DementiaNCT02273921
EEG Classification System for Dementia
A study testing EEG recording in people with Dementia, run by Mentis Cura.
Trial summary
The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- EEG recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jun 2020
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of participant in the range of 50-90 years
Who cannot join
- Outside required age range
About this study
The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups.
In the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. The categorization is performed during the data analysis.
Read more
The groups in the data analysis will initially be based on the following:
- Healthy controls
- Mild Cognitive Impairment
- Alzheimers Disease (AD)
- Lewy-body Dementia
- Parkinsons Disease Dementia
- Vascular Dementia (VaD)
- Frontotemporal Dementia (FTD)
- Depression
Other groups will be added if needed.
- Conditions
- Dementia
- Being tested
- EEG recording
- Keywords
- Dementia, Diagnosis, Electroencephalography
- Medical subject headings
- Dementia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG recordingOther
EEG is recorded once for each participant
| Study group | Role | What they receive |
|---|---|---|
| EEG | No intervention | A non-invasive EEG recording Receives: Other: EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification system for dementia based on EEG
The EEGs recorded in the trial will be categorized into controls or predefined clinical groups based on the participants' clinical diagnosis. The classification system will be constructed using this categorization.
Measured: The quality of the classification system will be evaluated regularly, at least every 6 months, up to 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startMar 2005
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mentis Cura
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Responsible party
- Sponsor
- Investigators
- Jón Snædal, MD, Principal investigator, Landspitali University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273921
- Sponsor's protocol ID
- MC-CT-002
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Snaedal J, Johannesson GH, Gudmundsson TE, Gudmundsson S, Pajdak TH, Johnsen K. The use of EEG in Alzheimer's disease, with and without scopolamine - a pilot study. Clin Neurophysiol. 2010 Jun;121(6):836-41. doi: 10.1016/j.clinph.2010.01.008. Epub 2010 Feb 12.
PubMed 20153691Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
PubMed 17765604Snaedal J, Johannesson GH, Gudmundsson TE, Blin NP, Emilsdottir AL, Einarsson B, Johnsen K. Diagnostic accuracy of statistical pattern recognition of electroencephalogram registration in evaluation of cognitive impairment and dementia. Dement Geriatr Cogn Disord. 2012;34(1):51-60. doi: 10.1159/000339996. Epub 2012 Aug 23.
PubMed 22922592
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Classification System for Dementia
- ClinicalTrials.gov ID
- NCT02273921
- Acronym / sponsor ID
- MC-CT-002
- Conditions
- Dementia
- Keywords
- Dementia, Diagnosis, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Mentis CuraIndustry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Study start
- Mar 2005
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 24 Oct 2014 (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.
The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups.
In the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. The categorization is performed during the data analysis.
The groups in the data analysis will initially be based on the following:
- Healthy controls
- Mild Cognitive Impairment
- Alzheimers Disease (AD)
- Lewy-body Dementia
- Parkinsons Disease Dementia
- Vascular Dementia (VaD)
- Frontotemporal Dementia (FTD)
- Depression
Other groups will be added if needed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG | No intervention | Other: EEG recordingA non-invasive EEG recording |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age of participant in the range of 50-90 years
Key exclusion criteria (1 listed)
- Outside required age range
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 |
|---|---|---|
| EEG recordingEEG is recorded once for each participant | Other | EEG |
Primary outcome
Classification system for dementia based on EEG
Time frame: The quality of the classification system will be evaluated regularly, at least every 6 months, up to 6 years.
The EEGs recorded in the trial will be categorized into controls or predefined clinical groups based on the participants' clinical diagnosis. The classification system will be constructed using this categorization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Background: PubMed 20153691Snaedal J, Johannesson GH, Gudmundsson TE, Gudmundsson S, Pajdak TH, Johnsen K. The use of EEG in Alzheimer's disease, with and without scopolamine - a pilot study. Clin Neurophysiol. 2010 Jun;121(6):836-41. doi: 10.1016/j.clinph.2010.01.008. Epub 2010 Feb 12.
- Background: PubMed 17765604Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
- Results publication: PubMed 22922592Snaedal J, Johannesson GH, Gudmundsson TE, Blin NP, Emilsdottir AL, Einarsson B, Johnsen K. Diagnostic accuracy of statistical pattern recognition of electroencephalogram registration in evaluation of cognitive impairment and dementia. Dement Geriatr Cogn Disord. 2012;34(1):51-60. doi: 10.1159/000339996. Epub 2012 Aug 23.
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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.
Jón Snædal, MD principal investigator
Landspitali University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing EEG recording in people with Dementia, run by Mentis Cura.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Classification system for dementia based on EEG (time frame: The quality of the classification system will be evaluated regularly, at least every 6 months, up to 6 years.). 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 NCT02273921, which also lists 3 linked publications.
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 24 Oct 2014.