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

Primary Purpose

Dementia, Neurocognitive Disorders, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Cognitive stimulation
Sponsored by
Rsocialform - Geriatria, Lda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring older adults, cognitive function, memory, executive function, dementia, cognitive stimulation therapy, cognition, neurocognitive disorders, individual therapy, non-pharmacological therapy, randomised controlled trial, Alzheimer disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rsocialform - Geriatria, Lda
  • Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
  • Santa Casa da Misericórdia da Horta
  • Centro Social e Cultural S. Pedro de Bairro
  • Centro Social Vale do Homem - Casa da Alegria
  • Santa Casa da Misericórdia de Castro Marim
  • Fundação João Bento Raimundo
  • Santa Casa da Misericórdia de Alcobaça
  • Associação de Socorros da Freguesia de Turcifal
  • Centro de Apoio Social de Oeiras - IASFA
  • Inválidos do Comércio
  • Associação de Apoio Social de Perafita
  • Santa Casa da Misericórdia de Coruche
  • Santa Casa da Misericórdia de Ponte de Lima

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2022
Last Updated
October 13, 2023
Sponsor
Rsocialform - Geriatria, Lda
Collaborators
Aveiro University
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1. Study Identification

Unique Protocol Identification Number
NCT05433493
Brief Title
Effect of Individual Cognitive Stimulation on Memory and Executive Function in Older Adults With Alzheimer's Disease
Official Title
Effect of Individual Cognitive Stimulation on Memory and Executive Functioning in Older Adults With Mild to Moderate Alzheimer's Disease: A Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
October 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rsocialform - Geriatria, Lda
Collaborators
Aveiro University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive treatment/activities as usual, participating in the activities previously established in their individual intervention plan.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
baseline
Title
Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Change in cognitive functioning assessed through Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
12 weeks after end of intervention
Title
Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
Description
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.
Time Frame
baseline
Title
Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG)
Description
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.
Time Frame
12 weeks after end of intervention
Title
Memory function evaluated through Memory Alteration Test (MAT)
Description
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.
Time Frame
baseline
Title
Change in memory function evaluated through Memory Alteration Test (MAT)
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Change in memory function evaluated through Memory Alteration Test (MAT)
Description
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.
Time Frame
12 weeks after end of intervention
Title
Memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)
Description
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.
Time Frame
baseline
Title
Change in memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Change in memory function evaluated through Free and Cued Selective Reminding Test (FCSRT)
Description
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.
Time Frame
12 weeks after end of intervention
Title
Executive functions assessed through Frontal Assessment Battery (FAB)
Description
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.
Time Frame
baseline
Title
Change in executive functions assessed through Frontal Assessment Battery (FAB)
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Change in executive functions assessed through Frontal Assessment Battery (FAB)
Description
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.
Time Frame
12 weeks after end of intervention
Title
Executive functions assessed through Trail Making Test (TMT)
Description
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.
Time Frame
baseline
Title
Change in executive functions assessed through Trail Making Test (TMT)
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Change in executive functions assessed through Trail Making Test (TMT)
Description
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.
Time Frame
12 weeks after end of intervention
Other Pre-specified Outcome Measures:
Title
Sociodemographic information gathered through the sociodemographic questionnaire
Description
The sociodemographic questionnaire was designed specifically for this study. It gathers information about the participants' gender, age, marital status, educational level, care and support services that the participant attends, medical comorbidities (including cognitive ones), and pharmacological treatment. It will be administered to all participants.
Time Frame
baseline
Title
Adherence to the intervention and dropouts evaluated through a session form
Description
Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, tracking the attendance and mood/behaviour of the participants throughout the intervention sessions.
Time Frame
during the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana I Justo Henriques, PhD
Organizational Affiliation
Nursing School of Coimbra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Óscar Ribeiro, PhD
Organizational Affiliation
Aveiro University
Official's Role
Study Director
Facility Information:
Facility Name
Rsocialform - Geriatria, Lda
City
Mealhada
State/Province
Aveiro
ZIP/Postal Code
3050
Country
Portugal
Facility Name
Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
City
Aveiro
Country
Portugal
Facility Name
Santa Casa da Misericórdia da Horta
City
Açores
Country
Portugal
Facility Name
Centro Social e Cultural S. Pedro de Bairro
City
Braga
Country
Portugal
Facility Name
Centro Social Vale do Homem - Casa da Alegria
City
Braga
Country
Portugal
Facility Name
Santa Casa da Misericórdia de Castro Marim
City
Faro
Country
Portugal
Facility Name
Fundação João Bento Raimundo
City
Guarda
Country
Portugal
Facility Name
Santa Casa da Misericórdia de Alcobaça
City
Leiria
Country
Portugal
Facility Name
Associação de Socorros da Freguesia de Turcifal
City
Lisboa
Country
Portugal
Facility Name
Centro de Apoio Social de Oeiras - IASFA
City
Lisboa
Country
Portugal
Facility Name
Inválidos do Comércio
City
Lisboa
Country
Portugal
Facility Name
Associação de Apoio Social de Perafita
City
Porto
Country
Portugal
Facility Name
Santa Casa da Misericórdia de Coruche
City
Santarém
Country
Portugal
Facility Name
Santa Casa da Misericórdia de Ponte de Lima
City
Viana Do Castelo
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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

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