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

NCT05433493 | Completed

• 1 other identifier: 20220621
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 14

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.

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; randomised controlled trial; Alzheimer disease

Outcome Measures

Primary Outcomes (18)

• 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 beginning of the intervention

• 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 end of intervention

• 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 beginning of the intervention

• 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 end of intervention

• 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 beginning of the intervention

• 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 end of intervention

• Memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)

  FCSRT is a verbal learning and memory test that allows prompting the encoding and retrieval conditions by using semantic cues on learning and recall trials. It is composed of 16 semantically categorised, unrelated items/words.

  baseline

• Change in memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)

  FCSRT is a verbal learning and memory test that allows prompting the encoding and retrieval conditions by using semantic cues on learning and recall trials. It is composed of 16 semantically categorised, unrelated items/words.

  12 weeks after the beginning of the intervention

• Change in memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)

  FCSRT is a verbal learning and memory test that allows prompting the encoding and retrieval conditions by using semantic cues on learning and recall trials. It is composed of 16 semantically categorised, unrelated items/words.

  12 weeks after end of intervention

• 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 beginning of the intervention

• 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 end of intervention

• Executive functions assessed through Trail Making Test (TMT)

  TMT is one of the most widely used instruments in clinical and experimental neuropsychology. It is very sensitive to identify cognitive impairments, measuring simple motor and spatial skills, basic sequencing skills, mental flexibility, selective attention, visuo-perceptual skills, motor speed, and executive functions. Higher scores indicate greater impairment.

  baseline

• Change in executive functions assessed through Trail Making Test (TMT)

  TMT is one of the most widely used instruments in clinical and experimental neuropsychology. It is very sensitive to identify cognitive impairments, measuring simple motor and spatial skills, basic sequencing skills, mental flexibility, selective attention, visuo-perceptual skills, motor speed, and executive functions. Higher scores indicate greater impairment.

  12 weeks after the beginning of the intervention

• Change in executive functions assessed through Trail Making Test (TMT)

  TMT is one of the most widely used instruments in clinical and experimental neuropsychology. It is very sensitive to identify cognitive impairments, measuring simple motor and spatial skills, basic sequencing skills, mental flexibility, selective attention, visuo-perceptual skills, motor speed, and executive functions. Higher scores indicate greater impairment.

  12 weeks after end of intervention

Other Outcomes (2)

• Sociodemographic information gathered through the sociodemographic questionnaire

  baseline

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

  during the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Cognitive stimulation

Control group

NO INTERVENTION

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

Interventions

Cognitive stimulation 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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rsocialform - Geriatria, Lda: lead
• Aveiro University: collaborator

Study Sites (14)

Rsocialform - Geriatria, Lda

Mealhada, Aveiro District, 3050, Portugal

Location

Santa Casa da Misericórdia da Horta

Açores, Portugal

Location

Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

Aveiro, Portugal

Location

Centro Social e Cultural S. Pedro de Bairro

Braga, Portugal

Location

Centro Social Vale do Homem - Casa da Alegria

Braga, Portugal

Location

Santa Casa da Misericórdia de Castro Marim

Faro, Portugal

Location

Fundação João Bento Raimundo

Guarda, Portugal

Location

Santa Casa da Misericórdia de Alcobaça

Leiria, Portugal

Location

Associação de Socorros da Freguesia de Turcifal

Lisbon, Portugal

Location

Centro de Apoio Social de Oeiras - IASFA

Lisbon, Portugal

Location

Inválidos do Comércio

Lisbon, Portugal

Location

Associação de Apoio Social de Perafita

Porto, Portugal

Location

Santa Casa da Misericórdia de Coruche

Santarém, Portugal

Location

Santa Casa da Misericórdia de Ponte de Lima

Viana do Castelo, Portugal

Location

Related Publications (1)

• 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.

  PMID: 41139428 DERIVED

MeSH Terms

Conditions

Dementia; Neurocognitive Disorders; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Susana I Justo Henriques, PhD

  Nursing School of Coimbra

  PRINCIPAL INVESTIGATOR

• Óscar Ribeiro, PhD

  Aveiro University

  STUDY DIRECTOR

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: July 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: October 6, 2023
• Last Updated: October 16, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (14)