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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06281652
Other study ID # Cognichess
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 13, 2024
Est. completion date February 13, 2025

Study information

Verified date February 2024
Source University of Milano Bicocca
Contact Lucio Tremolizzo, MD, PhD
Phone +390392339082
Email lucio.tremolizzo@unimib.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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)

Study Design


Intervention

Other:
Go classes
Classes of board games (Go), performed in groups of 6-10 subjects, once a week
Chess classes
Classes of board games (Chess), performed in groups of 6-10 subjects, once a week

Locations

Country Name City State
Italy Fondazione IRCCS San Gerardo dei Tintori Monza Lombardia

Sponsors (1)

Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

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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