Mild Cognitive ImpairmentNCT06366867
An Open Platform of Serious Games for Cognitive Intervention
A study testing VibrantMinds in people with Mild Cognitive Impairment and Dementia, run by University of Alberta at 1 site in Canada.
Trial summary
Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Alzheimer Disease
- What is being tested?
- VibrantMinds
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2022to 1 Feb 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
- Older adults aged 65 years and older.
- Cognitive impairment within a specific range as measured by the Mini-Mental State -Examination (MMSE scores between 7 and 25).
- Ability to interact with the Serious Cognitive Games (SCGs) platform, indicating a necessary level of awareness.
- Functional vision and hearing, with or without aids (glasses/hearing aids), to engage with the SCGs platform.
- Functional upper extremity function to interact with the SCGs.
Who cannot join
- Presence of influenza, COVID-19, or another virus that could affect performance or pose a risk to others.
- Inability to communicate or comprehend instructions in English
- Moderate to severe limitations in upper extremity control or movement, significant visual or hearing impairments, or attention deficits that could impact the ability to successfully engage with the SCGs. Participants or their care partners who feel these conditions would interfere with study participation are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.
VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.
Read more
Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.
The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning.
- Conditions
- Mild Cognitive Impairment, Dementia, Alzheimer Disease, Aging
- Being tested
- VibrantMinds
- Keywords
- Serious computer game, computer games, VibrantMinds
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrantMindsDevice
VibrantMindVibrantMinds offers five tablet games targeting cognitive stimulation in older adults: Whack-A-Mole, Word Search, Bejeweled, Mahjong Solitaire, Memory Game, and Glenrose Grocery Game (GGG). These games vary from nostalgic (e.g., Mahjong Solitaire) to leisure-oriented (e.g., Bejeweled), aiming to blend fun with cognitive exercises. Especially designed for ease of use, they cater to older individuals, including those with dementia, gradually increasing in difficulty to match player skill levels. The GGG stands out by integrating game design with everyday cognitive tasks, offering a practical simulation of grocery shopping. Developed with older adult input, VibrantMinds aims to enhance cognitive health in seniors through engaging, meaningful gameplay, supporting its clinical trial's focus on cognitive wellness in the aging.
| Study group | Role | What they receive |
|---|---|---|
| VibrantMinds + Standard Care | Experimental | Older adults at long-term care facilities receive the VibrantMinds games in addition to routine standard care administered by the facility and staff. Receives: Device: VibrantMinds |
| Standard Care | No intervention | Older adults at long-term care facilities receive routine standard care administered by the facility and staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition - Global
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADASCog). Items are generally scored from 1-5; Final scores range 0-70, with higher scores indicating greater severity.
Measured: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Secondary outcomes (5)
Depression
Geriatric Depression Scale (GDS). Each Item is scored 0/1 (no/yes respectively), for a total of 15 questions, and a maximum of 15 points. Higher points indicate greater symptoms of depression.
Measured: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Agitation
Cohen-Mansfield Agitation Inventory (CMAI). The CMAI is a 29 item scale, with each item ranging 1-7. Higher scores indicate greater agitation
Measured: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Occupational Performance
The Canadian Occupational Performance Measure (COPM) employs a 1 to 10 scoring system, where clients rate their performance and satisfaction across chosen activities. A score of 1 indicates poor performance or satisfaction, while a score of 10 signifies excellent outcomes. Changes in these scores over time are used to evaluate the effectiveness of interventions based on client priorities.
Measured: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Engagement
Engagement questionnaire. A developed engagement questionnaire, with items ranked 1-5, will be utilized at each session
Measured: At each session from weeks 0-12; average 2x per week.
Affect
The Positive and Negative Affect Schedule (PANAS) consists of two 10-item mood scales, measuring both positive and negative affect. Respondents rate each item on a scale from 1 (very slightly or not at all) to 5 (extremely), indicating the extent to which they have experienced each emotion. Higher scores represent greater positive or negative affect, respectively.
