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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Roskilde County Hospital
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Malene Schjønning Nielsen, Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT01642420
First received: April 13, 2012
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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
Alzheimers Disease
Mild Cognitive Impairment

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • Conversion from Mild Cognitive Impairment to Alzheimers disease [ Time Frame: Every year in totally of 3 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Cerebrospinalfluid (CSF) CSF is analysed to find Alzheimer Disease biomarkers


Estimated Enrollment: 115
Study Start Date: April 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mild cognitive impairment
Patients diagnosed with mild cognitive impairment
Alzheimers disease
Patients diagnosed with mild Alzheimers disease
Healthy control persons
Age matched healthy persons

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with MCI and AD will be recruitted among consectutively refered patients in a memory clinic. Participation is voluntary Healthy control persons will be recuitted by posters and notices

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642420

Contacts
Contact: Malene s Nielsen, MD 0045 2868 0034 malni@regionsjaelland.dk
Contact: Peter Høgh, MD, Ph.D 0045 4732 2809 phh@regionsjaelland.dk

Locations
Denmark
Neurologisk Afd, Roskilde Sygehus Recruiting
Roskilde, Denmark, 4000
Principal Investigator: Malene S Nielsen, MD         
Sponsors and Collaborators
Roskilde County Hospital
Rigshospitalet, Denmark
Investigators
Principal Investigator: Malene S Nielsen, MD Roskilde Hospital, Department of Neurology
  More Information

No publications provided

Responsible Party: Malene Schjønning Nielsen, MD, PhD student, Roskilde County Hospital
ClinicalTrials.gov Identifier: NCT01642420     History of Changes
Other Study ID Numbers: DEMPROG 2012
Study First Received: April 13, 2012
Last Updated: September 12, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Disease Progression
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Disease Attributes
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014