MedDataX Logo

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

NCT ID: NCT01642420

Last Updated: 2012-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimers Disease Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild cognitive impairment

Patients diagnosed with mild cognitive impairment

No interventions assigned to this group

Alzheimers disease

Patients diagnosed with mild Alzheimers disease

No interventions assigned to this group

Healthy control persons

Age matched healthy persons

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* meet the diagnostic criteria for MCI or AD
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Malene Schjønning Nielsen

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Malene S Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Roskilde Hospital, Department of Neurology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Neurologisk Afd, Roskilde Sygehus

Roskilde, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Malene s Nielsen, MD

Role: CONTACT

Phone: 0045 2868 0034

Email: [email protected]

Peter Høgh, MD, Ph.D

Role: CONTACT

Phone: 0045 4732 2809

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DEMPROG 2012

Identifier Type: -

Identifier Source: org_study_id