Effect of Individual Cognitive Stimulation on Memory and Executive Function in Older Adults With Alzheimer's Disease

NCT ID: NCT05433493

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-10-06

Brief Summary

This multicentre study, with a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions, which provide care and supportive services for older adults diagnosed with mild or moderate Alzheimer's disease (AD), with an aim to assess the effect of individual cognitive stimulation (CS) on memory and executive functioning. Participants in the intervention group will attend 24 individual CS sessions, twice weekly for 12 weeks. Participants in the control group will complete their usual routines without any activity restrictions.

Detailed Description

Neurocognitive disorders (NCD) currently affect around 55 million people worldwide and expected to increase to 78 million by 2030 and 139 million by 2050, with Alzheimer's disease (AD) potentially accounting for 60-70% of dementia cases. Dementia is a syndrome, generally chronic or progressive in nature, that causes deterioration of cognitive function, particularly memory and executive functions, beyond what is expected in normal aging. However, there is evidence that in the early stages of NCD, people can learn and improve their cognitive functions through interventions such as CS. CS is a psychosocial intervention and a non-pharmacological therapy recommended by international practice guidelines for people with mild-to-moderate stage AD. However, it is also important to investigate whether NCD generates new skills or only preserves acquired skills, given that AD manifests initially and notably with deficits in memory and learning, sometimes accompanied by deficits in executive functions. Testing the effectiveness of CS by recruiting a representative sample from several Portuguese districts and using a CS programme with detailed and comprehendible content, may elicit relevant evidence in clinical practice, contribute to the development of social development programs and initiatives to ensure social protection and inclusion, promote recurrent therapeutic interventions in Portuguese institutions with provide care and supporting services for older adults with dementia, and strengthen research on non-pharmacological therapies. Thus, this multicentre, randomised controlled study is essential to analyse the effects of the individual CS on global cognitive function and specific cognitive domains (e.g., executive functioning, memory) in older adults with mild or moderate AD.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving individual CS or to the control group receiving treatment as usual (participating in the activities previously established in their individual intervention plan).

Participants in the intervention group 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 protocol in every participant site.

Group Type: EXPERIMENTAL

Cognitive stimulation

Intervention Type: BEHAVIORAL

The intervention program will have 24 sessions (base scheme of 4 series of 6 sessions), lasting approximately 45 min and will be developed according to the following structure: - welcoming (greeting to the participant) (5 min); - orientation to reality (10 min); - main cognitive stimulation activity (25 min); - return to calm and evaluation of the session (5 min).

The CS sessions will have an individual format and will be conducted by a professional with experience in CS and previously trained in this intervention. The intervention sessions will include several activities based on the CS principles, with evidence suggesting positive participant effects. The CS sessions will be carried out using material, developed by the principal investigator, in digital format (power point presentations). There will be no repetition of activities, and throughout the base CS program, the degree of difficulty of the exercises will be adjusted based on the dementia stage of the participant.

Control group

Participants in the control group will receive treatment/activities as usual, participating in the activities previously established in their individual intervention plan.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive stimulation

The intervention program will have 24 sessions (base scheme of 4 series of 6 sessions), lasting approximately 45 min and will be developed according to the following structure: - welcoming (greeting to the participant) (5 min); - orientation to reality (10 min); - main cognitive stimulation activity (25 min); - return to calm and evaluation of the session (5 min).

The CS sessions will have an individual format and will be conducted by a professional with experience in CS and previously trained in this intervention. The intervention sessions will include several activities based on the CS principles, with evidence suggesting positive participant effects. The CS sessions will be carried out using material, developed by the principal investigator, in digital format (power point presentations). There will be no repetition of activities, and throughout the base CS program, the degree of difficulty of the exercises will be adjusted based on the dementia stage of the participant.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 65 or over.
• Receive care and support services for older adults for at least three months.
• Alzheimer's disease, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
• Ability to communicate and understand.
• Native speakers of Portuguese.
• To have given informed consent for the project, duly completed and signed, after previous information.
• Total scores between 10 and 24 points on the Mini Mental State Examination.

Exclusion Criteria

• Cannot read and write.
• Severe sensory and physical limitations and/or an acute or serious illness preventing participation in the CS sessions.
• Evidence of aggressive and disruptive behaviour, as indicated by the reference technicians of the institution to which the participant is linked.
• Consumption of psychoactive substances, taking neuroleptics and/or antipsychotics in the last two months.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aveiro University

OTHER

Sponsor Role: collaborator

Rsocialform - Geriatria, Lda

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susana I Justo Henriques, PhD

Role: PRINCIPAL_INVESTIGATOR

Nursing School of Coimbra

Óscar Ribeiro, PhD

Role: STUDY_DIRECTOR

Aveiro University

Locations

Rsocialform - Geriatria, Lda

Mealhada, Aveiro District, Portugal

Santa Casa da Misericórdia da Horta

Açores, , Portugal

Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

Aveiro, , Portugal

Centro Social e Cultural S. Pedro de Bairro

Braga, , Portugal

Centro Social Vale do Homem - Casa da Alegria

Braga, , Portugal

Santa Casa da Misericórdia de Castro Marim

Faro, , Portugal

Fundação João Bento Raimundo

Guarda, , Portugal

Santa Casa da Misericórdia de Alcobaça

Leiria, , Portugal

Associação de Socorros da Freguesia de Turcifal

Lisbon, , Portugal

Centro de Apoio Social de Oeiras - IASFA

Lisbon, , Portugal

Inválidos do Comércio

Lisbon, , Portugal

Associação de Apoio Social de Perafita

Porto, , Portugal

Santa Casa da Misericórdia de Coruche

Santarém, , Portugal

Santa Casa da Misericórdia de Ponte de Lima

Viana do Castelo, , Portugal

Countries

Portugal

References

Justo-Henriques SI, Lemos R, Rahmatpour P, Silva RCG, Carvalho JO, Ribeiro O. Effectiveness of Individual Cognitive Stimulation on Cognition in Mild Alzheimer's Disease: A Multicenter RCT. Psychogeriatrics. 2025 Nov;25(6):e70109. doi: 10.1111/psyg.70109.

Reference Type: DERIVED

PMID: 41139428 (View on PubMed)

Other Identifiers

20220621

Identifier Type: -

Identifier Source: org_study_id