Trial Outcomes & Findings for Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic (NCT NCT04920123)

NCT ID: NCT04920123

Last Updated: 2025-08-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-08-07

Participant Flow

Participants were recruited remotely across the United States and Canada through email, phone, and social media. Of the 155 individuals contacted, 41 were screened for eligibility via videoconference. Fifteen met inclusion criteria and were enrolled in the study. Three participants later discontinued participation.

Fifteen participants were enrolled and randomized into two groups. Three participants discontinued participation during the study. No significant events such as washout or run-in periods occurred prior to group assignment. Four caregivers were enrolled to assist with technical arrangements and help manage study logistics. Two caregivers discontinued participation during the study after the participants they were assisting withdrew.

Participant milestones

Measure	Group A: Intervention, Then Non-intervention Group A will self-administer Neuro-World cognitive training games for 30 minutes per day, twice a week, for 12 weeks in a home setting (intervention period). This will be followed by 12 weeks without any therapist-supervised cognitive therapies (non-intervention period).	Group B: Non-intervention, Then Intervention Group B will first complete a 12-week non-intervention period without therapist-supervised cognitive therapies. This will be followed by 12 weeks of self-administered Neuro-World cognitive training games for 30 minutes per day, twice a week, in a home setting (intervention period).	Caregivers Caregivers are optionally enrolled to assist with technical arrangements and help manage study logistics. No interventions are administered to the caregiver group.
First Intervention (12 Weeks) STARTED	8	7	4
First Intervention (12 Weeks) COMPLETED	6	6	2
First Intervention (12 Weeks) NOT COMPLETED	2	1	2
Second Intervention (12 Weeks) STARTED	6	6	2
Second Intervention (12 Weeks) COMPLETED	6	6	2
Second Intervention (12 Weeks) NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Group A: Intervention, Then Non-intervention Group A will self-administer Neuro-World cognitive training games for 30 minutes per day, twice a week, for 12 weeks in a home setting (intervention period). This will be followed by 12 weeks without any therapist-supervised cognitive therapies (non-intervention period).	Group B: Non-intervention, Then Intervention Group B will first complete a 12-week non-intervention period without therapist-supervised cognitive therapies. This will be followed by 12 weeks of self-administered Neuro-World cognitive training games for 30 minutes per day, twice a week, in a home setting (intervention period).	Caregivers Caregivers are optionally enrolled to assist with technical arrangements and help manage study logistics. No interventions are administered to the caregiver group.
First Intervention (12 Weeks) Withdrawal by Subject	2	1	2

Baseline Characteristics

Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic

Baseline characteristics by cohort

Measure	Group A: Intervention, Then Non-intervention n=8 Participants Group A will self-administer Neuro-World cognitive training games for 30 minutes per day, twice a week, for 12 weeks in a home setting (intervention period). This will be followed by 12 weeks without any therapist-supervised cognitive therapies (non-intervention period).	Group B: Non-intervention, Then Intervention n=7 Participants Group B will first complete a 12-week non-intervention period without therapist-supervised cognitive therapies. This will be followed by 12 weeks of self-administered Neuro-World cognitive training games for 30 minutes per day, twice a week, in a home setting (intervention period).	Caregivers n=4 Participants Caregivers are optionally enrolled to assist with technical arrangements and help manage study logistics. No interventions are administered to the caregiver group.	Total n=19 Participants Total of all reporting groups
Age, Continuous	63.3 Years STANDARD_DEVIATION 13.2 • n=5 Participants	57.8 Years STANDARD_DEVIATION 10.1 • n=7 Participants	48.0 Years STANDARD_DEVIATION 19.6 • n=5 Participants	62.4 Years STANDARD_DEVIATION 11.7 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Game Intervention n=12 Participants Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	No Intervention n=12 Participants Study participants do not engage in any cognitive training.
Change in Montreal Cognitive Assessment (MoCA)	-2.0 score on a scale Standard Deviation 3.24	2.8 score on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Game Intervention n=12 Participants Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	No Intervention n=12 Participants Study participants do not engage in any cognitive training.
Change in Mini-Mental State Examination (MMSE)	0.5 score on a scale Standard Deviation 2.14	0.5 score on a scale Standard Deviation 1.85

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Game Intervention n=12 Participants Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	No Intervention n=12 Participants Study participants do not engage in any cognitive training.
Change in Digit Forward Span (DFS)	-0.2 score on a scale Standard Deviation 1.74	0.8 score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Game Intervention n=12 Participants Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	No Intervention n=12 Participants Study participants do not engage in any cognitive training.
Change in Digit Backward Span (DBS)	-1.1 score on a scale Standard Deviation 1.55	1.4 score on a scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Game Intervention n=12 Participants Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	No Intervention n=12 Participants Study participants do not engage in any cognitive training.
Change in Geriatric Depression Scale (GDS)	-0.8 score on a scale Standard Deviation 1.77	0.2 score on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Measure	Game Intervention n=12 Participants Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	No Intervention n=12 Participants Study participants do not engage in any cognitive training.
Change in Short Form 36 (SF-36) Mental Component Summary Score	-0.3 score on a scale Standard Deviation 5.68	0.3 score on a scale Standard Deviation 9.18

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Game Intervention n=12 Participants Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	No Intervention n=12 Participants Study participants do not engage in any cognitive training.
Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)	-0.5 score on a scale Standard Deviation 1.66	-0.1 score on a scale Standard Deviation 1.04

Adverse Events

Game Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Juhyeon Lee

University of Massachusetts Amherst

Phone: 413-404-4732

Email: juhyeonlee@cs.umass.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place