Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

• Conditions: Mild Cognitive Impairment
• Interventions: Diagnostic Test: EEG with SPR analysis

• Registration Number: NCT03659643
• Lead Sponsor: Jon Snaedal

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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-05
• Last Update Submitted: 2018-09-05
• Study First Posted: 2018-09-06
• Last Update Posted: 2018-09-06
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective MCI cohort	EEG with SPR analysis	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.
Retrospective MCI cohort	EEG with SPR analysis	EEG with SPR analysis of the group from the study 2011-2013 is evaluated in relation to the status of current cognitive impairment

Primary Outcome Measures

Name	Time	Method
Diagnosis of dementia	Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration	The type of dementia is registered

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Landspitali University Hospital; 🇮🇸 Reykjavík, Iceland