings as Indices of Disease Progression in Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT02769234
- Acronym / sponsor ID
- SRP-1782
- Conditions
- Alzheimer's Disease
- Keywords
- EEG, ERP, Event-related Potentials, Alzheimer's, P300
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Neuronetrix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boston Center for Memory, The Memory Clinic of Vermont, Premiere Research Institute
- Study start
- May 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 May 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.
In a previous study, NCT00582127, two age-matched cohorts, one clinically diagnosed with mild Alzheimer's disease and the other healthy controls, were tested with a hand-held EEG/ERP system to determine if the cohorts could be discriminated using the EEG/ERP measures. This study proposes to retest the AD cohort 18-60 months after their first test to characterize the change in EEG/ERP measures correlated with the longitudinal change in neuropsychological testing.
Detailed description
In study NCT00582127, two age-matched cohorts (mild AD, n=98 and healthy controls, n=100) were recruited to 7 clinical sites to undergo a broad range of clinical, neuropsychological, and neuroelectrophysiological tests. The complete battery of ADNI neuropsychological tests were performed on the mild AD subjects as well as standard blood tests and MRI using the ADNI protocol. MRI volumetry analysis was performed on the MRI data. Both cohorts underwent a 3-minute EEG recording and event-related potential (ERP) testing using a standard 2-deviant auditory oddball paradigm with the COGNISION(tm) System from Neuronetrix. The study showed that specific EEG/ERP features could be used to discriminate the mild AD cohort from healthy controls.
The current study is intended as a follow up to NCT00582127.AD subjects that successfully completed COGNISION™ and psychometric testing in the previous study are eligible to be part of the present follow up.
In the first part of the current study, de-identified cognitive and functional data for the AD patients that the sites have collected during regular check ups after testing for the original Neuronetrix study will be shared with the study Sponsor. The retrospective chart review has three main objectives:
- Quantify the rate of cognitive and functional decline in these patients.
- Investigate whether ERP and/or qEEG data collected during testing for the original Neuronetrix study can provide any insight on subsequent rate of cognitive and functional decline.
- Identify study subjects that might still be functional enough to successfully complete a follow-up ERP/qEEG test. These subjects will be offered an opportunity to come back to the sites for follow-up ERP/qEEG and psychometric testing.
Up to 40 subjects will be invited back to the sites. Subjects that choose to enroll in the second part of the study will have an ERP/qEEG test administered by a Neuronetrix certified test administrator. Subjects that complete the test successfully will move on to clinical evaluation and psychometric testing.
Results obtained from this part of the study will be compared with ERP/qEEG and psychometric data from the completed Neuronetrix study mentioned above. The two main objectives of the comparisons will be:
- Investigate whether ERP and qEEG measures collected in outpatient settings show significant changes over time in subjects with AD.
- Correlate longitudinal changes in ERP and qEEG measures (if any) with cognitive and functional decline as measured by psychometric tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease | – | Procedure: ERP/EEG test, Procedure: Psychometric testingSubjects with a diagnosis of Alzheimer's disease that successfully performed an ERP/EEG test with the COGNISION(TM) System prior to enrollment for the current study are eligible to participate. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AD subjects that successfully completed ERP/EEG testing during NCT00582127.
Key inclusion criteria (5 listed)
- Between 60 and 95 years old (inclusive) A diagnosis of Alzheimer's disease A successful ERP/EEG test performed with the COGNISION™ system 2-5 years prior to testing for the current study
- A sub-group of up to 40 subjects will be called back to the sites for follow-up ERP/qEEG and psychometric testing. Additional inclusion criteria for these subjects will be:
- Willing and able to undergo ERP/EEG and psychometric testing
- Have a study partner able to provide an independent evaluation of functioning
- Permitted medications stable for at least 2 weeks prior to testing
Key exclusion criteria (7 listed)
- Known allergy to latex
- Neuropsychological tests administered within three months of study enrollment
- Investigational agents administered within three months of study enrollment
- Severe cognitive and functional deficits that in the judgement of the site PI will prevent them from successfully completing ERP/EEG and/or psychometric testing
- Any significant systemic illness or unstable medical condition at the time of testing which could lead to difficulty complying with the protocol
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 |
|---|---|---|
| ERP/EEG testThe testing protocol consists of an auditory oddball ERP paradigm, followed by the collection of 3min of resting EEG. During the ERP paradigm a variety of auditory stimuli are played through the system's earphones while voltage potentials are recorded from the subject's scalp. At the end of the ERP session, 3 minutes of EEG data will be recorded while the subject is resting. The entire procedure, including set up, instructions to the subject and actual test is expected to take 45-60 minutes. | Procedure or surgery | Alzheimer's disease |
| Psychometric testingSubjects that complete ERP/qEEG testing successfully will move on to clinical and neuropsychological evaluation. Demographic information with also be collected. | Procedure or surgery | Alzheimer's disease |
Primary outcome
Correlation (longitudinal change) between EEG/ERP vs. Neuropsychological Testing.
Time frame: 24-60 Months
2 secondary outcomes
Correlation (longitudinal change) between EEG/ERP vs ADNI-EF composite.
Time frame: 24-60 Months
Correlation (longitudinal change) between EEG/ERP vs. ADNI-Mem composite.
Time frame: 24-60 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Background: PubMed 27239520Cecchi M, Moore DK, Sadowsky CH, Solomon PR, Doraiswamy PM, Smith CD, Jicha GA, Budson AE, Arnold SE, Fadem KC. A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings. Alzheimers Dement (Amst). 2015 Oct 2;1(4):387-94. doi: 10.1016/j.dadm.2015.08.004. eCollection 2015 Dec.
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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.
Marco Cecchi, PhD study director
Neuronetrix, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Neuronetrix, Inc. at 3 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation (longitudinal change) between EEG/ERP vs. Neuropsychological Testing. (time frame: 24-60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769234, which also lists 1 linked publication.
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 26 Feb 2020.