Cognitive Stimulation in Older Adults With Alzheimer's Disease
NCT ID: NCT07041008
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
514 participants
INTERVENTIONAL
2025-09-01
2026-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group 1
Participants in the intervention group 1 will participate in two individual CS sessions per week for 12 weeks in addition to their treatment as usual. The sessions will include the same program in every participant site.
Digital intervention
Individual cognitive stimulation sessions will be delivered using RehaCom software, which provides adaptive, computerised exercises targeting specific cognitive domains.
Intervention group 2
Participants in the intervention group 2 will participate in two individual CS sessions per week for 12 weeks in addition to their treatment as usual. The sessions will include the same program in every participant site.
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.
Control group (No intervention)
Participants in the control group will receive treatment as usual (TAU) at the site, following the activities specified in their individual care plans.
No interventions assigned to this group
Interventions
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Digital intervention
Individual cognitive stimulation sessions will be delivered using RehaCom software, which provides adaptive, computerised exercises targeting specific cognitive domains.
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.
Eligibility Criteria
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Inclusion Criteria
* Receive care/support services for at least three months.
* A diagnosis of probable AD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision.
* Preserved communication skills.
* Native Portuguese speaker.
* Total scores between 10 and 26 points on the Mini Mental State Examination.
Exclusion Criteria
* Significant sensory or physical limitations.
* Acute or chronic illness preventing participation.
* Severe communication impairment.
* Aggressive or disruptive behaviour.
* Recent initiation (within two months) of neuroleptics, antipsychotics, or other psychoactive medications.
65 Years
ALL
No
Sponsors
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Rsocialform - Geriatria, Lda
OTHER
Responsible Party
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Principal Investigators
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Susana I. Justo Henriques, PhD
Role: PRINCIPAL_INVESTIGATOR
Polytechnic University of Beja
Locations
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AMITEI
Leiria, Leria, Portugal
Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau
Funchal, Madeira, Portugal
Instituto S. João de Deus Funchal
Funchal, Madeira, Portugal
Associação Alzheimer Açores
Açores, , Portugal
Santa Casa da Misericórdia da Horta
Açores, , Portugal
Santa Casa da Misericórdia de Vila do Porto
Açores, , Portugal
CASTIIS
Aveiro, , Portugal
CEDIARA - Associação de Solidariedade Social de Ribeira de Fráguas
Aveiro, , Portugal
Centro Apoio Social Mozelos
Aveiro, , Portugal
Centro Social da Freguesia de Casal Comba
Aveiro, , Portugal
O Jardim - Centro de Solidariedade Social de Canedo
Aveiro, , Portugal
Santa Casa da Misericórdia de Espinho
Aveiro, , Portugal
Santa Casa da Misericórdia de Ovar
Aveiro, , Portugal
Patronato de Santo António - Lar D. José do Patrocínio Dias
Beja, , Portugal
Santa Casa da Misericórdia de Ferreira do Alentejo
Beja, , Portugal
Centro Social do Vale do Homem Casa da Alegria
Braga, , Portugal
Santa Casa da Misericórdia de Mirandela
Bragança, , Portugal
Residência Sénior DON ANTÓNIO - Hilário & Pereira
Castelo Branco, , Portugal
Santa Casa da Misericórdia da Soalheira
Castelo Branco, , Portugal
Santa Casa da Misericórdia de Vila Velha de Rodão
Castelo Branco, , Portugal
Associação Cultural Recreativa e Social de Samuel
Coimbra, , Portugal
Santa Casa da Misericórdia de Montemor-o-Novo
Evora, , Portugal
Santa Casa da Misericórdia de Vila Real de Santo António
Faro, , Portugal
Fundação João Bento Raimundo
Guarda, , Portugal
Santa Casa da Misericórdia de Figueira de Castelo Rodrigo
Guarda, , Portugal
Santa Casa da Misericórdia de Alcobaça
Leiria, , Portugal
Santa Casa da Misericórdia de Alvaiázere
Leiria, , Portugal
Santa Casa da Misericórdia de Alvorge
Leiria, , Portugal
Associação Casapiana de Solidariedade
Lisbon, , Portugal
Associação de Socorros da Freguesia de Turcifal
Lisbon, , Portugal
Centro Social Paroquial de Moita dos Ferreiros
Lisbon, , Portugal
Santa Casa da Misericórdia de Lisboa - Espaço ComVida
Lisbon, , Portugal
Santa Casa da Misericórdia de Campo Maior
Portalegre, , Portugal
Santa Casa da Misericórdia de Gaia - ERPI José Tavares Bastos
Porto, , Portugal
Quinta de Santa Ana RS
Viana do Castelo, , Portugal
Santa Casa da Misericórdia de Caminha
Viana do Castelo, , Portugal
Santa Casa da Misericórdia de Ponte de Lima
Viana do Castelo, , Portugal
Associação de Solidariedade Social do Alto Paiva
Viseu, , Portugal
Associação de Solidariedade Social e Recreativa de Nespereira
Viseu, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13062025
Identifier Type: -
Identifier Source: org_study_id
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