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NCT Number: NCT07625241

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE"

Genova, 16132, Italy

Location status: Recruiting

Location contact

Claudio Ivaldi

CONTACT

[email protected]

+39 3477569654

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: CST, MST

Primary outcomes

  1. Mini Mental State Examination (MMSE)

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

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

  2. Timed and Up Go Test (TUG)

    Time frame: Baseline, week 7, and week 14

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ernesto Palummeri

CONTACT

[email protected]

+39 3312627145

Sponsors and collaborators

Lead sponsor

Istituto Superiore di Sanità

Other

Registry information

Official study title

Outcome Research Study on the Evaluation of a Combined Treatment of Cognitive Stimulation Therapy and Group Motor Stimulation in People With Mild-to-Moderate Dementia

Acronym: CST+MST

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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