Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline (Cognichess)

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

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Subjective Cognitive Decline
• Intervention / Treatment: Other: Go classes; Other: Chess classes

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucio Tremolizzo, MD, PhD; Phone Number: +390392339082; Email: lucio.tremolizzo@unimib.it
• Study Contact Backup: Name: Federico Emanuele Pozzi, MD; Phone Number: +390392339082; Email: federicoemanuele.pozzi@gmail.com

Study Locations

• Italy
  • Lombardia
    • Monza, Lombardia, Italy, 20900
      • Recruiting
      • Fondazione IRCCS San Gerardo dei Tintori
      • Sub-Investigator: Federico Emanuele Pozzi, MD
      • Contact: Lucio Tremolizzo, MD, PhD; Phone Number: +390392339082; Email: lucio.tremolizzo@unimib.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects randomized to no intervention for 12 weeks
Experimental: Go classes; Subjects randomized to a group intervention with Go lessons once a week for 12 weeks	Other: Go classes; Classes of board games (Go), performed in groups of 6-10 subjects, once a week
Experimental: Chess classes; Subjects randomized to a group intervention with Chess lessons once a week for 12 weeks	Other: Chess classes; Classes of board games (Chess), performed in groups of 6-10 subjects, once a week
Experimental: Go & Chess classes; Subjects randomized to a group intervention with Go and Chess lessons twice a week for 12 weeks	Other: Go classes; Classes of board games (Go), performed in groups of 6-10 subjects, once a week; Other: Chess classes; Classes of board games (Chess), performed in groups of 6-10 subjects, once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General cognition	Differences in Montreal Cognitive Assessment between groups [continuous scale, 0-30, higher scores indicate better performances]	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digit Span Forward	Differences in Digit Span Forward between groups [continuous scale, 0-9, higher scores indicate better performances]	12 weeks
Digit Span Backwards	Differences in Digit Span Backwards between groups [continuous scale, 0-9, higher scores indicate better performances]	12 weeks
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
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
Semantic fluency	Differences in Semantic fluency between groups [continuous scale, min 0, max N/A, higher scores indicate better performances]	12 weeks
Depression	Differences in geriatric depression scale scale between groups [continuous scale, min 0 max 15, higher scores indicate worse depression]	12 weeks
Lifestyle	Differences in simple lifestyle indicator questionnaire scale between groups [continuous scale, min 0 max 10, higher scores indicate healthier lifestyle]	12 weeks
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

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Investigators: Principal Investigator: Lucio Tremolizzo, MD, PhD, Fondazione IRCCS San Gerardo

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): February 13, 2025
• Study Completion (Estimated): February 13, 2025

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Subjective Cognitive Decline; Cognitive enhancement; Board games
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Cognichess

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No