Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
NCT07101380

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

Led by Ajou University School of Medicine · Updated on 2026-04-13

45

Participants Needed

4

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 85 years old
  • Meets core clinical criteria for suspected Mild Cognitive Impairment (MCI) per NIA-AA guidelines
  • Concerns about cognitive decline from participant or caregiver
  • Impairment in at least one cognitive domain
  • Preserved independence in daily living activities
  • No dementia diagnosis
  • At least one qualifying neuropsychological test result within one year showing delayed recall below -1.0 SD
  • Korea-Mini Mental State Examination score at least -1.5 SD below mean
  • Global Clinical Dementia Rating score of 0.5 with memory score 0.5 or 1
  • Capable of using a tablet or smartphone, or has a research partner to assist
  • Has a caregiver who supports and monitors, spending at least 8 hours per week
  • Provides written informed consent to participate
Not Eligible

You will not qualify if you...

  • Presence of psychiatric disorders such as major depression
  • Dementia diagnosis
  • Other neurodegenerative diseases like Parkinson's disease
  • Malignant tumors in past 5 years not declared cured
  • Vascular surgery or stent placement within past year
  • Severe or unstable cardiovascular disease
  • Severe or unstable physical conditions interfering with trial completion
  • Severe vision or hearing impairment or communication difficulties
  • Abnormal clinical pathology related to cognitive decline (e.g., thyroid dysfunction, vitamin deficiencies, neurosyphilis)
  • Investigator judges participant unlikely to cooperate fully
  • Investigator judges participant unsafe for exercise-based program
  • Participation in another interventional clinical trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Bundang CHA General Hospital

Seongnam-si, Gyeonggi-do, South Korea

Actively Recruiting

2

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea, 16499

Actively Recruiting

3

Pusan National University Hospital

Busan, South Korea

Actively Recruiting

4

Chonnam National University Hospital

Gwangju, South Korea

Actively Recruiting

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Research Team

K

Kyunghwa Sun

CONTACT

D

Daae Kim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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