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A Multicenter, Prospective, Randomized, Investigator- Initiated Exploratory Study to Evaluate the Efficacy on Cognitive Function and Safety of 'SUPERBRAIN BOOM' in Patients With Mild Cognitive Impairment
The goal of this clinical trial is to learn whether a mobile-based personalized physical activity program called SuperBrain BOOM is safe and works to improve cognitive function, physical performance, mood, and quality of life in older adults (ages 50-85) with mild cognitive impairment (MCI). The main questions it aims to answer are: Can SuperBrain BOOM be safely and effectively used by people with MCI? Does the program help improve cognitive and physical function? Do participants stay engaged and complete the program as expected? Researchers will compare: A mobile intervention group using SuperBrain BOOM (on tablet or smartphone) A control group receiving usual care Participants will: Use a tablet or smartphone to follow a personalized physical activity program for 12 weeks Complete clinical assessments on cognition, physical ability, mood, and nutrition Be monitored for safety and program adherence using automatically collected data
This study is designed to assess the feasibility, safety, and potential benefits of a multi-domain personalized physical activity intervention-SuperBrain BOOM-delivered via mobile devices (tablet or smartphone) for individuals with Mild Cognitive Impairment (MCI). Mild Cognitive Impairment is a condition in which individuals experience noticeable cognitive decline without significant impairment in daily functioning. It is considered a transitional stage between normal aging and dementia. Evidence suggests that regular physical activity and cognitive engagement can delay or reduce the risk of progression to dementia. SuperBrain BOOM provides personalized exercise programs tailored to each participant's cognitive status, physical capacity, and lifestyle, and is designed to improve cognitive function, physical performance, emotional well-being, and quality of life. This randomized controlled trial will allocate participants into three groups: a mobile intervention group (tablet or smartphone) and a control group receiving usual care. The primary outcomes include changes in cognitive function, physical performance, mood, nutritional status, and quality of life over 12 weeks. Safety and adherence will be monitored throughout the intervention using system-generated data and clinical assessments. Secondary analyses will explore subgroup differences based on APOE genotype and demographic variables to better understand who benefits most from the intervention.
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
No
Bundang CHA General Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Pusan National University Hospital
Busan, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Start Date
February 23, 2026
Primary Completion Date
June 30, 2026
Completion Date
July 31, 2026
Last Updated
February 24, 2026
45
ESTIMATED participants
Tablet-based Physical SuperBrain BOOM
DEVICE
Smartphone-based SuperBrain BOOM
DEVICE
Daae Kim
CONTACT
Lead Sponsor
Ajou University School of Medicine
NCT06780917
NCT07449117
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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