Mild Cognitive ImpairmentNCT03659643
Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker
An observational study of Mild Cognitive Impairment, run by Jon Snaedal at 1 site in Iceland.
Trial summary
Multi center study of six Memory Clinics in four Nordic countries in validating a prognostic diagnostic investigation of qEEG in Mild Cognitive Impairment (MCI). The study is in two parts, the first one is a follow up of a previous study conducted in 2011-2013 and the second half is new recruitment with two years… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- EEG with SPR analysis
- How many people
- 300 participants
- Where
- 1 siteIceland
- Study dates
- 1 Jan 2018to 1 Oct 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals referred for diagnostic evaluation to an academic Memory Clinic (MC) in either of the six participating centers. Group 1: Individuals diagnosed with either SCI or MCI in a study by the same centers in 2011-2013 Group 2: Individuals referred to the same academic MC, diagnosed with the cognitive status of MCI at the first visit. They are followed up for 2 years for evaluation of their cognitive status and if diagnosed with dementia, their disorder is registered.
Who may be able to join
- Group 1: Individuals diagnosed with either SCI or MCI during 2011-2013 Group 2: Individuals diagnosed with MCI at entry of the study
- -
Who cannot join
- Age <50 years or >85 years
- Medically or psychologically unstable
- Living outside the capital region
Trial locations and contacts
1 site in 1 country.
Iceland1 site, 1 recruiting
- Recruiting
Landspitali University Hospital
Reykjavik
Jon Snaedal, MD, 8640478 ext. 354, jsnaedal@landspitali.is
About this study
Multi center study of six Memory Clinics in four Nordic countries in validating a prognostic diagnostic investigation of qEEG in Mild Cognitive Impairment (MCI). The study is in two parts, the first one is a follow up of a previous study conducted in 2011-2013 and the second half is new recruitment with two years follow up. End points are diagnosis of a dementing disorder, primarily dementia of Alzheimer´s type.
Read the detailed description
The Nordic Network in Dementia Diagnostics (NIDD) conducted a study in 2011-2013 on qEEG using a method of Statistical Pattern Recognition (SPR) in six academic Memory Clinics in four Nordic countries. In the current study, those from the former study diagnosed either with Mild Cognitive Impairment (MCI; n= 120) or with Subjective Cognitive Impairment (SCI; n=60) are contacted again and evaluated for cognitive impairment. The EEG registered at entry in the former study is considered in relation to their current diagnosis (SCI,MCI or dementia) and thereby, the prognostic value of the method is evaluated.
In the second part of the study (n=120), new patients evaluated in the Memory Clinics and diagnosed with MCI (not SCI) are invited to participate for a two year follow up.
In the diagnostic work-up, simple screening tests and information from a close relative form the basis of the cognitive status (SCI;MCI, Dementia). In evaluating the cause of cognitive impairment, detailed neuropsychological testing is performed as well as MRI of the brain and CSF for Alzheimer´s markers. qEEG with SPR analysis is registered but the clinician is blinded to its outcome.
The end point in both parts of the study is a diagnosis of a dementing disorder.
- Conditions
- Mild Cognitive Impairment
- Being tested
- EEG with SPR analysis
- Keywords
- MCI, Alzheimer´s disease, Lewy Body Dementia, EEG
- Medical subject headings
- Cognitive Dysfunction, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG with SPR analysisDiagnostic test
qEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective MCI cohort | EEG with SPR analysis of the group from the study 2011-2013 is evaluated in relation to the status of current cognitive impairment Receives: Diagnostic Test: EEG with SPR analysis | |
| Prospective MCI cohort | New individuals diagnosed with MCI. EEG with SPR analysis is performed during the diagnostic work-up and evaluated in relation to changes in cognitive status during the following two years. Receives: Diagnostic Test: EEG with SPR analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of dementia
The type of dementia is registered
Measured: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration
Secondary outcomes (1)
CERAD ten word test
Immediate recall (0-30 words); delayed recall (0-10words) and recognition (0-20 words)
Measured: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jan 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jon Snaedal
- Sponsor type
- University, hospital or other
- Collaborators
- Ullevaal University Hospital, Karolinska University Hospital, Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital, Haukeland University Hospital, Kavli Research Foundation, Bergen Norway
- Responsible party
- Sponsor-investigator, Jon Snaedal, Landspitali University Hospital
- Investigators
- Knut Engedal, PhD, Study director, Ullevaal University Hospital. Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659643
- Sponsor's protocol ID
- NORD-MCI
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker
- ClinicalTrials.gov ID
- NCT03659643
- Acronym / sponsor ID
- NORD-MCI
- Conditions
- Mild Cognitive Impairment
- Keywords
- MCI, Alzheimer´s disease, Lewy Body Dementia, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jon SnaedalUniversity, hospital or other
- Collaborators
- Ullevaal University Hospital, Karolinska University Hospital, Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital, Haukeland University Hospital, Kavli Research Foundation, Bergen Norway
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 6 Sep 2018 (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.
