Clinical trial NCT01642420: Non-expensive and Widely Available Tests as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimers Disease
Mild Cognitive Impairment
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2012-07-17
Enrollment: 115
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Conversion from Mild Cognitive Impairment to Alzheimers disease
timeFrame: Every year in totally of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Neurologisk Afd, Roskilde Sygehus
Study officials:
affiliation: Roskilde Hospital, Department of Neurology
name: Malene S Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References: