NCT02310620

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

December 2, 2014

Last Update Submit

November 9, 2021

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • Conversion to Mild Cognitive Impairment (?CI) (Proportion of participants who develop MCI after 3 years)

    Proportion of participants who develop MCI after 3 years

    3 years

  • Conversion to dementia (Proportion of participants who develop dementia after 3 years)

    Proportion of participants who develop dementia after 3 years

    3 years

Study Arms (1)

Cognitive Training

EXPERIMENTAL
Behavioral: Cognitive training

Interventions

Cognitive trainingBEHAVIORAL

regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/)

Cognitive Training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both gender
  • Older than 50 years of age

You may not qualify if:

  • Subjects with history of head trauma, epilepsy or stroke.
  • Diagnosis of schizophrenia
  • Acute manic episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy

Budapest, 1083, Hungary

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 8, 2014

Study Start

December 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

HU(1)