Cognitive Stimulation in Older Adults With Alzheimer's Disease

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07041008
• Lead Sponsor: Rsocialform - Geriatria, Lda

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-08-15
• Primary Completion: 2025-09-01
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive functioning assessed through Mini-Mental State Examination (MMSE)	Baseline	Cognitive functioning assessed by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)	24 weeks after the baseline	Change in cognitive functioning evaluated by the Mini-Mental State Examination (MMSE), a gold standard screening tool for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)	Baseline	Evaluates the severity of cognitive deficits in AD in the following domains: memory, orientation, language, praxis and constructive capacity. The total score in the Portuguese version of ADAS-Cog is composed of 11 subtests in the cognitive part and varies between 0 (better performance) and 68 points (worse performance), i.e., higher scores equals better performance.
Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)	24 weeks after the baseline	Evaluates the severity of cognitive deficits in AD in the following domains: memory, orientation, language, praxis and constructive capacity. The total score in the Portuguese version of ADAS-Cog is composed of 11 subtests in the cognitive part and varies between 0 (better performance) and 68 points (worse performance), i.e., higher scores equals better performance.
Memory function evaluated through Memory Alteration Test (MAT)	Baseline	The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.
Change in memory function evaluated through Memory Alteration Test (MAT)	24 weeks after the baseline	The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.
Executive functions assessed through Frontal Assessment Battery (FAB)	Baseline	FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points with higher scores indicating better cognitive function.
Change in executive functions assessed through Frontal Assessment Battery (FAB)	24 weeks after the baseline	FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points with higher scores indicating better cognitive function.

Secondary Outcome Measures

Name	Time	Method
Mood assessed through the Geriatric Depression Scale-15 (GDS-15)	Baseline	The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.
Change in mood assessed through the GDS-15	24 weeks after the baseline	The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.
Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)	Baseline	It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.
Change in anxiety symptomatology assessed through the GAI	24 weeks after the baseline	It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.
Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)	Baseline	The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.
Change in quality of life evaluated through QoL-AD	24 weeks after the baseline	The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.