Non-expensive and Widely Available Tests as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression

Mild Cognitive Impairment Clinical Trial

— DEMPROG  

Official title:

Quantitative Electroencephalography, Cerebrospinal Fluid Biomarkers, Linear CT Analyses and Timed Up and GO Dual Task as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01642420
• Other study ID #: DEMPROG 2012
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2012
• Last updated: September 12, 2012
• Start date: April 2012
• Est. completion date: February 2017

Study information

• Verified date: September 2012
• Source: Roskilde County Hospital
• Contact: Malene s Nielsen, MD
• Phone: 0045 2868 0034
• Email: malni[@]regionsjaelland.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

Alzheimers disease (AD) is the most common course of cognitive decline and thereby the course of more than half of all cases of dementia. A proper AD diagnosis is rested on a number of examinations and tests, which combined can make AD diagnosis likely. But no single test or examination can unambiguous determine whether the patient has AD or not. Comparatively no examination or test can with accuracy predict whether a healthy person or a person with only mild cognitive (MCI)impairment in time will evolve AD.

Quantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely available diagnostic methods, which have the potential to diagnose AD at an early stage in a reliable accurate way. But they also have the potential to predict which patients diagnosed with MCI have particular risk of developing dementia.

The purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT analyses and TUG-DT outcome and clinical features in healthy persons as well as patients with MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which patients with MCI will in time evolve AD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

For patients:

• age 50 to 90

• diagnosed with MCI or AD

• cerebrospinal fluid examination and EEG performed at baseline

For control persons:

• age 50 to 90

• MMSE score equal or above 26

• ACE score equal or above 85

• Normal physical examination, including normal blood samples, CT of cerebrum and EEG examination

Exclusion Criteria:

• Pregnant or breastfeeding

• psychiatric disease, former depression is allowed if antidepressive treatment has been initiated of a leat 3 months duration

• Neurologic or somatic disease, including former severe head trauma or neuroinfection

• Antipsychotic treatment

• Former severe abuse of alcohol, medication or drugs

• ECT treatment or anaesthesia within the last 3 months

• no closely related person to assist the patient

Additionally exclusion criteria for healthy control persons:

• meet the diagnostic criteria for MCI or AD

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimers Disease
• Cognition Disorders
• Disease Progression
• Mild Cognitive Impairment

Locations

Country	Name	City	State
Denmark	Neurologisk Afd, Roskilde Sygehus	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Roskilde County Hospital	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion from Mild Cognitive Impairment to Alzheimers disease	The primary outcome measure is progression of clinical symptoms to an extent where the formal NINCDS-ADRDA criteria for dementia is meet. The progression is based upon clinical symptoms as well as explorative determinants in form of clinical tests, CSF analysis and qEEG analysis.	Every year in totally of 3 years	No