Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Diagnostic test: EEG with SPR analysis

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Iceland
  • Reykjavík, Iceland
    • Recruiting
    • Landspitali University Hospital
    • Contact: Jon Snaedal, MD; Phone Number: 354 8640478; Email: jsnaedal@landspitali.is

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: EEG with SPR analysis; qEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed.
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.	Diagnostic test: EEG with SPR analysis; qEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jon Snaedal
• Collaborators: Karolinska University Hospital; Ullevaal University Hospital; Zealand University Hospital; Rigshospitalet, Denmark; Haukeland University Hospital; Kavli Research Foundation, Bergen Norway
• Investigators: Study Director: Knut Engedal, PhD, Ullevaal University Hospital. Oslo, Norway

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: MCI; EEG; Lewy Body Dementia; Alzheimer´s disease
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NORD-MCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No