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

• Conditions: Alzheimers Disease; Mild Cognitive Impairment

• Registration Number: NCT01642420
• Lead Sponsor: Zealand University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-13
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conversion from Mild Cognitive Impairment to Alzheimers disease	Every year in totally of 3 years	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.

Trial Locations

Locations (1)

Neurologisk Afd, Roskilde Sygehus; 🇩🇰 Roskilde, Denmark