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Cognitive Stimulation Impact on Alzheimer's in Multiple Domains & Contexts

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Study Aim

This study investigates the impact of cognitive stimulation on Alzheimer's disease in multiple areas and contexts. It evaluates changes in cognitive functioning using tests like the Mini-Mental State Examination, Alzheimer's Disease Assessment Scale - Cognitive Subscale, Memory Alteration Test, and Frontal Assessment Battery.

What is being tested

Digital intervention

+ Physical/Analogue Intervention

Behavioral
Who is being recruted

Alzheimer Disease+12

+ Anxiety Disorders

+ Behavior

Over 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorRsocialform - Geriatria, Lda
Study ContactSusana I. Justo Henriques, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on older adults in Portugal who have mild to moderate Alzheimer's disease, a common form of dementia that affects memory, thinking, and daily functioning. As Portugal has a significant percentage of its elderly population affected by dementia, this research is crucial. The study aims to explore the effectiveness of cognitive stimulation, a non-drug approach that uses structured activities to improve mental functions such as memory, language, and reasoning. This approach is especially important because, while there is currently no cure for Alzheimer's, cognitive stimulation has shown promising results in enhancing cognition, mood, and quality of life for patients. Participants in the study will engage in different types of cognitive stimulation activities within social care settings. The study will measure the effects of these activities on participants' overall cognitive abilities, mood, and quality of life, with a particular focus on executive functions and memory. It will also consider how the resources available in different care facilities and geographic areas might affect these outcomes. By using reliable assessment tools and considering various contextual factors, the study aims to identify effective ways to implement cognitive stimulation that can be adapted to real-world care environments in Portugal.

Official TitleCognitive Stimulation in Older Adults With Alzheimer's Disease: Effects Across Multiple Domains and in Institutional and Sociogeographic Contexts
NCT07041008
Principal SponsorRsocialform - Geriatria, Lda
Study ContactSusana I. Justo Henriques, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

514 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseAnxiety DisordersBehaviorMental DisordersBehavioral SymptomsBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaDepressionNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesCognitive Dysfunction

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 39 locations

Recruiting

AMITEI

Leiria, PortugalOpen AMITEI in Google Maps
Recruiting

Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau

Funchal, Portugal
Recruiting

Instituto S. João de Deus Funchal

Funchal, Portugal
Recruiting

Associação Alzheimer Açores

Açores, Portugal
Recruiting
39 Study Centers
Cognitive Stimulation Impact on Alzheimer's in Multiple Domains & Contexts | PatLynk