Cognitive Stimulation in Older Adults With Alzheimer's Disease

NCT07041008 | Completed

• 1 other identifier: 13062025
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 39

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.

Conditions

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

Keywords

older adults; cognitive function; memory; executive function; dementia; cognitive stimulation therapy; cognition; neurocognitive disorders; individual therapy; non-pharmacological therapy; mood; depression; anxiety; quality of life; randomised controlled trial; Alzheimer's disease

Outcome Measures

Primary Outcomes (12)

• Cognitive functioning assessed through Mini-Mental State Examination (MMSE)

  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.

  Baseline

• Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)

  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.

  12 weeks after the baseline

• Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)

  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.

  24 weeks after the baseline

• Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

  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.

  Baseline

• Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

  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.

  12 weeks after the baseline

• Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)

  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.

  24 weeks after the baseline

• Memory function evaluated through Memory Alteration Test (MAT)

  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.

  Baseline

• Change in memory function evaluated through Memory Alteration Test (MAT)

  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.

  12 weeks after the baseline

• Change in memory function evaluated through Memory Alteration Test (MAT)

  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.

  24 weeks after the baseline

• Executive functions assessed through Frontal Assessment Battery (FAB)

  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.

  Baseline

• Change in executive functions assessed through Frontal Assessment Battery (FAB)

  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.

  12 weeks after the baseline

• Change in executive functions assessed through Frontal Assessment Battery (FAB)

  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.

  24 weeks after the baseline

Secondary Outcomes (9)

• Mood assessed through the Geriatric Depression Scale-15 (GDS-15)

  Baseline

• Change in mood assessed through the GDS-15

  12 weeks after the baseline

• Change in mood assessed through the GDS-15

  24 weeks after the baseline

• Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)

  Baseline

• Change in anxiety symptomatology assessed through the GAI

  12 weeks after the baseline

Other Outcomes (2)

• Sociodemographic, geographical and social information collected through the Sociodemographic, Geographical and Social Characteristics Questionnaire

  Baseline

• Adherence to the intervention and dropouts evaluated through a session form

  up to 12 weeks after baseline

Study Arms (3)

Intervention group 1

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.

Behavioral: Digital intervention

Intervention group 2

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.

Behavioral: Physical/Analogue Intervention

Control group (No intervention)

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.

Interventions

Digital intervention BEHAVIORAL

Individual cognitive stimulation sessions will be delivered using RehaCom software, which provides adaptive, computerised exercises targeting specific cognitive domains.

Intervention group 1

Physical/Analogue Intervention BEHAVIORAL

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.

Intervention group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rsocialform - Geriatria, Lda: lead

Study Sites (39)

AMITEI

Leiria, Leria, Portugal

Location

Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau

Funchal, Madeira, Portugal

Location

Instituto S. João de Deus Funchal

Funchal, Madeira, Portugal

Location

Associação Alzheimer Açores

Açores, Portugal

Location

Santa Casa da Misericórdia da Horta

Açores, Portugal

Location

Santa Casa da Misericórdia de Vila do Porto

Açores, Portugal

Location

CASTIIS

Aveiro, Portugal

Location

CEDIARA - Associação de Solidariedade Social de Ribeira de Fráguas

Aveiro, Portugal

Location

Centro Apoio Social Mozelos

Aveiro, Portugal

Location

Centro Social da Freguesia de Casal Comba

Aveiro, Portugal

Location

O Jardim - Centro de Solidariedade Social de Canedo

Aveiro, Portugal

Location

Santa Casa da Misericórdia de Espinho

Aveiro, Portugal

Location

Santa Casa da Misericórdia de Ovar

Aveiro, Portugal

Location

Patronato de Santo António - Lar D. José do Patrocínio Dias

Beja, Portugal

Location

Santa Casa da Misericórdia de Ferreira do Alentejo

Beja, Portugal

Location

Centro Social do Vale do Homem Casa da Alegria

Braga, Portugal

Location

Santa Casa da Misericórdia de Mirandela

Bragança, Portugal

Location

Residência Sénior DON ANTÓNIO - Hilário & Pereira

Castelo Branco, Portugal

Location

Santa Casa da Misericórdia da Soalheira

Castelo Branco, Portugal

Location

Santa Casa da Misericórdia de Vila Velha de Rodão

Castelo Branco, Portugal

Location

Associação Cultural Recreativa e Social de Samuel

Coimbra, Portugal

Location

Santa Casa da Misericórdia de Montemor-o-Novo

Evora, Portugal

Location

Santa Casa da Misericórdia de Vila Real de Santo António

Faro, Portugal

Location

Fundação João Bento Raimundo

Guarda, Portugal

Location

Santa Casa da Misericórdia de Figueira de Castelo Rodrigo

Guarda, Portugal

Location

Santa Casa da Misericórdia de Alcobaça

Leiria, Portugal

Location

Santa Casa da Misericórdia de Alvaiázere

Leiria, Portugal

Location

Santa Casa da Misericórdia de Alvorge

Leiria, Portugal

Location

Associação Casapiana de Solidariedade

Lisbon, Portugal

Location

Associação de Socorros da Freguesia de Turcifal

Lisbon, Portugal

Location

Centro Social Paroquial de Moita dos Ferreiros

Lisbon, Portugal

Location

Santa Casa da Misericórdia de Lisboa - Espaço ComVida

Lisbon, Portugal

Location

Santa Casa da Misericórdia de Campo Maior

Portalegre, Portugal

Location

Santa Casa da Misericórdia de Gaia - ERPI José Tavares Bastos

Porto, Portugal

Location

Quinta de Santa Ana RS

Viana do Castelo, Portugal

Location

Santa Casa da Misericórdia de Caminha

Viana do Castelo, Portugal

Location

Santa Casa da Misericórdia de Ponte de Lima

Viana do Castelo, Portugal

Location

Associação de Solidariedade Social do Alto Paiva

Viseu, Portugal

Location

Associação de Solidariedade Social e Recreativa de Nespereira

Viseu, Portugal

Location

MeSH Terms

Conditions

Dementia; Neurocognitive Disorders; Cognitive Dysfunction; Depression; Anxiety Disorders; Alzheimer Disease

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders; Behavioral Symptoms; Behavior; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Susana I. Justo Henriques, PhD

  Polytechnic University of Beja

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 27, 2025
• Study Start: September 1, 2025
• Primary Completion: September 13, 2025
• Study Completion: March 13, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (39)