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CST+MST Intervention on People Living With Mild-to-moderate Dementia

NCT07625241 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2026-06-04

No results posted yet for this study

Summary

Non-pharmacological interventions such as Cognitive Stimulation Therapy (CST) and physical activity are recommended for people living with mild-to-moderate dementia. Emerging evidence suggests that combining cognitive and motor interventions may provide synergistic benefits on cognition, mobility, and functional abilities. This study aims to evaluate the effectiveness of a combined CST and Motor Stimulation Treatment (MST) programme.

This multicenter quasi-experimental study will involve 30 clinical centers across five Italian regions. Participants aged ≥65 years with mild-to-moderate dementia will receive 14 combined CST+MST sessions delivered twice weekly over 7 weeks. Assessments will be conducted at baseline, post-intervention, and after 14 weeks by the end of the interventions. Primary outcomes include proportion of responders on the Mini-Mental State Examination (≥2.32 points) and Timed Up and Go test (≥1 point). Secondary outcomes include cognitive, motor, functional, psychological, and caregiver-related measures.

Ethical approval was obtained from the Italian National Ethics Committee in July 2025 (reference number: 2025\_0032251). Written informed consent will be obtained from participants and/or their legal representatives, as well as from caregivers involved in the study. All procedures will comply with the Declaration of Helsinki and national data protection regulations. Study findings will be disseminated through peer-reviewed scientific publications and presentations at national and international conferences.

Conditions

Interventions

BEHAVIORAL

Cognitive Stimulation Therapy and Motor Stimulation Treatment

The intervention will consist of a total of 14 sessions lasting 2 hours each over 7 weeks (twice a week). The intervention will be delivered in groups of 6-8 patients with similar cognitive abilities and will always be carried out by two operators, a psychologist and a physiotherapist. The space will be large enough to allow patients to walk easily in a circle; however, adjustments may be made (e.g. walking on the spot). Each session will consist of an initial 45-minute CST session followed by an MST session. The short break scheduled in the CST protocol will be postponed until the end of this intervention and before the MST session.

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07625241 on ClinicalTrials.gov