DementiaNCT05433493
Effect of Individual Cognitive Stimulation on Memory and Executive Function in Older Adults With Alzheimer's Disease
A study testing Cognitive stimulation in people with Dementia and Neurocognitive Disorders, run by Rsocialform - Geriatria, Lda at 14 sites in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Neurocognitive Disorders, Cognitive Impairment
- What is being tested?
- Cognitive stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 14 sitesPortugal
- Study dates
- 1 Jul 2022to 6 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Portugal14 sites
Santa Casa da Misericórdia da Horta
Açores
Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
Aveiro
Centro Social e Cultural S. Pedro de Bairro
Braga
Centro Social Vale do Homem - Casa da Alegria
Braga
Santa Casa da Misericórdia de Castro Marim
Faro
Fundação João Bento Raimundo
Guarda
Santa Casa da Misericórdia de Alcobaça
Leiria
Associação de Socorros da Freguesia de Turcifal
Lisbon
Centro de Apoio Social de Oeiras - IASFA
Lisbon
Inválidos do Comércio
Lisbon
Rsocialform - Geriatria, Lda
Mealhada, Aveiro District, 3050
Associação de Apoio Social de Perafita
Porto
Santa Casa da Misericórdia de Coruche
Santarém
Santa Casa da Misericórdia de Ponte de Lima
Viana do Castelo
About this study
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
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.
Read the 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
- Being tested
- Cognitive stimulation
- 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
- Medical subject headings
- Dementia, Neurocognitive Disorders, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Jul 2022
- Primary completion31 Mar 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rsocialform - Geriatria, Lda
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University
- Responsible party
- Sponsor
- Investigators
- Susana I Justo Henriques, PhD, Principal investigator, Nursing School of CoimbraÓscar Ribeiro, PhD, Study director, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433493
- Sponsor's protocol ID
- 20220621
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Justo-Henriques SI, Silva RCG, Carvalho JO, Perez-Saez E, de Sao Joao RMV, Ribeiro O. Differential response to cognitive stimulation in moderate versus moderately severe Alzheimer's disease. Can J Exp Psychol. 2026 Jun;80(2):143-157. doi: 10.1037/cep0000395. Epub 2026 Feb 5.
PubMed 41642798Justo-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.
PubMed 41139428
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05433493
- Acronym / sponsor ID
- 20220621
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Rsocialform - Geriatria, LdaUniversity, hospital or other
- Collaborators
- Aveiro University
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cognitive stimulationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive stimulationThe 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Derived from this study: PubMed 41642798Justo-Henriques SI, Silva RCG, Carvalho JO, Perez-Saez E, de Sao Joao RMV, Ribeiro O. Differential response to cognitive stimulation in moderate versus moderately severe Alzheimer's disease. Can J Exp Psychol. 2026 Jun;80(2):143-157. doi: 10.1037/cep0000395. Epub 2026 Feb 5.
- Derived from this study: PubMed 41139428Justo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana I Justo Henriques, PhD principal investigator
Nursing School of Coimbra
Óscar Ribeiro, PhD study director
Aveiro University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation in people with Dementia and Neurocognitive Disorders, run by Rsocialform - Geriatria, Lda at 14 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functioning assessed through Mini-Mental State Examination (MMSE) (time frame: baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433493, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.