DementiaPLwDNCT07541144
Group Digital Gaming: Experiences of Older Adults Living With Dementia in an Activity for Cognitive Impairment
A study testing Group-Based Digital Gaming in people with Dementia, run by George Mason University at 1 site in United States.
Trial summary
The study examines the effects of a group digital gaming intervention on cognitive function, mood, and behaviors in people with early to moderate levels of dementia, using Obie Technology by employing a pretest and posttest design with a mixed methods approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Group-Based Digital Gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The study examines the effects of a group digital gaming intervention on cognitive function, mood, and behaviors in people with early to moderate levels of dementia, using Obie Technology by employing a pretest and posttest design with a mixed methods approach.
- Conditions
- Dementia
- Being tested
- Group-Based Digital Gaming
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-Based Digital GamingBehavioural
The interactive digital gaming activity is delivered using Obie Technology. Various games are projected onto the table's surface, and participants interacted with them by "touching" the images with their hands. The system included sensors that detected hand movements, making the activity fully interactive. More than 200 games are available. Some examples of the popular games include Mahjong, in which participants match identical tiles by touching them, and Around the World, in which participants identify the correct objects based on the country's flag, such as selecting a double-decker London bus for the United Kingdom. For many games, difficulty levels are adjustable, which is especially useful for games that involves math. Games are chosen based on participants' requests as well as facilitators' recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Group-Based Digital Gaming | Experimental | Not described Receives: Behavioral: Group-Based Digital Gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA):
Montreal Cognitive Assessment contains 30 items and takes approximately 10 minutes to administer assessing multiple cognitive domains such as short-term memory, visuospatial abilities, and abstraction. The minimum total score is 0 and the maximum tota score is 30. The higher scores are associated with better cognitive function, and a score of 26 and higher is considered normal.
Measured: Before the intervention (baseline), at the end of week 10, and at the end of the intervention (after 20 weeks of the study).
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Neuropsychiatric Inventory Questionnaire is an informant-based instrument that assesses the possible presence of 12 neuropsychiatric symptoms in dementia, including delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, night-time behavioral disturbances and appetite/eating disturbances. It asks the presence each symptom and its severity with a 3-point scale. The minimum total score is 0, and the maximum total score is 36. Higher scores indicate more severe neuropsychiatric symptoms and/or greater caregiver distress. It is shown to be a reliable and valid instrument. Most informants will be able to complete this instrument in less than five minutes.
Measured: Before the intervention (baseline), at the end of week 10, and at the end of the intervention (after 20 weeks of the study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Aug 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megumi Inoue, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541144
- Sponsor's protocol ID
- 2017929
- Other IDs
- 224407P
- Acronym
- PLwD
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 15 Sep 2026
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Digital Gaming: Experiences of Older Adults Living With Dementia in an Activity for Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07541144
- Acronym / sponsor ID
- PLwD / 2017929
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Apr 2026 (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.
The study examines the effects of a group digital gaming intervention on cognitive function, mood, and behaviors in people with early to moderate levels of dementia, using Obie Technology by employing a pretest and posttest design with a mixed methods approach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group-Based Digital Gaming | Experimental | Behavioral: Group-Based Digital Gaming |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Group-Based Digital GamingThe interactive digital gaming activity is delivered using Obie Technology. Various games are projected onto the table's surface, and participants interacted with them by "touching" the images with their hands. The system included sensors that detected hand movements, making the activity fully interactive. More than 200 games are available. Some examples of the popular games include Mahjong, in which participants match identical tiles by touching them, and Around the World, in which participants identify the correct objects based on the country's flag, such as selecting a double-decker London bus for the United Kingdom. For many games, difficulty levels are adjustable, which is especially useful for games that involves math. Games are chosen based on participants' requests as well as facilitators' recommendations. | Behavioural | Group-Based Digital Gaming |
Primary outcome
Montreal Cognitive Assessment (MoCA):
Time frame: Before the intervention (baseline), at the end of week 10, and at the end of the intervention (after 20 weeks of the study).
Montreal Cognitive Assessment contains 30 items and takes approximately 10 minutes to administer assessing multiple cognitive domains such as short-term memory, visuospatial abilities, and abstraction. The minimum total score is 0 and the maximum tota score is 30. The higher scores are associated with better cognitive function, and a score of 26 and higher is considered normal.
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: Before the intervention (baseline), at the end of week 10, and at the end of the intervention (after 20 weeks of the study).
Neuropsychiatric Inventory Questionnaire is an informant-based instrument that assesses the possible presence of 12 neuropsychiatric symptoms in dementia, including delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, night-time behavioral disturbances and appetite/eating disturbances. It asks the presence each symptom and its severity with a 3-point scale. The minimum total score is 0, and the maximum total score is 36. Higher scores indicate more severe neuropsychiatric symptoms and/or greater caregiver distress. It is shown to be a reliable and valid instrument. Most informants will be able to complete this instrument in less than five minutes.
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 15 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-Based Digital Gaming in people with Dementia, run by George Mason University at 1 site in United States.
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 0 inclusion and 1 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Montreal Cognitive Assessment (MoCA): (time frame: Before the intervention (baseline), at the end of week 10, and at the end of the intervention (after 20 weeks of the study).). 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 15 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.