- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433493
Effect of Individual Cognitive Stimulation on Memory and Executive Function in Older Adults With Alzheimer's Disease
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susana I Justo Henriques, PhD
- Phone Number: +351231202040
- Email: susana.justo.henriques@gmail.com
Study Contact Backup
- Name: Rui PC Maia, Bs
- Phone Number: +351967116708
- Email: geral@replicar.pt
Study Locations
-
-
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Aveiro, Portugal
- Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
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Açores, Portugal
- Santa Casa da Misericórdia da Horta
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Braga, Portugal
- Centro Social e Cultural S. Pedro de Bairro
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Braga, Portugal
- Centro Social Vale do Homem - Casa da Alegria
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Faro, Portugal
- Santa Casa da Misericórdia de Castro Marim
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Guarda, Portugal
- Fundação João Bento Raimundo
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Leiria, Portugal
- Santa Casa da Misericórdia de Alcobaça
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Lisboa, Portugal
- Associação de Socorros da Freguesia de Turcifal
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Lisboa, Portugal
- Centro de Apoio Social de Oeiras - IASFA
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Lisboa, Portugal
- Inválidos do Comércio
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Porto, Portugal
- Associação de Apoio Social de Perafita
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Santarém, Portugal
- Santa Casa da Misericórdia de Coruche
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Viana Do Castelo, Portugal
- Santa Casa da Misericórdia de Ponte de Lima
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Aveiro
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Mealhada, Aveiro, Portugal, 3050
- Rsocialform - Geriatria, Lda
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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. |
No Intervention: Control group
Participants in the control group will receive treatment/activities as usual, participating in the activities previously established in their individual intervention plan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
Time Frame: baseline
|
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)
Time Frame: 12 weeks after the beginning of the intervention
|
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)
Time Frame: 12 weeks after end of intervention
|
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)
Time Frame: baseline
|
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)
Time Frame: 12 weeks after the beginning of the intervention
|
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)
Time Frame: 12 weeks after end of intervention
|
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)
Time Frame: baseline
|
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)
Time Frame: 12 weeks after the beginning of the intervention
|
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)
Time Frame: 12 weeks after end of intervention
|
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)
Time Frame: baseline
|
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)
Time Frame: 12 weeks after the beginning of the intervention
|
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)
Time Frame: 12 weeks after end of intervention
|
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)
Time Frame: baseline
|
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)
Time Frame: 12 weeks after the beginning of the intervention
|
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)
Time Frame: 12 weeks after end of intervention
|
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)
Time Frame: baseline
|
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)
Time Frame: 12 weeks after the beginning of the intervention
|
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)
Time Frame: 12 weeks after end of intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic information gathered through the sociodemographic questionnaire
Time Frame: baseline
|
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.
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baseline
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Adherence to the intervention and dropouts evaluated through a session form
Time Frame: during the intervention
|
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.
|
during the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susana I Justo Henriques, PhD, Nursing School of Coimbra
- Study Director: Óscar Ribeiro, PhD, Aveiro University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220621
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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