DementiaNCT07041008
Cognitive Stimulation in Older Adults With Alzheimer's Disease
A study testing Digital intervention and Physical/Analogue Intervention in people with Dementia and Neurocognitive Disorders, run by Rsocialform - Geriatria, Lda at 39 sites in Portugal.
Trial summary
This multicentre study, employing a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions that provide care and support services for older adults diagnosed with mild to moderate Alzheimer's disease (AD). 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?
- Digital intervention and Physical/Analogue Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 39 sitesPortugal
- Study dates
- 1 Sep 2025to 13 Mar 2026
- 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 older.
- Receive care/support services for at least three months.
- A diagnosis of probable AD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision.
- Preserved communication skills.
- Native Portuguese speaker.
- Total scores between 10 and 26 points on the Mini Mental State Examination.
Who cannot join
- Cannot read and write.
- Significant sensory or physical limitations.
- Acute or chronic illness preventing participation.
- Severe communication impairment.
- Aggressive or disruptive behaviour.
- Recent initiation (within two months) of neuroleptics, antipsychotics, or other psychoactive medications.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Portugal39 sites
Associação Alzheimer Açores
Açores
Santa Casa da Misericórdia da Horta
Açores
Santa Casa da Misericórdia de Vila do Porto
Açores
CASTIIS
Aveiro
CEDIARA - Associação de Solidariedade Social de Ribeira de Fráguas
Aveiro
Centro Apoio Social Mozelos
Aveiro
Centro Social da Freguesia de Casal Comba
Aveiro
O Jardim - Centro de Solidariedade Social de Canedo
Aveiro
Santa Casa da Misericórdia de Espinho
Aveiro
Santa Casa da Misericórdia de Ovar
Aveiro
Patronato de Santo António - Lar D. José do Patrocínio Dias
Beja
Santa Casa da Misericórdia de Ferreira do Alentejo
Beja
Centro Social do Vale do Homem Casa da Alegria
Braga
Santa Casa da Misericórdia de Mirandela
Bragança
Residência Sénior DON ANTÓNIO - Hilário & Pereira
Castelo Branco
Santa Casa da Misericórdia da Soalheira
Castelo Branco
Santa Casa da Misericórdia de Vila Velha de Rodão
Castelo Branco
Associação Cultural Recreativa e Social de Samuel
Coimbra
Santa Casa da Misericórdia de Montemor-o-Novo
Evora
Santa Casa da Misericórdia de Vila Real de Santo António
Faro
Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau
Funchal, Madeira
Instituto S. João de Deus Funchal
Funchal, Madeira
Fundação João Bento Raimundo
Guarda
Santa Casa da Misericórdia de Figueira de Castelo Rodrigo
Guarda
AMITEI
Leiria, Leria
Santa Casa da Misericórdia de Alcobaça
Leiria
Santa Casa da Misericórdia de Alvaiázere
Leiria
Santa Casa da Misericórdia de Alvorge
Leiria
Associação Casapiana de Solidariedade
Lisbon
Associação de Socorros da Freguesia de Turcifal
Lisbon
Centro Social Paroquial de Moita dos Ferreiros
Lisbon
Santa Casa da Misericórdia de Lisboa - Espaço ComVida
Lisbon
Santa Casa da Misericórdia de Campo Maior
Portalegre
Santa Casa da Misericórdia de Gaia - ERPI José Tavares Bastos
Porto
Quinta de Santa Ana RS
Viana do Castelo
Santa Casa da Misericórdia de Caminha
Viana do Castelo
Santa Casa da Misericórdia de Ponte de Lima
Viana do Castelo
Associação de Solidariedade Social do Alto Paiva
Viseu
Associação de Solidariedade Social e Recreativa de Nespereira
Viseu
About this study
Official title: Digital and Analogical Cognitive Stimulation in Older Adults With Alzheimer's Disease: Effects on Global Cognition, Well-being and Quality of Life Across Distinct Institutional and Sociogeographic Contexts
This multicentre study, employing a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions that provide care and support services for older adults diagnosed with mild to moderate Alzheimer's disease (AD). The primary aim is to evaluate the effects of two distinct cognitive stimulation modalities (digital vs physical/analogue).
The study will assess the impact of individual cognitive stimulation on multiple domains - specifically cognitive function (with an emphasis on memory and executive function), mood, and quality of life - and investigate how institutional and territorial characteristics influence these effects, considering geographical and organisational diversity as potential moderating factors.
Read the detailed description
Population ageing has increased the prevalence of neurodegenerative diseases, with Alzheimer's disease (AD) being the most common form of dementia. Its wide-ranging impact on cognition, emotion, and daily function necessitates person-centred, multidimensional interventions. In Portugal, dementia affects around 9.5% of those aged 65+, underlining its public health relevance and the need for effective responses.
