NCT02273921

Brief Summary

The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups. In the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. The categorization is performed during the data analysis. The groups in the data analysis will initially be based on the following:

  1. 1.Healthy controls
  2. 2.Mild Cognitive Impairment
  3. 3.Alzheimers Disease (AD)
  4. 4.Lewy-body Dementia
  5. 5.Parkinsons Disease Dementia
  6. 6.Vascular Dementia (VaD)
  7. 7.Frontotemporal Dementia (FTD)
  8. 8.Depression

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

15.3 years

First QC Date

September 29, 2014

Last Update Submit

October 22, 2014

Conditions

Keywords

Dementia, Diagnosis, Electroencephalography

Outcome Measures

Primary Outcomes (1)

  • Classification system for dementia based on EEG

    The EEGs recorded in the trial will be categorized into controls or predefined clinical groups based on the participants' clinical diagnosis. The classification system will be constructed using this categorization.

    The quality of the classification system will be evaluated regularly, at least every 6 months, up to 6 years.

Study Arms (1)

EEG

NO INTERVENTION

A non-invasive EEG recording

Other: EEG recording

Interventions

EEG is recorded once for each participant

EEG

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of participant in the range of 50-90 years

You may not qualify if:

  • Outside required age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Snaedal J, Johannesson GH, Gudmundsson TE, Gudmundsson S, Pajdak TH, Johnsen K. The use of EEG in Alzheimer's disease, with and without scopolamine - a pilot study. Clin Neurophysiol. 2010 Jun;121(6):836-41. doi: 10.1016/j.clinph.2010.01.008. Epub 2010 Feb 12.

    PMID: 20153691BACKGROUND
  • Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.

    PMID: 17765604BACKGROUND
  • Snaedal J, Johannesson GH, Gudmundsson TE, Blin NP, Emilsdottir AL, Einarsson B, Johnsen K. Diagnostic accuracy of statistical pattern recognition of electroencephalogram registration in evaluation of cognitive impairment and dementia. Dement Geriatr Cogn Disord. 2012;34(1):51-60. doi: 10.1159/000339996. Epub 2012 Aug 23.

MeSH Terms

Conditions

DementiaDisease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jón Snædal, MD

    Landspitali University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 24, 2014

Study Start

March 1, 2005

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

October 24, 2014

Record last verified: 2014-10