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Computer Games to Prevent Mild Cognitive Impairment and Dementia

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

Hungary

Study Type

Interventional

Intervention

Cognitive training

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Both gender
Older than 50 years of age

Exclusion Criteria:

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

Sites / Locations

Department of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Training

Arm Description

Outcomes

Primary Outcome Measures

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

Proportion of participants who develop MCI after 3 years

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

Proportion of participants who develop dementia after 3 years

Secondary Outcome Measures

Full Information

NCT ID

NCT02310620

First Posted

December 2, 2014

Last Updated

November 9, 2021

Sponsor

Semmelweis University

1. Study Identification

Unique Protocol Identification Number

NCT02310620

Brief Title

Computer Games to Prevent Mild Cognitive Impairment and Dementia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Semmelweis University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Training

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Cognitive training

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Proportion of participants who develop MCI after 3 years

Time Frame

3 years

Title

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

Description

Proportion of participants who develop dementia after 3 years

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Both gender Older than 50 years of age Exclusion Criteria: Subjects with history of head trauma, epilepsy or stroke. Diagnosis of schizophrenia Acute manic episode

Facility Information:

Facility Name

Department of Psychiatry and Psychotherapy

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

Computer Games to Prevent Mild Cognitive Impairment and Dementia

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