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

NCT01642420 | Unknown

• 1 other identifier: DEMPROG 2012
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimers Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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 Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• meet the diagnostic criteria for MCI or AD

Sponsors & Collaborators

• Zealand University Hospital: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Neurologisk Afd, Roskilde Sygehus

Roskilde, 4000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Malene S Nielsen, MD

  Roskilde Hospital, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malene s Nielsen, MD

CONTACT

0045 2868 0034; malni@regionsjaelland.dk

Peter Høgh, MD, Ph.D

CONTACT

0045 4732 2809; phh@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: July 17, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

DK (1)