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

NCT07101380 | Recruiting

• 2 other identifiers: AJOUIRB-DE-2025-36RS-2024-00337993
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Mild Cognitive Impairment (MCI)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 14-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog14)

  The ADAS-cog14 is a comprehensive cognitive assessment tool that includes memory, attention and concentration, planning and executive function, visuoconstruction, and orientation. Scores range from 0 to 90, with higher scores indicating worse cognitive function. The assessment will be conducted at baseline and at the end of the intervention (Week 12).

  Baseline (Week 0, pre-intervention) and Week 12 (end of intervention)

Secondary Outcomes (13)

• Korean Mini-Mental State Examination, 2nd Edition (K-MMSE-2)

  Screening (within 14 days prior to baseline) and Week 12 (end of intervention)

• Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)

  Screening (within 14 days prior to baseline) and Week 12 (end of intervention)

• Korean Instrumental Activities of Daily Living (K-IADL)

  Screening (within 14 days prior to baseline) and Week 12 (end of intervention)

• Timed Up and Go test

  Baseline (Week 0, pre-intervention) and Week 12 (end of intervention)

• 30-second Sit-to-Stand Test

  Baseline (Week 0, pre-intervention) and Week 12 (end of intervention)

Study Arms (3)

Tablet-based intervention group

EXPERIMENTAL

Device: Tablet-based Physical SuperBrain BOOM

Smartphone-based intervention group

EXPERIMENTAL

Device: Smartphone-based SuperBrain BOOM

Control group

NO INTERVENTION

Interventions

Tablet-based Physical SuperBrain BOOM DEVICE

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.

Tablet-based intervention group

Smartphone-based SuperBrain BOOM DEVICE

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.

Smartphone-based intervention group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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)
• 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.
• 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.

You may not qualify if:

• 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.
• 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.).
• The investigator's judgment that the participant is unlikely to cooperate fully with the study.
• The investigator's judgment that the participant has difficulty safely participating in an exercise-based intervention program.
• Participation in another interventional clinical trial.

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (4)

Bundang CHA General Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• So Young Moon

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyunghwa Sun

CONTACT

+821071132730; nabear1001@naver.com

Daae Kim

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 3, 2025
• Study Start: February 23, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)