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

Launched by AJOU UNIVERSITY SCHOOL OF MEDICINE · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new program called SuperBrain BOOM, which is a personalized physical activity plan delivered through a tablet or smartphone. It’s designed for older adults between 50 and 85 years old who have mild cognitive impairment (MCI), a condition where thinking and memory skills are slightly worse than usual but daily activities can still be done independently. The study aims to find out if this program is safe and helpful in improving memory, thinking skills, physical health, mood, and overall quality of life.

People who join the study will use SuperBrain BOOM for 12 weeks, following exercises tailored just for them. They will also have regular check-ins to assess their thinking abilities, physical fitness, mood, and nutrition. A caregiver who spends time with the participant will help support them throughout the study. Participants need to be able to use a tablet or smartphone (or have help to do so) and must meet certain memory and thinking test scores to be eligible. The study will compare those using the program to others receiving their usual care to see how well SuperBrain BOOM works and whether people stick with it safely.

Gender

ALL

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.