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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment; Alzheimers Disease

• Study Type: Observational
• Enrollment (Anticipated): 115

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Recruiting
    • Neurologisk Afd, Roskilde Sygehus
    • Principal Investigator: Malene S Nielsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Mild cognitive impairment; Patients diagnosed with mild cognitive impairment
Alzheimers disease; Patients diagnosed with mild Alzheimers disease
Healthy control persons; Age matched healthy persons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Malene S Nielsen, MD, Roskilde Hospital, Department of Neurology

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Estimate): September 13, 2012
• Last Update Submitted That Met QC Criteria: September 12, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease Attributes; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Disease Progression; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: DEMPROG 2012