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

NCT07625241 | Recruiting

• 1 other identifier: 2025_0032251
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief 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

Dementia

Keywords

dementia; combined intervention; cognitive stimulation therapy; cst; motor stimulation treatment

Outcome Measures

Primary Outcomes (2)

• Mini Mental State Examination (MMSE)

  A screening neuropsychological test assessing cognitive global function. The total score is 30. Higher scores indicate better cognitive performance.

  The test will be administered at baseline, at week 7 and at week 14

• Timed and Up Go Test (TUG)

  TUG test is a simple clinical measure of functional mobility and fall risk. It records the time (in seconds) needed to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Scores are interpreted as follows: lower times indicate better mobility, with \<10 seconds generally considered normal, 10-20 seconds indicating mild mobility impairment, and \>20-30 seconds suggesting increased fall risk and functional limitation, depending on clinical context.

  Baseline, week 7, and week 14

Study Arms (1)

People living with mild-to-moderate dementia

EXPERIMENTAL

People living with mild-to-moderate dementia being able to perform a Timed Up and Go test (TUG) regardless of the time taken, i.e. being able to walk independently or with assistance, but without the need for human help during the test, and having no hearing or visual impairments of a degree that would preclude participation in the interventions.

Behavioral: Cognitive Stimulation Therapy and Motor Stimulation Treatment

Interventions

Cognitive Stimulation Therapy and Motor Stimulation Treatment BEHAVIORAL

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.

Also known as: CST, MST

People living with mild-to-moderate dementia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥ 65 years;
• having been assessed by a Center for Dementia and Cognitive Disorders (CCDD) who diagnosed dementia with any etiology of mild to moderate severity;
• being able to perform a Timed Up and Go test (TUG) regardless of the time taken, i.e. being able to walk independently or with assistance, but without the need for human help during the test;
• having no hearing or visual impairments of a degree that would preclude participation in the interventions.

You may not qualify if:

• presence of specific behavioural disorders (delusions, hallucinations, agitation, anxiety, euphoria, disinhibition, irritability, wandering) of a degree that prevents participation in the interventions;
• diseases that contraindicate physical activity (e.g. severe heart failure).

Sponsors & Collaborators

• Istituto Superiore di Sanità: lead

Study Sites (1)

Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE"

Genova, Genova, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ernesto Palummeri

CONTACT

+39 3312627145; ernesto.palummeri@alisa.liguria.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 4, 2026
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the end of the study
• Access Criteria: Immediately after the first publication of the results. IPD wil be shared through scientific publications.

Locations

IT (1)