NCT07041008

Cognitive Stimulation in Older Adults With Alzheimer's Disease

Digital and Analogical Cognitive Stimulation in Older Adults With Alzheimer's Disease: Effects on Global Cognition, Well-being and Quality of Life Across Distinct Institutional and Sociogeographic Contexts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Rsocialform - Geriatria, Lda · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This multicentre study, employing a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions that provide care and support services for older adults diagnosed with mild to moderate Alzheimer's disease (AD). The primary aim is to evaluate the effects of two distinct cognitive stimulation modalities (digital vs physical/analogue). The study will assess the impact of individual cognitive stimulation on multiple domains - specifically cognitive function (with an emphasis on memory and executive function), mood, and quality of life - and investigate how institutional and territorial characteristics influence these effects, considering geographical and organisational diversity as potential moderating factors.

Detailed description

Population ageing has increased the prevalence of neurodegenerative diseases, with Alzheimer's disease (AD) being the most common form of dementia. Its wide-ranging impact on cognition, emotion, and daily function necessitates person-centred, multidimensional interventions. In Portugal, dementia affects around 9.5% of those aged 65+, underlining its public health relevance and the need for effective responses. In the absence of a cure, non-pharmacological interventions like cognitive stimulation (CS) have gained prominence. CS is an evidence-based, psychosocial approach involving structured activities that enhance cognitive functions such as memory, language, attention, and reasoning. Broader and more relational than cognitive training or rehabilitation, CS is effective-especially in mild to moderate AD-in improving cognition, mood, and quality of life. Portuguese and international guidelines support its use, with studies showing potential in reducing depression and anxiety in older adults. Behavioural and psychological symptoms of dementia (BPSD)-including agitation, apathy, aggression, anxiety, and sleep issues-are common in AD and often more disruptive than cognitive decline. These symptoms increase caregiver stress and the likelihood of institutionalisation. CS may alleviate BPSD through emotional engagement and behavioural regulation. Assessing CS efficacy requires reliable tools. The Mini-Mental State Examination is widely used in Portugal for cognitive screening, while the Alzheimer's Disease Assessment Scale - Cognitive Subscale is often used in clinical trials. As AD notably impairs executive functions, CS targeting these domains can support autonomy and adaptive behaviour. Contextual factors, such as institutional resources and geographic location, may influence CS outcomes. However, few studies consider these variables, despite their relevance for implementing sustainable, real-world interventions. This research adopts a multicentre, randomised controlled design to examine two individual CS modalities in older adults with mild to moderate AD attending Portuguese social care services. It aims to assess CS effects on global cognition (particularly executive function and memory), mood, and quality of life, and to explore how institutional and territorial factors shape outcomes. By combining validated measures, structured protocols, and a context-sensitive approach, the study seeks to support the implementation of effective, sustainable CS interventions within Portugal's care system.

Conditions

• Dementia
• Neurocognitive Disorders
• Cognitive Impairment
• Cognitive Dysfunction
• Cognitive Decline

Interventions

Type	Name	Description
BEHAVIORAL	Digital intervention	Individual cognitive stimulation sessions will be delivered using RehaCom software, which provides adaptive, computerised exercises targeting specific cognitive domains.
BEHAVIORAL	Physical/Analogue Intervention	Individual cognitive stimulation sessions will employ structured physical materials, specifically the 'Memories from North to South©' and 'Cognitive Domains' resources, applied on an alternating basis.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-09-13
• Completion: 2026-03-13
• First posted: 2025-06-27
• Last updated: 2026-03-25

Locations

39 sites across 1 country: Portugal