Clinical trial NCT03659643: Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker
Official title: Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Keywords: MCI
Alzheimer´s disease
Lewy Body Dementia
EEG
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
Collaborators: name: Ullevaal University Hospital
name: Karolinska University Hospital
name: Rigshospitalet, Denmark
name: Zealand University Hospital
name: Haukeland University Hospital
name: Kavli Research Foundation, Bergen Norway
First posted: 2018-09-06
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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

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Exclusion Criteria:

* Age \<50 years or \>85 years
* Medically or psychologically unstable
* Living outside the capital region

Primary outcomes:
measure: Diagnosis of dementia
timeFrame: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration
Secondary outcomes:
measure: CERAD ten word test
timeFrame: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: Landspitali University Hospital
Study officials:
affiliation: Ullevaal University Hospital. Oslo, Norway
name: Knut Engedal, PhD
role: STUDY_DIRECTOR
References: