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Mild Cognitive ImpairmentSUPERBRAINNCT05023057

Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

A study testing Multidomain intervention in people with Mild Cognitive Impairment, run by Inha University Hospital at 17 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild… Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Multidomain intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
17 sitesSouth Korea
Study dates
23 Sep 2021to 22 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 60 to 85 years of age
  • Having at least one modifiable dementia risk factor
  • Complaints of cognitive decline by a participant or informant
  • A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
  • MMSE Z score ≥ - 1.5
  • Independent activities of daily living
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  • Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
  • Having a reliable informant who could provide investigators with the requested information
  • Provide written informed consent

Who cannot join

  • Major psychiatric illness such as major depressive disorders
  • Dementia
  • Other neurodegenerative disease (e.g., Parkinson's disease)
  • Malignancy within 5 years
  • Cardiac stent or revascularization within 1 year
  • Serious or unstable symptomatic cardiovascular disease
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  • Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
  • Severe loss of vision, hearing, or communicative disability
  • Any conditions preventing cooperation as judged by the study physician
  • Significant laboratory abnormality that may result in cognitive impairment
  • Illiteracy
  • Unable to participate in exercise program safely
  • Coincident participation in any other intervention trial

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

South Korea17 sites

  • Dong-A University Hospital

    Busan

  • Pusan National University Hospital

    Busan

  • Eulji University Hospital

    Daejeon

  • Myungji Hospital

    Goyang-si

  • Chonnam University Hospital

    Gwangju

  • Inha University Hospital

    Incheon, 22332

  • Catholic Kwandong University International St. Mary's Hospital

    Incheon

  • Jeonbuk National University Hospital

    Jeonju

  • Bobath Memorial Hospital

    Seongnam

  • CHA Bundang Medical Center

    Seongnam

  • Ewha Womans Seoul Hospital

    Seoul

  • Ewha Womans University Mokdong Hospital

    Seoul

  • Hanyang University Hospital

    Seoul

  • Konkuk University Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Ajou University Hospital

    Suwon

  • Uijeongbu St. Mary's Hospital

    Uijeongbu-si

Other trials in South Korea

About this study

Official title: A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.

Read the detailed description

The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.

Being tested
Multidomain intervention
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidomain interventionBehavioural

    For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.

Study groups in NCT05023057
Study groupRoleWhat they receive
Multidomain interventionExperimentalThe participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.
Receives: Behavioral: Multidomain intervention
ControlNo interventionAt baseline, the participants in the control group will meet a study doctor, be prescribed medication when necessary, and receive educational booklets corresponding to their risk factors and a booklet on lifestyle guidelines to prevent dementia. They will receive usual care during the study period and be informed that they could participate in the multidomain intervention program after this study end.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of cognition

    Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.

    Measured: Change from Baseline at 24 weeks

Secondary outcomes (11)

  1. Change of global cognition

    Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.

    Measured: Change from Baseline at 24 weeks

  2. Change of function

    Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.

    Measured: Change from Baseline at 24 weeks

  3. Change of subjective memory

    Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.

    Measured: Change from Baseline at 24 weeks

  4. Change of depression

    Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.

    Measured: Change from Baseline at 24 weeks

  5. Change of quality of life

    Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.

    Measured: Change from Baseline at 24 weeks

  6. Change of activities of daily living

    Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.

    Measured: Change from Baseline at 24 weeks

  7. Change of nutritional behavior

    Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.

    Measured: Change from Baseline at 24 weeks

  8. Change of nutrition

    Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.

    Measured: Change from Baseline at 24 weeks

  9. Change of motor function

    Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.

    Measured: Change from Baseline at 24 weeks

  10. Change of sleep quality

    Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.

    Measured: Change from Baseline at 24 weeks

  11. Change of motivation

    Self Determination Index (SDI). Higher scores of SDI indicate better performance.

    Measured: Change from Baseline at 24 weeks. Higher scores indicate better performance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start23 Sep 2021
  3. Primary completion22 Mar 2023
  4. Study completion22 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
outcome assessor-blinded, randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05023057
Sponsor's protocol ID
2021-06-040
Acronym
SUPERBRAIN
Status last verified
Dec 2024
First submitted
20 Aug 2021
Last updated
4 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study will be available from the principal investigator upon reasonable request.

Publications

  • Kim DA, Lee SM, Sun K, Park JH, Park YK, Jeong JH, Hong CH, Jung J, Na HR, Cho SH, Kim HS, Song HS, Choi M, Ku BD, Moon Y, Han HJ, Hong YJ, Kim EJ, Kim GH, Kim KW, Jang H, Yoon SJ, Kim HJ, Choi SH, Moon SY. Multidomain Lifestyle Intervention in Mild Cognitive Impairment: Subgroup Analysis of the SUPERBRAIN-MEET Randomized Trial. Neurology. 2026 Aug 11;107(3):e218297. doi: 10.1212/WNL.0000000000218297. Epub 2026 Jul 20.

    PubMed 42475653

  • Hwang J, Moon SY, Lee H, Lee J, Park YK, Jeong JH, Hong CH, Jung J, Na HR, Cho SH, Sung J, Lee SJ, Choi SH. Polygenicity and APOE epsilon4 shape response to intervention in mild cognitive impairment. Alzheimers Res Ther. 2025 Dec 12;17(1):262. doi: 10.1186/s13195-025-01907-3.

    PubMed 41388319

  • Moon SY, Park YK, Jeong JH, Hong CH, Jung J, Na HR, Cho SH, Kim HS, Song HS, Choi M, Ku BD, Moon YS, Han HJ, Hong YJ, Kim EJ, Kim GH, Kim KW, Jang H, Yoon SJ, Kim HJ, Choi SH. South Korean study to prevent cognitive impairment and protect brain health through multidomain interventions via face-to-face and video communication platforms in mild cognitive impairment (SUPERBRAIN-MEET): A randomized controlled trial. Alzheimers Dement. 2025 Feb;21(2):e14517. doi: 10.1002/alz.14517. Epub 2025 Jan 22.

    PubMed 39840755

  • Cho SH, Kang HJ, Park YK, Moon SY, Hong CH, Na HR, Song HS, Choi M, Jeong S, Park KW, Kim HS, Chun BO, Jung J, Jeong JH, Choi SH. SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through Multidomain interventions via facE-to-facE and video communication plaTforms in mild cognitive impairment (SUPERBRAIN-MEET): Protocol for a Multicenter Randomized Controlled Trial. Dement Neurocogn Disord. 2024 Jan;23(1):30-43. doi: 10.12779/dnd.2024.23.1.30. Epub 2024 Jan 29.

    PubMed 38362052

Questions about this trial

What is this clinical trial studying?

A study testing Multidomain intervention in people with Mild Cognitive Impairment, run by Inha University Hospital at 17 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of cognition (time frame: Change from Baseline at 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05023057, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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