Multi center study of six Memory Clinics in four Nordic countries in validating a prognostic diagnostic investigation of qEEG in Mild Cognitive Impairment (MCI). The study is in two parts, the first one is a follow up of a previous study conducted in 2011-2013 and the second half is new recruitment with two years follow up. End points are diagnosis of a dementing disorder, primarily dementia of Alzheimer´s type.
Detailed description
The Nordic Network in Dementia Diagnostics (NIDD) conducted a study in 2011-2013 on qEEG using a method of Statistical Pattern Recognition (SPR) in six academic Memory Clinics in four Nordic countries. In the current study, those from the former study diagnosed either with Mild Cognitive Impairment (MCI; n= 120) or with Subjective Cognitive Impairment (SCI; n=60) are contacted again and evaluated for cognitive impairment. The EEG registered at entry in the former study is considered in relation to their current diagnosis (SCI,MCI or dementia) and thereby, the prognostic value of the method is evaluated.
In the second part of the study (n=120), new patients evaluated in the Memory Clinics and diagnosed with MCI (not SCI) are invited to participate for a two year follow up.
In the diagnostic work-up, simple screening tests and information from a close relative form the basis of the cognitive status (SCI;MCI, Dementia). In evaluating the cause of cognitive impairment, detailed neuropsychological testing is performed as well as MRI of the brain and CSF for Alzheimer´s markers. qEEG with SPR analysis is registered but the clinician is blinded to its outcome.
The end point in both parts of the study is a diagnosis of a dementing disorder.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective MCI cohort | – | Diagnostic Test: EEG with SPR analysisEEG with SPR analysis of the group from the study 2011-2013 is evaluated in relation to the status of current cognitive impairment |
| Prospective MCI cohort | – | Diagnostic Test: EEG with SPR analysisNew individuals diagnosed with MCI. EEG with SPR analysis is performed during the diagnostic work-up and evaluated in relation to changes in cognitive status during the following two years. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals referred for diagnostic evaluation to an academic Memory Clinic (MC) in either of the six participating centers. Group 1: Individuals diagnosed with either SCI or MCI in a study by the same centers in 2011-2013 Group 2: Individuals referred to the same academic MC, diagnosed with the cognitive status of MCI at the first visit. They are followed up for 2 years for evaluation of their cognitive status and if diagnosed with dementia, their disorder is registered.
Key inclusion criteria (2 listed)
- Group 1: Individuals diagnosed with either SCI or MCI during 2011-2013 Group 2: Individuals diagnosed with MCI at entry of the study
- -
Key exclusion criteria (3 listed)
- Age <50 years or >85 years
- Medically or psychologically unstable
- Living outside the capital region
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 with SPR analysisqEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed. | Diagnostic test | Prospective MCI cohort, Retrospective MCI cohort |
Primary outcome
Diagnosis of dementia
Time frame: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration
The type of dementia is registered
1 secondary outcome
CERAD ten word test
Time frame: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- 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.
Knut Engedal, PhD study director
Ullevaal University Hospital. Oslo, Norway
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 Jon Snaedal at 1 site in Iceland.
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 2 inclusion and 3 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 6 Sep 2018. 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 Iceland. 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 Jon Snaedal, MD (+354 864 0478, jsnaedal@landspitali.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of dementia (time frame: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration). 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 6 Sep 2018.