Mild Cognitive ImpairmentNCT02310620
Computer Games to Prevent Mild Cognitive Impairment and Dementia
A study testing Cognitive training in people with Mild Cognitive Impairment, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of the study is to show that regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent mild cognitive impairment (MCI) and dementia. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteHungary
- Study dates
- Dec 2012to Dec 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both gender
- Older than 50 years of age
Who cannot join
- Subjects with history of head trauma, epilepsy or stroke.
- Diagnosis of schizophrenia
- Acute manic episode
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to show that regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent mild cognitive impairment (MCI) and dementia.
The secondary aim of the study is to find correlations between the results of the games and the standard assessments for dementia and MCI screening such as the Rey Verbal Learning Test.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Not described Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to Mild Cognitive Impairment (?CI) (Proportion of participants who develop MCI after 3 years)
Proportion of participants who develop MCI after 3 years
Measured: 3 years
Conversion to dementia (Proportion of participants who develop dementia after 3 years)
Proportion of participants who develop dementia after 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gábor Csukly, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310620
- Sponsor's protocol ID
- M3W2012
- Status last verified
- Nov 2021
- First submitted
- 2 Dec 2014
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Games to Prevent Mild Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT02310620
- Acronym / sponsor ID
- M3W2012
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Dec 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 aim of the study is to show that regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent mild cognitive impairment (MCI) and dementia.
The secondary aim of the study is to find correlations between the results of the games and the standard assessments for dementia and MCI screening such as the Rey Verbal Learning Test.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both gender
- Older than 50 years of age
Key exclusion criteria (3 listed)
- Subjects with history of head trauma, epilepsy or stroke.
- Diagnosis of schizophrenia
- Acute manic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingregular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) | Behavioural | Cognitive Training |
Primary outcome
Conversion to Mild Cognitive Impairment (?CI) (Proportion of participants who develop MCI after 3 years)
Time frame: 3 years
Proportion of participants who develop MCI after 3 years
Conversion to dementia (Proportion of participants who develop dementia after 3 years)
Time frame: 3 years
Proportion of participants who develop dementia after 3 years
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 17 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Mild Cognitive Impairment, run by Semmelweis University at 1 site in Hungary.
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 3 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 17 Nov 2021. 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 Hungary. 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?
Conversion to Mild Cognitive Impairment (?CI) (Proportion of participants who develop MCI after 3 years) (time frame: 3 years). The study lists 2 primary outcomes in all. 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 17 Nov 2021.