Alzheimer's DiseaseNCT02041728
The Detection of Early Dementia With the Digital Game Memory
An observational study of Alzheimer's Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The investigators are going to test if it is possible to detect early dementia with the digital game "memory". The investigators are going to test 15 healthy people and 15 patients with early dementia. The test consists of playing the game "memory" several times. While playing, several parameters are stored. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Apr 2013
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: * healthy subjects of 75 or older * subjects with mild dementia of 75 or older
Who may be able to join
- healthy 75-plusser
- 75-plusser with early dementia
Who cannot join
- younger than 75
- patient with other cognitive impairments than dementia
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are going to test if it is possible to detect early dementia with the digital game "memory". The investigators are going to test 15 healthy people and 15 patients with early dementia.
The test consists of playing the game "memory" several times. While playing, several parameters are stored.
The investigators are going to test if any correlation can be found between these parameters and the cognitive state of the person as tested by the Mini-Mental status examination.
- Conditions
- Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of cognitive status with failures in a computerised memory game
Failure is defined as the number of trials for the memory task
Measured: The game will be played once during 10-30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jos Tournoy, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041728
- Sponsor's protocol ID
- S54845
- Status last verified
- Jan 2013
- First submitted
- 26 Jun 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Detection of Early Dementia With the Digital Game Memory
- ClinicalTrials.gov ID
- NCT02041728
- Acronym / sponsor ID
- S54845
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Jan 2014 (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.
The investigators are going to test if it is possible to detect early dementia with the digital game "memory". The investigators are going to test 15 healthy people and 15 patients with early dementia.
The test consists of playing the game "memory" several times. While playing, several parameters are stored.
The investigators are going to test if any correlation can be found between these parameters and the cognitive state of the person as tested by the Mini-Mental status examination.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- * healthy subjects of 75 or older * subjects with mild dementia of 75 or older
Key inclusion criteria (2 listed)
- healthy 75-plusser
- 75-plusser with early dementia
Key exclusion criteria (2 listed)
- younger than 75
- patient with other cognitive impairments than dementia
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
Association of cognitive status with failures in a computerised memory game
Time frame: The game will be played once during 10-30 minutes.
Failure is defined as the number of trials for the memory task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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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.
Jos Tournoy principal investigator
University of Leuven
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 Alzheimer's Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Jan 2014. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of cognitive status with failures in a computerised memory game (time frame: The game will be played once during 10-30 minutes.). 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 22 Jan 2014.