EEG Classification System for Dementia

Dementia Clinical Trial

Official title:

EEG Classification System for Dementia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02273921
• Other study ID #: MC-CT-002
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 29, 2014
• Last updated: October 22, 2014
• Start date: March 2005
• Est. completion date: June 2020

Study information

• Verified date: October 2014
• Source: Mentis Cura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iceland: Ministry of Health and Social Security
• Study type: Interventional

Clinical Trial 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. Healthy controls

2. Mild Cognitive Impairment

3. Alzheimers Disease (AD)

4. Lewy-body Dementia

5. Parkinsons Disease Dementia

6. Vascular Dementia (VaD)

7. Frontotemporal Dementia (FTD)

8. Depression

Other groups will be added if needed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Outside required age range

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• EEG recording
EEG is recorded once for each participant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mentis Cura	Landspitali University Hospital

References & Publications (3)

Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. Epub 2007 Aug 31. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No