Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
SUPERBRAIN
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
1 other identifier
interventional
300
1 country
17
Brief 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 cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
September 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2023
CompletedDecember 4, 2024
December 1, 2024
1.5 years
August 20, 2021
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
Change from Baseline at 24 weeks
Secondary Outcomes (11)
Change of global cognition
Change from Baseline at 24 weeks
Change of function
Change from Baseline at 24 weeks
Change of subjective memory
Change from Baseline at 24 weeks
Change of depression
Change from Baseline at 24 weeks
Change of quality of life
Change from Baseline at 24 weeks
- +6 more secondary outcomes
Study Arms (2)
Multidomain intervention
EXPERIMENTALThe 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.
Control
NO 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Dong-A University Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Eulji University Hospital
Daejeon, South Korea
Myungji Hospital
Goyang-si, South Korea
Chonnam University Hospital
Gwangju, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Bobath Memorial Hospital
Seongnam, South Korea
CHA Bundang Medical Center
Seongnam, South Korea
Ewha Womans Seoul Hospital
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Konkuk University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Related Publications (3)
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.
PMID: 41388319DERIVEDMoon 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.
PMID: 39840755DERIVEDCho 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.
PMID: 38362052DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seong Hye Choi, MD, PhD
Inha University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 20, 2021
First Posted
August 26, 2021
Study Start
September 23, 2021
Primary Completion
March 22, 2023
Study Completion
March 22, 2023
Last Updated
December 4, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available for 2 years since March 2024.
- Access Criteria
- Reasonable request
The data that support the findings of this study will be available from the principal investigator upon reasonable request.