Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline

NCT ID: NCT06281652

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-13
• Study Completion Date: 2025-02-13

Brief 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

Conditions

Mild Cognitive Impairment; Subjective Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Go classes

Subjects randomized to a group intervention with Go lessons once a week for 12 weeks

Group Type: EXPERIMENTAL

Go classes

Intervention Type: OTHER

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

Chess classes

Subjects randomized to a group intervention with Chess lessons once a week for 12 weeks

Group Type: EXPERIMENTAL

Chess classes

Intervention Type: OTHER

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

Go & Chess classes

Subjects randomized to a group intervention with Go and Chess lessons twice a week for 12 weeks

Group Type: EXPERIMENTAL

Go classes

Intervention Type: OTHER

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

Chess classes

Intervention Type: OTHER

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

Control

Subjects randomized to no intervention for 12 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Go classes

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

Intervention Type: OTHER

Chess classes

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucio Tremolizzo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS San Gerardo

Locations

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lucio Tremolizzo, MD, PhD

Role: CONTACT

lucio.tremolizzo@unimib.it

+390392339082

Federico Emanuele Pozzi, MD

Role: CONTACT

federicoemanuele.pozzi@gmail.com

+390392339082

Facility Contacts

Lucio Tremolizzo, MD, PhD

Role: primary

lucio.tremolizzo@unimib.it

+390392339082

Other Identifiers

Cognichess

Identifier Type: -

Identifier Source: org_study_id