Alzheimers DiseaseDEMPROGNCT01642420
Non-expensive and Widely Available Tests as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression
An observational study of Alzheimers Disease and Mild Cognitive Impairment, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimers Disease, Mild Cognitive Impairment
- How many people
- 115 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- no closely related person to assist the patient
- Additionally exclusion criteria for healthy control persons:
- meet the diagnostic criteria for MCI or AD
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Neurologisk Afd, Roskilde Sygehus
Roskilde, 4000
Malene S Nielsen, MD
About this study
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.
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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every year in totally of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimers DiseaseStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Malene Schjønning Nielsen, Zealand University Hospital
- Investigators
- Malene S Nielsen, MD, Principal investigator, Roskilde Hospital, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642420
- Sponsor's protocol ID
- DEMPROG 2012
- Acronym
- DEMPROG
- Status last verified
- Sep 2012
- First submitted
- 13 Apr 2012
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01642420
- Acronym / sponsor ID
- DEMPROG / DEMPROG 2012
- Conditions
- Alzheimers Disease, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Apr 2012
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild cognitive impairment | – | –Patients diagnosed with mild cognitive impairment |
| Alzheimers disease | – | –Patients diagnosed with mild Alzheimers disease |
| Healthy control persons | – | –Age matched healthy persons |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- age 50 to 90
- diagnosed with MCI or AD
- cerebrospinal fluid examination and EEG performed at baseline
- age 50 to 90
- MMSE score equal or above 26
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Conversion from Mild Cognitive Impairment to Alzheimers disease
Time frame: Every year in totally of 3 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malene S Nielsen, MD principal investigator
Roskilde Hospital, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimers Disease and Mild Cognitive Impairment, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malene s Nielsen, MD (0045 2868 0034, malni@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion from Mild Cognitive Impairment to Alzheimers disease (time frame: Every year in totally of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2012.