Digital and analogical cognitive stimulation in older adults with alzheimer's disease: a multicenter randomized controlled trial study protocol

The growing incidence of neurodegenerative diseases in older adults, with the prevalence of Alzheimer’s disease, progressively affects their quality of life. Cognitive stimulation is a psychosocial intervention that has shown consistent benefits in the lives of people with dementia from mild to moderate stages. The present study aims to evaluate the effectiveness of digital and analogical cognitive stimulation, when compared with usual care, on overall cognitive function, emotional state, and quality of life. It also aims to investigate whether institutional and territorial characteristics of social care services moderate these effects. This is a three-arm multicenter randomized controlled trial with repeated measures (pre-intervention, post-intervention, and follow-up). The intervention consists of 24 individually applied (digital and analogical) cognitive stimulation sessions, twice a week, for 12 weeks, in two intervention groups. The control group receives usual care. The study follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025), including the extension for non-pharmacological interventions. The sample size is estimated at 222 older adults with a probable diagnosis of mild to moderate Alzheimer’s disease. Sociodemographic, social, health and clinical data, as well as information on care provider institutions, will be collected and analyzed. Outcomes include cognition (global cognition, memory, and executive function), emotional state (anxiety and depression), and quality of life. All outcomes will be assessed at baseline, endpoint, and follow-up, with comparisons between the intervention groups and the control group.