Cognitive Stimulation in Older Adults With Alzheimer's Disease

Rsocialform - Geriatria, Lda

Status: Enrolling

Conditions: Cognitive Impairment; Cognitive Decline; Cognitive Dysfunction; Neurocognitive Disorders; Dementia

Treatments: Behavioral: Physical/Analogue Intervention; Behavioral: Digital intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07041008

13062025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 514 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 65 or older.
• 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

• Cannot read and write.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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514 participants in 3 patient groups

Intervention group 1

Experimental group

Description:

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.

Treatment:

Behavioral: Digital intervention

Intervention group 2

Experimental group

Description:

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.

Treatment:

Behavioral: Physical/Analogue Intervention

Control group (No intervention)

No Intervention group

Description:

Participants in the control group will receive treatment as usual (TAU) at the site, following the activities specified in their individual care plans.