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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- 14-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog14)
研究概览
简要总结
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
详细描述
This study is designed to assess the feasibility, safety, and potential benefits of a multi-domain personalized physical activity intervention-SuperBrain BOOM-delivered via mobile devices (tablet or smartphone) for individuals with Mild Cognitive Impairment (MCI).
Mild Cognitive Impairment is a condition in which individuals experience noticeable cognitive decline without significant impairment in daily functioning. It is considered a transitional stage between normal aging and dementia. Evidence suggests that regular physical activity and cognitive engagement can delay or reduce the risk of progression to dementia.
SuperBrain BOOM provides personalized exercise programs tailored to each participant's cognitive status, physical capacity, and lifestyle, and is designed to improve cognitive function, physical performance, emotional well-being, and quality of life.
This randomized controlled trial will allocate participants into three groups: a mobile intervention group (tablet or smartphone) and a control group receiving usual care. The primary outcomes include changes in cognitive function, physical performance, mood, nutritional status, and quality of life over 12 weeks. Safety and adherence will be monitored throughout the intervention using system-generated data and clinical assessments.
Secondary analyses will explore subgroup differences based on APOE genotype and demographic variables to better understand who benefits most from the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •Presence of psychiatric disorders, such as major depression.
- •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.
研究组 & 干预措施
Control group
Tablet-based intervention group
干预措施: Tablet-based Physical SuperBrain BOOM (Device)
Smartphone-based intervention group
干预措施: Smartphone-based SuperBrain BOOM (Device)
结局指标
主要结局
14-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog14)
时间窗: Baseline (Week 0, pre-intervention) and Week 12 (end of intervention)
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).
次要结局
- 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))
- Assessment of Metabolic and Vascular Risk Factors(Screening (within 14 days prior to baseline) and Week 12 (end of intervention))
- 2-Minute Step Test(Baseline (Week 0, pre-intervention) and Week 12 (end of intervention))
- Quality of Life-Alzheimer's Disease (QOL-AD)(Screening (within 14 days prior to baseline) and Week 12 (end of intervention))
- Nutritional Quotient for Elderly (NQ-E)(Baseline (Week 0, pre-intervention) and Week 12 (end of intervention))
- Mini Nutritional Assessment (MNA)(Baseline (Week 0, pre-intervention) and Week 12 (end of intervention))
- Geriatric Depression Scale-15 items (GDS-15)(Screening (within 14 days prior to baseline) and Week 12 (end of intervention))
- Prospective and Retrospective Memory Questionnaire (PRMQ)(Screening (within 14 days prior to baseline) and Week 12 (end of intervention))
- Pittsburgh Sleep Quality Index (PSQI)(Screening (within 14 days prior to baseline) and Week 12 (end of intervention))
研究者
So Young Moon
Professor
Ajou University School of Medicine