Clincosm LogoSign in Get a demo

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

Sponsor
Zealand University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01642420
Collaborator
Rigshospitalet, Denmark (Other)
115
Enrollment
1
Location
58.1
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    115 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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.
    Study Start Date :
    Apr 1, 2012
    Anticipated Primary Completion Date :
    Feb 1, 2017
    Anticipated Study Completion Date :
    Feb 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Mild cognitive impairment

    Patients diagnosed with mild cognitive impairment
    Alzheimers disease

    Patients diagnosed with mild Alzheimers disease
    Healthy control persons

    Age matched healthy persons

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neurologisk Afd, Roskilde Sygehus Roskilde Denmark 4000

    Sponsors and Collaborators

    • Zealand University Hospital
    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: Malene S Nielsen, MD, Roskilde Hospital, Department of Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Malene Schjønning Nielsen, MD, PhD student, Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT01642420
    Other Study ID Numbers:
    • DEMPROG 2012
    First Posted:
    Jul 17, 2012
    Last Update Posted:
    Sep 13, 2012
    Last Verified:
    Sep 1, 2012
    Additional relevant MeSH terms:
    Alzheimer Disease
    Dementia
    Disease Progression
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Sep 13, 2012