Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

NCT ID: NCT03659643

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

EEG with SPR analysis

Intervention Type DIAGNOSTIC_TEST

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.

EEG with SPR analysis

Intervention Type DIAGNOSTIC_TEST

qEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ullevaal University Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Kavli Research Foundation, Bergen Norway

UNKNOWN

Sponsor Role collaborator

Jon Snaedal

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jon Snaedal

Professor in Geriatric Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Knut Engedal, PhD

Role: STUDY_DIRECTOR

Ullevaal University Hospital. Oslo, Norway

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Landspitali University Hospital

Reykjavik, , Iceland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iceland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jon Snaedal, MD

Role: CONTACT

+354 864 0478

Halla Arnardottir, RN

Role: CONTACT

354 543 5711

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jon Snaedal, MD

Role: primary

8640478 ext. 354

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NORD-MCI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurofeedback in Alzheimer's Disease
NCT03790774 TERMINATED NA