Feasibility Study of 'SuperBrain BOOM' for Mild Cognitive Impairment Patients (NCT07101380) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Feasibility Study of 'SuperBrain BOOM' for Mild Cognitive Impairment Patients
South Korea45 participantsStarted 2026-02-23
Plain-language 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
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: Between 50 and 85 years old.
. Meets all of the core clinical criteria for suspected Mild Cognitive Impairment (MCI) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines as of the screening date:
. Has one or more of the following neuropsychological test results within one year of the screening date, with delayed recall scores in the memory domain below the mean -1.0 standard deviation according to age- and education-adjusted normative data:
. As of the screening date, has a Korea-Mini Mental State Examination (K-MMSE-2) score that corresponds to at least -1.5 standard deviations below the mean based on age- and education-adjusted normative data.
. As of the screening date, has a Global Clinical Dementia Rating (CDR) score of 0.5, with a memory score of either 0.5 or 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
14-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog14)
Timeframe: Baseline (Week 0, pre-intervention) and Week 12 (end of intervention)
. Capable of using a tablet or smartphone with training, or has a research partner who can assist with using a tablet or smartphone.
. Has a caregiver who regularly contacts the participant:
A caregiver who is able to support the participant (monitor compliance and report participant status) and spends at least 8 hours per week with the participant during the trial period.
Exclusion criteria
. Presence of psychiatric disorders, such as major depression.
. Dementia.
. Other neurodegenerative diseases, such as Parkinson's disease.
. Malignant tumors within the past 5 years that have not been declared cured.
. Vascular surgery or stent placement within the past year.
. Severe or unstable symptomatic cardiovascular disease.
. Evidence of severe or unstable physical conditions, such as acute or severe asthma, active peptic ulcers, severe liver disease, kidney disease requiring dialysis, or any other medical conditions that may interfere with completing the clinical trial.
. Severe vision impairment, severe hearing loss, or communication difficulties that would prevent the participant from undergoing the intervention or efficacy assessments.