In the absence of a cure, non-pharmacological interventions like cognitive stimulation (CS) have gained prominence. CS is an evidence-based, psychosocial approach involving structured activities that enhance cognitive functions such as memory, language, attention, and reasoning. Broader and more relational than cognitive training or rehabilitation, CS is effective-especially in mild to moderate AD-in improving cognition, mood, and quality of life. Portuguese and international guidelines support its use, with studies showing potential in reducing depression and anxiety in older adults.
Behavioural and psychological symptoms of dementia (BPSD)-including agitation, apathy, aggression, anxiety, and sleep issues-are common in AD and often more disruptive than cognitive decline. These symptoms increase caregiver stress and the likelihood of institutionalisation. CS may alleviate BPSD through emotional engagement and behavioural regulation.
Assessing CS efficacy requires reliable tools. The Mini-Mental State Examination is widely used in Portugal for cognitive screening, while the Alzheimer's Disease Assessment Scale - Cognitive Subscale is often used in clinical trials. As AD notably impairs executive functions, CS targeting these domains can support autonomy and adaptive behaviour.
Contextual factors, such as institutional resources and geographic location, may influence CS outcomes. However, few studies consider these variables, despite their relevance for implementing sustainable, real-world interventions.
This research adopts a multicentre, randomised controlled design to examine two individual CS modalities in older adults with mild to moderate AD attending Portuguese social care services. It aims to assess CS effects on global cognition (particularly executive function and memory), mood, and quality of life, and to explore how institutional and territorial factors shape outcomes.
By combining validated measures, structured protocols, and a context-sensitive approach, the study seeks to support the implementation of effective, sustainable CS interventions within Portugal's care system.
- Conditions
- Dementia, Neurocognitive Disorders, Cognitive Impairment, Cognitive Dysfunction, Cognitive Decline
- Being tested
- Digital intervention, Physical/Analogue Intervention
- Keywords
- older adults, cognitive function, memory, executive function, dementia, cognitive stimulation therapy, cognition, neurocognitive disorders, individual therapy, non-pharmacological therapy, mood, depression, anxiety, quality of life, randomised controlled trial, Alzheimer's disease
- Medical subject headings
- Dementia, Neurocognitive Disorders, Cognitive Dysfunction, Depression, Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital interventionBehavioural
Individual cognitive stimulation sessions will be delivered using RehaCom software, which provides adaptive, computerised exercises targeting specific cognitive domains.
Physical/Analogue InterventionBehavioural
Individual cognitive stimulation sessions will employ structured physical materials, specifically the 'Memories from North to South©' and 'Cognitive Domains' resources, applied on an alternating basis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | Participants in the intervention group 1 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 program in every participant site. Receives: Behavioral: Digital intervention |
| Intervention group 2 | Experimental | Participants in the intervention group 2 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 program in every participant site. Receives: Behavioral: Physical/Analogue Intervention |
| Control group (No intervention) | No intervention | Participants in the control group will receive treatment as usual (TAU) at the site, following the activities specified in their individual care plans. |
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 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: 24 weeks after the baseline
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 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: 24 weeks after the baseline
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 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: 24 weeks after the baseline
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 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: 24 weeks after the baseline
Secondary outcomes (9)
Mood assessed through the Geriatric Depression Scale-15 (GDS-15)
The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.
Measured: Baseline
Change in mood assessed through the GDS-15
The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.
Measured: 12 weeks after the baseline
Change in mood assessed through the GDS-15
The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.
Measured: 24 weeks after the baseline
Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)
It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.
Measured: Baseline
Change in anxiety symptomatology assessed through the GAI
It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.
Measured: 12 weeks after the baseline
Change in anxiety symptomatology assessed through the GAI
It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.
Measured: 24 weeks after the baseline
Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.
Measured: Baseline
Change in quality of life evaluated through QoL-AD
The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.
Measured: 12 weeks after the baseline
Change in quality of life evaluated through QoL-AD
The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.
Measured: 24 weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Sep 2025
- Primary completion13 Sep 2025
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rsocialform - Geriatria, Lda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana I. Justo Henriques, PhD, Principal investigator, Polytechnic University of Beja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041008
- Sponsor's protocol ID
- 13062025
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital and Analogical Cognitive Stimulation in Older Adults With Alzheimer's Disease: Effects on Global Cognition, Well-being and Quality of Life Across Distinct Institutional and Sociogeographic Contexts
- ClinicalTrials.gov ID
- NCT07041008
- Acronym / sponsor ID
- 13062025
- 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
- 514 participants (actual)
- Lead sponsor
- Rsocialform - Geriatria, LdaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 27 Jun 2025 (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, employing a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions that provide care and support services for older adults diagnosed with mild to moderate Alzheimer's disease (AD). The primary aim is to evaluate the effects of two distinct cognitive stimulation modalities (digital vs physical/analogue).
