Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

Mild Cognitive Impairment Clinical Trial

Official title:

Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03659643
• Other study ID #: NORD-MCI
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2018
• Source: Landspitali University Hospital
• Contact: Jon Snaedal, MD
• Phone: +354 864 0478
• Email: jsnaedal[@]landspitali.is
• Is FDA regulated: No
• Study type: Observational

Clinical 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 follow up. End points are diagnosis of a dementing disorder, primarily dementia of Alzheimer´s type.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Iceland	Landspitali University Hospital	Reykjavík

Sponsors (7)

Lead Sponsor	Collaborator
Jon Snaedal	Haukeland University Hospital, Karolinska University Hospital, Kavli Research Foundation, Bergen Norway, Rigshospitalet, Denmark, Ullevaal University Hospital, Zealand University Hospital

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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