NCT07101380

Feasibility Study of 'SuperBrain BOOM' for Mild Cognitive Impairment Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Mild Cognitive Impairment (MCI)

Interventions

Type	Name	Description
DEVICE	Tablet-based Physical SuperBrain BOOM	This intervention is a tablet-based physical activity program designed for patients with Mild Cognitive Impairment (MCI). Participants receive a personalized exercise plan through a tablet application, with real-time feedback to enhance cognitive function. Compared to the smartphone-based version, this program is designed to provide a larger interface and structured environment, allowing participants to engage in the program using a tablet at home or in a clinical setting. The app also helps track progress and encourage adherence to the exercise regimen.
DEVICE	Smartphone-based SuperBrain BOOM	This intervention is a smartphone-based physical activity program designed for MCI patients. Participants receive a personalized exercise plan through a smartphone app, with real-time feedback to enhance cognitive function. Unlike the tablet-based intervention, this program is designed to be more portable and flexible, enabling participants to engage in the program from anywhere using their smartphones. The app also helps track progress and encourage adherence to the exercise regimen.

Timeline

• Start date: 2026-02-23
• Primary completion: 2026-06-30
• Completion: 2026-07-31
• First posted: 2025-08-03
• Last updated: 2026-04-13

Locations

4 sites across 1 country: South Korea