The study will assess the impact of individual cognitive stimulation on multiple domains - specifically cognitive function (with an emphasis on memory and executive function), mood, and quality of life - and investigate how institutional and territorial characteristics influence these effects, considering geographical and organisational diversity as potential moderating factors.
Detailed description
Population ageing has increased the prevalence of neurodegenerative diseases, with Alzheimer's disease (AD) being the most common form of dementia. Its wide-ranging impact on cognition, emotion, and daily function necessitates person-centred, multidimensional interventions. In Portugal, dementia affects around 9.5% of those aged 65+, underlining its public health relevance and the need for effective responses.
In the absence of a cure, non-pharmacological interventions like cognitive stimulation (CS) have gained prominence. CS is an evidence-based, psychosocial approach involving structured activities that enhance cognitive functions such as memory, language, attention, and reasoning. Broader and more relational than cognitive training or rehabilitation, CS is effective-especially in mild to moderate AD-in improving cognition, mood, and quality of life. Portuguese and international guidelines support its use, with studies showing potential in reducing depression and anxiety in older adults.
Behavioural and psychological symptoms of dementia (BPSD)-including agitation, apathy, aggression, anxiety, and sleep issues-are common in AD and often more disruptive than cognitive decline. These symptoms increase caregiver stress and the likelihood of institutionalisation. CS may alleviate BPSD through emotional engagement and behavioural regulation.
Assessing CS efficacy requires reliable tools. The Mini-Mental State Examination is widely used in Portugal for cognitive screening, while the Alzheimer's Disease Assessment Scale - Cognitive Subscale is often used in clinical trials. As AD notably impairs executive functions, CS targeting these domains can support autonomy and adaptive behaviour.
Contextual factors, such as institutional resources and geographic location, may influence CS outcomes. However, few studies consider these variables, despite their relevance for implementing sustainable, real-world interventions.
This research adopts a multicentre, randomised controlled design to examine two individual CS modalities in older adults with mild to moderate AD attending Portuguese social care services. It aims to assess CS effects on global cognition (particularly executive function and memory), mood, and quality of life, and to explore how institutional and territorial factors shape outcomes.
By combining validated measures, structured protocols, and a context-sensitive approach, the study seeks to support the implementation of effective, sustainable CS interventions within Portugal's care system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Behavioral: Digital interventionParticipants in the intervention group 1 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 program in every participant site. |
| Intervention group 2 | Experimental | Behavioral: Physical/Analogue InterventionParticipants in the intervention group 2 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 program in every participant site. |
| Control group (No intervention) | No intervention | –Participants in the control group will receive treatment as usual (TAU) at the site, following the activities specified in their individual care plans. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 or older.
- Receive care/support services for at least three months.
- A diagnosis of probable AD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision.
- Preserved communication skills.
- Native Portuguese speaker.
Key exclusion criteria (6 listed)
- Cannot read and write.
- Significant sensory or physical limitations.
- Acute or chronic illness preventing participation.
- Severe communication impairment.
- Aggressive or disruptive behaviour.
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 |
|---|---|---|
| Digital interventionIndividual cognitive stimulation sessions will be delivered using RehaCom software, which provides adaptive, computerised exercises targeting specific cognitive domains. | Behavioural | Intervention group 1 |
| Physical/Analogue InterventionIndividual cognitive stimulation sessions will employ structured physical materials, specifically the 'Memories from North to South©' and 'Cognitive Domains' resources, applied on an alternating basis. | Behavioural | Intervention group 2 |
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 baseline
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: 24 weeks after the baseline
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 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: 24 weeks after the 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.
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 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: 24 weeks after the 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.
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 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: 24 weeks after the 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.
9 secondary outcomes
Mood assessed through the Geriatric Depression Scale-15 (GDS-15)
Time frame: Baseline
Change in mood assessed through the GDS-15
Time frame: 12 weeks after the baseline
Change in mood assessed through the GDS-15
Time frame: 24 weeks after the baseline
Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)
Time frame: Baseline
Change in anxiety symptomatology assessed through the GAI
Time frame: 12 weeks after the baseline
Change in anxiety symptomatology assessed through the GAI
Time frame: 24 weeks after the baseline
Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)
Time frame: Baseline
Change in quality of life evaluated through QoL-AD
Time frame: 12 weeks after the baseline
Change in quality of life evaluated through QoL-AD
Time frame: 24 weeks after the baseline
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 25 Mar 2026.
- 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
Polytechnic University of Beja
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention and Physical/Analogue Intervention in people with Dementia and Neurocognitive Disorders, run by Rsocialform - Geriatria, Lda at 39 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 6 inclusion and 6 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.