Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Diagnostic Test: EEG with SPR analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1: Individuals diagnosed with either SCI or MCI during 2011-2013 Group 2: Individuals diagnosed with MCI at entry of the study - Exclusion Criteria: Age <50 years or >85 years Medically or psychologically unstable Living outside the capital region

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective MCI cohort<br>EEG with SPR analysis of the group from the study 2011-2013 is evaluated in relation to the status of current cognitive impairment | Diagnostic Test: EEG with SPR analysis<br>* qEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed.<br>|
| Prospective MCI cohort<br>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. | Diagnostic Test: EEG with SPR analysis<br>* qEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of dementia | The type of dementia is registered | Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CERAD ten word test | Immediate recall (0-30 words); delayed recall (0-10words) and recognition (0-20 words) | Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, Alzheimer´s disease, Lewy Body Dementia, EEG