Mild Cognitive Impairment Clinical Trial
— CognichessOfficial title:
Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline
The goal of this clinical trial]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are: - Do Go and Chess improve cognition? - Is a game better than the other? Is the effect of both games on cognition synergistic? - Do Go and Chess improve quality of life? - Do Go and Chess improve mood? - Do Go and Chess improve lifestyle? Participants will be randomized to one of four groups: - Group intervention with Go, once a week, for 12 weeks - Group intervention with Chess, once a week, for 12 weeks - Group intervention with Go and Chess, twice a week, for 12 weeks - Control group
Status | Recruiting |
Enrollment | 80 |
Est. completion date | February 13, 2025 |
Est. primary completion date | February 13, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of mild cognitive impairment or subjective cognitive decline - Willingness to participate in the board games classes - Living within 20-minute driving distance from the center - Signed informed consent Exclusion Criteria: - Prior knowledge of the the game rules (in case the subject knows one of the two, they can be randomized to the other one) - Significant linguistic or sensory impairment (according to clinical judgment) - Significant behavioral or psychiatric disturbances (according to clinical judgment) - Significant medical comorbidities (according to clinical judgment) |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS San Gerardo dei Tintori | Monza | Lombardia |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | General cognition | Differences in Montreal Cognitive Assessment between groups [continuous scale, 0-30, higher scores indicate better performances] | 12 weeks | |
Secondary | Digit Span Forward | Differences in Digit Span Forward between groups [continuous scale, 0-9, higher scores indicate better performances] | 12 weeks | |
Secondary | Digit Span Backwards | Differences in Digit Span Backwards between groups [continuous scale, 0-9, higher scores indicate better performances] | 12 weeks | |
Secondary | Trail Making Test - part A | Differences in Trail Making Test - part A between groups [time to complete the task, min 0 seconds, max N/A, higher scores indicate worse performances] | 12 weeks | |
Secondary | Trail Making Test - part B | Differences in Trail Making Test - part B between groups [time to complete the task, min 0 seconds, max N/A, higher scores indicate worse performances] | 12 weeks | |
Secondary | Semantic fluency | Differences in Semantic fluency between groups [continuous scale, min 0, max N/A, higher scores indicate better performances] | 12 weeks | |
Secondary | Quality of life indicator | Differences in WHO Quality of life (WHO-QoL) scale between groups [continuous scale, min 0 max 100, higher scores indicate better quality of life] | 12 weeks | |
Secondary | Depression | Differences in geriatric depression scale scale between groups [continuous scale, min 0 max 15, higher scores indicate worse depression] | 12 weeks | |
Secondary | Lifestyle | Differences in simple lifestyle indicator questionnaire scale between groups [continuous scale, min 0 max 10, higher scores indicate healthier lifestyle] | 12 weeks |
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