Mild Cognitive ImpairmentNCT04920123
Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
A study testing Neuro-World in people with Mild Cognitive Impairment, run by University of Massachusetts, Amherst at 2 sites in United States.
Trial summary
This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Neuro-World
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seventeen points or greater and smaller than twenty-six points on the Montreal Cognitive Assessment (MoCA)
- Fifty-five years old and above
- Minimal technological literacy (i.e. ability to use a tablet independently)
- Having a computer for online videoconferencing-based communication (necessary for online cognitive assessments)
Who cannot join
- Confounding neurological and psychiatric disorders
- History of traumatic brain injury
- Clinically known hearing or vision impairment
- Severe upper-limb motor impairments that could impact the use of mobile devices
- Clinical presentations suggestive of dementia with Lewy bodies, progressive supranuclear palsy, multiple system atrophy, or vascular parkinsonism
- Diagnosis of dementia
Show all 9Show fewer
- Major depression
- Any significant upper-limb impairment that could affect tablet use
- Participation in any other therapist-supervised cognitive training
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Massachusetts, Amherst
Amherst, Massachusetts, 01003
The State University of New Jersey, Rutgers
Newark, New Jersey, 07102
About this study
Official title: Towards the Development of a Mobile-health Technology Designed to Encourage the Use of Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment.
Read the detailed description
This study will be a cross-over randomized controlled trial.
Fifty participants will be enrolled and randomly assigned to group A or group B.
Group A will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week for 12 weeks in the home setting (i.e., intervention period). For the following 12 weeks, the participants will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period).
Group B will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period). For the following 12 weeks, the participants will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week in the home setting (i.e., intervention period).
All the participants in both groups will receive phone calls twice a week to 1) provide feedback on their adherence to Neuro-World cognitive training (during the intervention period) and 2) learn any significant changes in the level of their daily activities (during the no-intervention period and the intervention period).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Neuro-World
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-WorldDevice
Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention.
| Study group | Role | What they receive |
|---|---|---|
| Game Intervention | Experimental | Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times). Receives: Device: Neuro-World |
| No Intervention | No intervention | Study participants do not engage in any cognitive training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment (MoCA)
MoCA scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MoCA scores was measured from baseline to 12 weeks
Measured: 12 weeks
Secondary outcomes (6)
Change in Mini-Mental State Examination (MMSE)
MMSE scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MMSE scores was measured from baseline to 12 weeks
Measured: 12 weeks
Change in Digit Forward Span (DFS)
DFS scores range between 0 and 14. Higher scores indicate better cognitive function. The change in DFS scores was measured from baseline to 12 weeks
Measured: 12 weeks
Change in Digit Backward Span (DBS)
DBS scores range between 0 and 14. Higher scores indicate better cognitive function. The change in DBS scores was measured from baseline to 12 weeks
Measured: 12 weeks
Change in Geriatric Depression Scale (GDS)
GDS scores range between 0 and 15. Higher scores indicate more severe depression. The change in GDS scores was measured from baseline to 12 weeks
Measured: 12 weeks
Change in Short Form 36 (SF-36) Mental Component Summary Score
SF-36 consists of eight health domains, each scored from 0 to 100, with higher scores indicating more favorable health states. In this study, we report the Mental Component Summary (MCS) score, a norm-based composite score derived from relevant mental health domains. The MCS is standardized to a mean of 50 (SD = 10) in the general U.S. population, where higher scores reflect better mental well-being. The change in SF-36 MCS scores was measured from baseline to 12 weeks.
Measured: 12 weeks
Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)
IADL scores range between 0 and 8. Higher scores indicate greater levels of performance in activities of daily living. The change in IADL scores was measured from baseline to 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start17 Feb 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers, The State University of New Jersey, Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Sunghoon I Lee, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920123
- Sponsor's protocol ID
- 2585
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2021
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards the Development of a Mobile-health Technology Designed to Encourage the Use of Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
- ClinicalTrials.gov ID
- NCT04920123
- Acronym / sponsor ID
- 2585
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- Rutgers, The State University of New Jersey, Université de Montréal
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment.
Detailed description
This study will be a cross-over randomized controlled trial.
Fifty participants will be enrolled and randomly assigned to group A or group B.
Group A will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week for 12 weeks in the home setting (i.e., intervention period). For the following 12 weeks, the participants will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period).
Group B will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period). For the following 12 weeks, the participants will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week in the home setting (i.e., intervention period).
All the participants in both groups will receive phone calls twice a week to 1) provide feedback on their adherence to Neuro-World cognitive training (during the intervention period) and 2) learn any significant changes in the level of their daily activities (during the no-intervention period and the intervention period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game Intervention | Experimental | Device: Neuro-WorldStudy participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times). |
| No Intervention | No intervention | –Study participants do not engage in any cognitive training. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Seventeen points or greater and smaller than twenty-six points on the Montreal Cognitive Assessment (MoCA)
- Fifty-five years old and above
- Minimal technological literacy (i.e. ability to use a tablet independently)
- Having a computer for online videoconferencing-based communication (necessary for online cognitive assessments)
Key exclusion criteria (9 listed)
- Confounding neurological and psychiatric disorders
- History of traumatic brain injury
- Clinically known hearing or vision impairment
- Severe upper-limb motor impairments that could impact the use of mobile devices
- Clinical presentations suggestive of dementia with Lewy bodies, progressive supranuclear palsy, multiple system atrophy, or vascular parkinsonism
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 |
|---|---|---|
| Neuro-WorldNeuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention. | Device | Game Intervention |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA)
Time frame: 12 weeks
MoCA scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MoCA scores was measured from baseline to 12 weeks
6 secondary outcomes
Change in Mini-Mental State Examination (MMSE)
Time frame: 12 weeks
Change in Digit Forward Span (DFS)
Time frame: 12 weeks
Change in Digit Backward Span (DBS)
Time frame: 12 weeks
Change in Geriatric Depression Scale (GDS)
Time frame: 12 weeks
Change in Short Form 36 (SF-36) Mental Component Summary Score
Time frame: 12 weeks
Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sunghoon I Lee, PhD principal investigator
University of Massachusetts, Amherst
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-World in people with Mild Cognitive Impairment, run by University of Massachusetts, Amherst at 2 sites 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 4 inclusion and 9 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 7 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 2 sites 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?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Montreal Cognitive Assessment (MoCA) (time frame: 12 weeks). 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 7 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.