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CompletedNo phase

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

Key facts

Who runs it
Ajou University School of Medicine
Where
South Korea4 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
45 people enrolled
Started
23 Feb 2026
Ended
9 Sept 2026
Type of study
Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Tablet-based Physical SuperBrain BOOM
  • Smartphone-based SuperBrain BOOM
Record updated
28 October 2026

Who can take part

Age
50 years to 85 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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
  • The participant provides written informed consent to participate in the study

Who cannot take part

  • Vascular surgery or stent placement within the past year
  • 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
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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).

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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

The 3 groups in the trial

  • Tablet-based intervention groupTreatment being tested

    Treatment: Tablet-based Physical SuperBrain BOOM

  • Smartphone-based intervention groupTreatment being tested

    Treatment: Smartphone-based SuperBrain BOOM

  • Control groupNo study treatment, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
28 October 2026