DementiaNCT07272746
Effects of a Social Robot Cognitive-Game Intervention in Older Adults With Mild Cognitive Impairment and Dementia
A study testing interactive robot game in people with Dementia and Mild Cognitive Impairment (MCI), run by Taipei Medical University.
Trial summary
This study aims to evaluate the effects of interactive robot-based games on cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Dementia, Mild Cognitive Impairment (MCI)
- What is being tested?
- interactive robot game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 years or older
- Diagnosed by a physician with Mild Cognitive Impairment, mild, or moderate dementia
- Able to communicate in Mandarin or Taiwanese
- Willing to participate and provides informed consent signed by the participant or their family member/legal representative
Who cannot join
- Individuals who experience fear or aversion toward interactive robots or related equipment
- Individuals with severe hearing or visual impairments that affect participation in activities
- Individuals unable to complete the entire intervention due to unstable physical or mental conditions
- Individuals deemed unsuitable for this study by physician assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the effects of interactive robot-based games on cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group; the experimental group will participate in robot games for 12 weeks, while the control group will receive routine care. Data will be collected via questionnaires to investigate whether robot games can improve cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia.
Read the detailed description
This study aims to evaluate the effects of interactive robot games on cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group. The experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session, while the control group will receive usual care. All participants will complete four questionnaire assessments to investigate whether the robot games can improve cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia.
- Conditions
- Dementia, Mild Cognitive Impairment (MCI)
- Being tested
- interactive robot game
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive robot gameOther
The experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| interactive robot game | Experimental | The experimental group will participate in a 12-week interactive robot game. The interactive robot is a screen-based robot, with the main interaction area being a facial display. Receives: Other: interactive robot game |
| Routine care | No intervention | The control group will receive routine care and will not undergo any specific interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment(MoCA)
MoCA is one of the primary assessment indicators that investigators expect to see improved after interactive robot game interventions. The MoCA assessment covers multiple cognitive domains including attention and concentration, executive function, memory, language ability, visuospatial skills, abstract thinking, calculation ability, and orientation. The full score is 30 points, with higher scores indicating better cognitive function.
Measured: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
Neuropsychiatric Inventory Questionnaire(NPI-Q)
NPI-Q is one of the primary evaluation indicators investigators expect to improve after interactive robot game intervention.
NPI-Q includes 12 items: delusions, hallucinations, agitation, depression, anxiety, abnormal motor behavior, sleep and nighttime behavior disorders, etc. Each item is scored for severity on a scale of 1-3 points, with higher scores indicating greater severity, and for caregiver distress on a scale of 0-5 points, with higher scores indicating greater distress. The total score is calculated by multiplying the severity and distress scores, with higher scores representing more severe symptoms.
Measured: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
Secondary outcomes (2)
Quality of Life in Alzheimer's Disease(QoL-AD)
Quality of life is one of the secondary outcome measures that investigators expect to improve after an interactive robot game intervention. The QoL-AD scale is rated by the person with dementia and their caregiver on a four-point scale (poor, fair, good, very good) for each item, with total scores ranging from 13 to 52 points, where higher scores indicate better quality of life.
Measured: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
Geriatric Depression Scale 15(GDS-15)
The Geriatric Depression Scale-15 (GDS-15) is one of the secondary evaluation indicators that investigators hope will show improvement after an interactive robot game intervention. The GDS-15 is a self-administered assessment scale containing 15 items, with a total score ranging from 0 to 15 points, where higher scores indicate a greater tendency toward depression.
Measured: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272746
- Sponsor's protocol ID
- N202504063
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Social Robot Cognitive-Game Intervention in Older Adults With Mild Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT07272746
- Acronym / sponsor ID
- N202504063
- Conditions
- Dementia, Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Dec 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 study aims to evaluate the effects of interactive robot-based games on cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group; the experimental group will participate in robot games for 12 weeks, while the control group will receive routine care. Data will be collected via questionnaires to investigate whether robot games can improve cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia.
Detailed description
This study aims to evaluate the effects of interactive robot games on cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group. The experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session, while the control group will receive usual care. All participants will complete four questionnaire assessments to investigate whether the robot games can improve cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interactive robot game | Experimental | Other: interactive robot gameThe experimental group will participate in a 12-week interactive robot game. The interactive robot is a screen-based robot, with the main interaction area being a facial display. |
| Routine care | No intervention | –The control group will receive routine care and will not undergo any specific interventions |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 50 years or older
- Diagnosed by a physician with Mild Cognitive Impairment, mild, or moderate dementia
- Able to communicate in Mandarin or Taiwanese
- Willing to participate and provides informed consent signed by the participant or their family member/legal representative
Key exclusion criteria (4 listed)
- Individuals who experience fear or aversion toward interactive robots or related equipment
- Individuals with severe hearing or visual impairments that affect participation in activities
- Individuals unable to complete the entire intervention due to unstable physical or mental conditions
- Individuals deemed unsuitable for this study by physician assessment
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 |
|---|---|---|
| interactive robot gameThe experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session | Other | interactive robot game |
Primary outcome
Montreal Cognitive Assessment(MoCA)
Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
MoCA is one of the primary assessment indicators that investigators expect to see improved after interactive robot game interventions. The MoCA assessment covers multiple cognitive domains including attention and concentration, executive function, memory, language ability, visuospatial skills, abstract thinking, calculation ability, and orientation. The full score is 30 points, with higher scores indicating better cognitive function.
Neuropsychiatric Inventory Questionnaire(NPI-Q)
Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
NPI-Q is one of the primary evaluation indicators investigators expect to improve after interactive robot game intervention. NPI-Q includes 12 items: delusions, hallucinations, agitation, depression, anxiety, abnormal motor behavior, sleep and nighttime behavior disorders, etc. Each item is scored for severity on a scale of 1-3 points, with higher scores indicating greater severity, and for caregiver distress on a scale of 0-5 points, with higher scores indicating greater distress. The total score is calculated by multiplying the severity and distress scores, with higher scores representing more severe symptoms.
2 secondary outcomes
Quality of Life in Alzheimer's Disease(QoL-AD)
Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
Geriatric Depression Scale 15(GDS-15)
Time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing interactive robot game in people with Dementia and Mild Cognitive Impairment (MCI), run by Taipei Medical University.
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 4 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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorothy Bai, PhD (+886-2-27361661 ext. 6332, dbai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment(MoCA) (time frame: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.). The study lists 2 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 9 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.