NCT06372002 · ACTIVE NOT RECRUITING
Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia
This trial is testing a structured group activity program called Cognitive Stimulation Therapy, adapted for Spanish speakers, to see whether it improves thinking skills and quality of life in people with mild to moderate dementia. Participants either join 7 weeks of sessions plus 6 months of maintenance sessions, or continue their usual care. This is a Phase NA pragmatic trial — meaning it is testing real-world effectiveness, not an early-stage safety study.
Inclusion criteria
- Users of any of the sites (Associations of Families of People with Dementia) participating in the study.
- Individuals with a clinical diagnosis of neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; APA, 2013), including Alzheimer's Disease (AD), Vascular Dementia (VD), mixed dementia (MxD), Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Mild cognitive impairment or dementia due to Parkinson's disease (PD).
- Mild cognitive impairment or mild to moderate dementia (MMSE greater than 10).
- People who can be able to communicate and understand enough to participate in group activities.
- People who can participate in a group activity for at least 45 minutes.
- Signing of informed consent by the person with dementia or the legal guardian.
Exclusion criteria
- Presence of sensory limitations that prevent participation in the sessions.
- Health problems that prevent or hinder their participation in the sessions.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-04-17