Measured: At each session from weeks 0-12; average 2x per week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start3 Aug 2022
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will receive VibrantMinds, which consists of sessions with serious computer games in addition to the standard care, whilst the control group will receive the standard of care used at the healthcare facilities.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, CapitalCare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366867
- Sponsor's protocol ID
- Pro00097579
- Status last verified
- May 2026
- First submitted
- 4 Apr 2024
- Last updated
- 12 May 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Platform of Serious Games for Cognitive Intervention
- ClinicalTrials.gov ID
- NCT06366867
- Acronym / sponsor ID
- Pro00097579
- Conditions
- Mild Cognitive Impairment, Dementia, Alzheimer Disease, Aging
- Keywords
- Serious computer game, computer games, VibrantMinds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services, CapitalCare
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 16 Apr 2024 (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.
Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.
VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.
Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.
The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental group will receive VibrantMinds, which consists of sessions with serious computer games in addition to the standard care, whilst the control group will receive the standard of care used at the healthcare facilities.
| Arm | Type | Receives |
|---|---|---|
| VibrantMinds + Standard Care | Experimental | Device: VibrantMindsOlder adults at long-term care facilities receive the VibrantMinds games in addition to routine standard care administered by the facility and staff. |
| Standard Care | No intervention | –Older adults at long-term care facilities receive routine standard care administered by the facility and staff. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Older adults aged 65 years and older.
- Cognitive impairment within a specific range as measured by the Mini-Mental State -Examination (MMSE scores between 7 and 25).
- Ability to interact with the Serious Cognitive Games (SCGs) platform, indicating a necessary level of awareness.
- Functional vision and hearing, with or without aids (glasses/hearing aids), to engage with the SCGs platform.
- Functional upper extremity function to interact with the SCGs.
Key exclusion criteria (3 listed)
- Presence of influenza, COVID-19, or another virus that could affect performance or pose a risk to others.
- Inability to communicate or comprehend instructions in English
- Moderate to severe limitations in upper extremity control or movement, significant visual or hearing impairments, or attention deficits that could impact the ability to successfully engage with the SCGs. Participants or their care partners who feel these conditions would interfere with study participation are excluded.
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 |
|---|---|---|
| VibrantMindsVibrantMindVibrantMinds offers five tablet games targeting cognitive stimulation in older adults: Whack-A-Mole, Word Search, Bejeweled, Mahjong Solitaire, Memory Game, and Glenrose Grocery Game (GGG). These games vary from nostalgic (e.g., Mahjong Solitaire) to leisure-oriented (e.g., Bejeweled), aiming to blend fun with cognitive exercises. Especially designed for ease of use, they cater to older individuals, including those with dementia, gradually increasing in difficulty to match player skill levels. The GGG stands out by integrating game design with everyday cognitive tasks, offering a practical simulation of grocery shopping. Developed with older adult input, VibrantMinds aims to enhance cognitive health in seniors through engaging, meaningful gameplay, supporting its clinical trial's focus on cognitive wellness in the aging. | Device | VibrantMinds + Standard Care |
Primary outcome
Cognition - Global
Time frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADASCog). Items are generally scored from 1-5; Final scores range 0-70, with higher scores indicating greater severity.
5 secondary outcomes
Depression
Time frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Agitation
Time frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Occupational Performance
Time frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Engagement
Time frame: At each session from weeks 0-12; average 2x per week.
Affect
Time frame: At each session from weeks 0-12; average 2x per week.
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 12 May 2026.
- VibrantMinds PlatformLink provided by the sponsor.
- 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.
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 VibrantMinds in people with Mild Cognitive Impairment and Dementia, run by University of Alberta at 1 site in Canada.
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 5 inclusion and 3 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 12 May 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 Canada. 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?
Cognition - Global (time frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)). 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 12 May 2026.