SuperBrain BOOM mobile physical-activity program for people with mild cognitive impairment

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

This program will test whether the SuperBrain BOOM app on a tablet or smartphone helps people aged 50–85 with mild cognitive impairment improve thinking, physical ability, mood, and quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Ajou University School of Medicine (Academic / other)
• Locations: 4 sites (Seongnam-si, Gyeonggi-do and 3 other locations)
• Trial ID: NCT07101380 on ClinicalTrials.gov

What this trial studies

This randomized controlled feasibility trial will compare personalized 12-week SuperBrain BOOM programs delivered on a tablet or smartphone with usual care in adults aged 50–85 diagnosed with mild cognitive impairment. Participants will follow tailored physical activity plans matched to cognitive status and physical capacity and complete clinical assessments of cognition, physical performance, mood, nutrition, and quality of life at baseline and after the intervention. Safety, adherence, and engagement will be monitored automatically through the mobile platform and by clinical staff. Secondary analyses will examine subgroup effects by APOE genotype and demographic factors to identify who benefits most.

Who should consider this trial

Good fit: Ideal candidates are adults 50–85 years old who meet NIA‑AA criteria for mild cognitive impairment, retain independence in daily activities, and can use a smartphone or tablet.

Not a fit: People with dementia, major physical or medical limitations that prevent safe participation, inability to use mobile devices, or those outside the 50–85 age range are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could provide an accessible, personalized way to slow cognitive decline and improve physical function, mood, and daily quality of life for people with MCI.

How similar studies have performed: Previous multi-domain and exercise trials (for example the FINGER trial) have shown cognitive and functional benefits in at-risk older adults, while purely mobile-delivered personalized programs remain less well studied.

Eligibility criteria

Inclusion Criteria:

1. Age: Between 50 and 85 years old.
2. 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:

   * Concerns of the participant or caregiver regarding cognitive decline compared to prior functioning.
   * Impairment in at least one cognitive domain.
   * Preserved independence in overall daily living activities.
   * No dementia.
3. 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:

   * Seoul Neuropsychological Screening Battery 2nd Edition (SNSB-II)
   * Korean version of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-K)
   * Literacy Independent Cognitive Assessment (LICA)
4. 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.
5. 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.
6. Capable of using a tablet or smartphone with training, or has a research partner who can assist with using a tablet or smartphone.
7. 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.
8. The participant provides written informed consent to participate in the study.

Exclusion Criteria:

1. Presence of psychiatric disorders, such as major depression.
2. Dementia.
3. Other neurodegenerative diseases, such as Parkinson's disease.
4. Malignant tumors within the past 5 years that have not been declared cured.
5. Vascular surgery or stent placement within the past year.
6. Severe or unstable symptomatic cardiovascular disease.
7. 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.
8. Severe vision impairment, severe hearing loss, or communication difficulties that would prevent the participant from undergoing the intervention or efficacy assessments.
9. Abnormal findings in clinical pathology tests related to cognitive decline, as determined by the clinical investigator (e.g., significant thyroid dysfunction, vitamin B12 or folate deficiency, neurosyphilis, etc.).
10. The investigator's judgment that the participant is unlikely to cooperate fully with the study.
11. The investigator's judgment that the participant has difficulty safely participating in an exercise-based intervention program.
12. Participation in another interventional clinical trial.

Where this trial is running

Seongnam-si, Gyeonggi-do and 3 other locations

• Bundang CHA General Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
• Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (Recruiting)
• Pusan National University Hospital — Busan, South Korea (Recruiting)
• Chonnam National University Hospital — Gwangju, South Korea (Recruiting)

Study contacts

• Principal investigator: So Young Moon — Ajou University School of Medicine
• Study coordinator: Kyunghwa Sun

Conditions Mild Cognitive Impairment; MCI; Physical Activity; SuperBrain BOOM; Digital Health; Dementia Prevention