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Mild Cognitive Impairment (MCI)NCT07137650

A Game-based Screening for MCI Detection in Older Adults

An observational study of Mild Cognitive Impairment (MCI), run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research explores a new and engaging way to screen for mild cognitive impairment (MCI) in older adults using a computer game instead of traditional paper-based tests. MCI is an early sign of cognitive decline and can lead to dementia. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment (MCI)
How many people
59 participants
Where
1 siteCanada
Study dates
15 May 2025to 15 May 2025
Phase
Observational
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
  • Healthy volunteers accepted
  • Older adult

Study population: Older adults who are 65 and older with and without mild cognitive impairment

Who may be able to join

  • Older adults who are aged 65 and above with typical cognition or MCI as reported by themselves, or a health care professional.
  • Older adults participating in this study must have MoCA score of 18 or higher.
  • Older adults participating in the study must have functional vision and hearing, with or without aids such as glasses or hearing aids that enable them to interact with the game and comprehend the instructions. As part of the study recruitment activities, the researcher will explain the tasks required and discuss the vision and hearing demands.
  • Older adults participating in the study must be capable of communicating and comprehending assessments, instructions, and simple sentences in English, as communication and comprehension is essential for interacting effectively with game components and the researcher. To assess their communication, reading, and comprehension skills, the researcher will provide participants with a few sentences in English related to the game content. Participants will be asked to read these sentences aloud and explain the meaning of the sentence to confirm their ability to read and understand the content.
  • Older adults participating in the study must have adequate upper extremity function to play the game, using a mouse and do paper-and-pencil based measurements, using a pencil. During the study's introduction and training part of the game, potential participants can report any physical limitations. The researcher will also screen for these

Who cannot join

  • Older adults currently suffering from Influenza, COVID-19, or any other viral illness at the time of data collection that could impair their performance will be excluded. These conditions could impair their performance, potentially affecting the reliability of the outcomes. Additionally, the presence of such illnesses could pose a health risk to other participants who use the same equipment, as well as to the researcher.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta

    Edmonton, Alberta, T6G 2G4

Other trials in Canada

About this study

Official title: A Game-based Screening for Mild Cognitive Impairment Detection in Older Adults

This research explores a new and engaging way to screen for mild cognitive impairment (MCI) in older adults using a computer game instead of traditional paper-based tests. MCI is an early sign of cognitive decline and can lead to dementia. Detecting it early is important, but current methods are not always accessible, enjoyable, or reflective of real-life tasks.

The study will test the Glenrose Grocery Game (G3), a computer game simulating a real-life shopping trip. The game challenges memory, attention, and problem-solving in a familiar, interactive setting. Originally developed for cognitive training in older adults, this is the first time it is being tested as a screening tool for cognitive issues.

Read more

Fifty-nine older adults (aged 65+) will be recruited, with and without signs of MCI. Each participant will attend a single 90-minute session. They will provide consent, complete demographic questions, and undergo two standard cognitive tests: the Montreal Cognitive Assessment (MoCA) and Quick Mild Cognitive Impairment screen (Qmci). Anxiety will be measured before and after the cognitive tasks. Participants will then play six levels of the G3 game and complete a usability questionnaire.

The study will measure game performance (e.g., time taken, errors, and budget management), cognitive test scores, anxiety levels before and after gameplay, and usability ratings.

The G3 game could provide a less stressful, more realistic, and more accessible method to screen for memory problems, potentially enabling earlier detection. It may be especially helpful for people with limited access to trained clinicians or those who feel anxious during traditional tests. Risks are minimal, similar to daily activities, such as feeling tired or briefly anxious. Participants may stop at any time. All data will be kept private and secure, with names replaced by ID numbers.

Read the detailed description

Eligibility: Adults aged 65+ with typical cognition or mild concerns, with adequate vision, hearing, and ability to use a mouse, and able to understand English and give consent.

Locations: Community centres, long-term care homes, the University of Alberta, or participants' homes.

Recruitment: Social media, posters, word of mouth, and community presentations. Benefits: No direct benefit, but participants may enjoy the game and contribute to testing a potentially more user-friendly screening method for older adults.

Medical subject headings
Cognitive Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Montreal Cognitive Assessment (MoCA)

    1. A standard cognitive screening tool to assess general cognitive abilities. Range: 0-30 interpretation: Higher scores indicate better cognitive performance.
    2. A brief screening test to detect early cognitive impairment.
    3. Task completion, Time of playing, Number of correct and errors, using aid,..
    4. System usability scale to measure the participants' experience with the game
    5. State and train anxiety of the participants

    Measured: Time Frame: Administered once during the 90-minute session. The administration of this test takes 10-15 minutes

  2. Quick Mild Cognitive Impairment screen (Qmci)

    Description: A brief screening instrument for early detection of mild cognitive impairment.

    Range: 0-100 points. Range: 0-100 points.

    Interpretation: Higher scores indicate better cognitive performance. Interpretation: Higher scores indicate better cognitive performance.

    Measured: Time Frame: Administered once during the 90-minute session.The administration of this test takes 10-15 minutes

  3. Game Performance Measures from the Glenrose Grocery Game (G3)

    Description: Objective in-game performance metrics including task completion status, total play time, number of correct responses, number of errors, and use of in-game aids. Score Range: Variable depending on the specific metric (e.g., errors = 0 to maximum possible errors per stage).

    Interpretation: Higher accuracy and fewer errors indicate better cognitive performance.

    Measured: Time Frame: Collected continuously during gameplay within the 90-minute session. Gameplay usually takes 30 minutes.

Secondary outcomes (2)
  1. System Usability Scale (SUS) System Usability Scale (SUS) System Usability Scale (SUS)

    Description: A validated 10-item questionnaire assessing participants' perceived usability of the G3 game.

    Score Range: 0-100 points.

    Interpretation: Higher scores indicate better usability.

    Measured: Time Frame: Administered immediately after gameplay during the same 90-minute session. It takes 5 minutes to do this self-adminstred test.

  2. State-Trait Anxiety Inventory (STAI)

    Description: A standardized measure of participants' temporary (state) and general (trait) anxiety levels.

    Score Range: 20-80 points for each subscale.

    Interpretation: Higher scores indicate greater anxiety.

    Measured: Time Frame: Administered before and after gameplay during the same 90-minute session. Doin the test takes aorund 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start15 May 2025
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137650
Sponsor's protocol ID
Pro00142237
Status last verified
Aug 2025
First submitted
6 Aug 2025
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zygouris S, Iliadou P, Lazarou E, Giakoumis D, Votis K, Alexiadis A, Triantafyllidis A, Segkouli S, Tzovaras D, Tsiatsos T, Papagianopoulos S, Tsolaki M. Detection of Mild Cognitive Impairment in an At-Risk Group of Older Adults: Can a Novel Self-Administered Serious Game-Based Screening Test Improve Diagnostic Accuracy? J Alzheimers Dis. 2020;78(1):405-412. doi: 10.3233/JAD-200880.

    PubMed 32986676

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment (MCI), 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 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 22 Aug 2025. 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?

1. Montreal Cognitive Assessment (MoCA) (time frame: Time Frame: Administered once during the 90-minute session. The administration of this test takes 10-15 minutes). The study lists 3 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 NCT07137650, which also lists 1 linked publication.

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 22 Aug 2025.

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