Global Collaborative Research on Establishing a Korean Cognitive Aging Cohort That is Associated With the Einstein Aging Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incident MCI and Dementia Diagnosis
研究概览
简要总结
The goal of this observational study is to learn how daily emotional stress affects cognitive function and inflammation in community-dwelling older adults aged 60 and older in Seoul, Republic of Korea. The main questions it aims to answer are:
Does daily psychological stress measured in real-time affect short-term and long-term cognitive function in older adults? Do pro-inflammatory cytokines (such as CRP, IL-6, IL-10, and TNF-α) mediate the relationship between emotional stress and cognitive decline? How do social support and social isolation influence cognitive function and inflammatory biomarkers over time?
Participants will:
Complete baseline surveys assessing depression, cognitive function, and personal characteristics Use a smartphone app to answer brief surveys about their emotions, cognitive performance, and social interactions 1-6 times daily for two weeks Wear a Galaxy Watch to track sleep quality, heart rate, and physical activity Provide blood samples for inflammatory biomarker analysis Return for follow-up assessments at 6 months and 1 year
This study is part of an international collaboration to establish a Korean cohort comparable to the U.S. Einstein Aging Study, with the aim of developing culturally tailored dementia prevention strategies.
详细描述
A. Final Goal
• This study aims to identify the interactions between physiological, psychological, social, and cultural-environmental factors that influence the maintenance and decline of cognitive function in aging of socially vulnerable older adults. By doing so, it seeks to reduce the societal burden of cognitive decline in older adults and provide a foundation for effective interventions to manage dementia risk.
- The principal investigator's research team at Korea University's Department of Public Health Sciences and the team led by Professors Jennifer Graham-Engeland and Christopher Engeland from Penn State University (co-leaders of the Einstein Aging Study under NIH P01), aims to establish a protocol for the domestic cohort of the Einstein Study of Aging and conduct cross-national comparative research. The specific objectives are:
- Develop a Korean cohort protocol that is comparable to the Einstein Aging Study based on the principal investigator's existing community-based cohort studies with socially vulnerable older adults.
- Investigate the impact of real-time psychological stress (Ecological Momentary Assessment; EMA) on real-time and long-term cognitive function and examine the mediating effects of pro-inflammatory cytokine biomarkers through data collection in Korea.
- Compare Korean older adult data with the U.S. Einstein Study panel to study the influence of annual levels of social support and isolation on cognitive function and biomarkers, exploring the moderating effects of socio-environmental and cultural factors.
- Through this research, the principal investigator and international collaborators aim to utilize their expertise in real-time daily emotional and cognitive function measurements and inflammatory biomarker protocols. By integrating psychological research methodologies, the study seeks to elucidate the biological-neuropsychological mechanisms of how emotional stress impacts neuroinflammation and cognitive regulation in older adults. This will establish a foundation for developing dementia prevention and cognitive rehabilitation programs tailored to the Korean cultural context.
B. Research Design and Overview
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 60 or older residing in the Republic of Korea
- •Samsung Galaxy smartphone users capable of using smartphone applications
- •Sufficient cognitive ability to understand and follow research instructions (MMSE score of 21 or above)
- •For individuals who do not meet the cognitive criteria, those who understand the study procedures and provide informed consent along with their legal guardian
排除标准
- •Diagnosis of dementia at baseline
- •Severe visual or hearing impairments that prevent participation in psychological assessments
- •Illiteracy that prevents participation in cognitive testing
- •Less than 80% compliance with the 2-day preliminary EMA protocol (one additional attempt allowed after re-training)
- •Current alcohol or substance abuse
- •Inability to ambulate or psychiatric conditions that prevent survey participation
- •Currently undergoing cancer treatment or received chemotherapy within the past 6 months
结局指标
主要结局
Incident MCI and Dementia Diagnosis
时间窗: baseline, 6-month, 1-year, 5-year and 10-year follow-up
Incident mild cognitive impairment (MCI) and dementia diagnoses will be identified through clinical diagnosis during the study periods and linkage with the National Health Insurance Service (NHIS) database in Korea. This administrative data linkage enables long-term tracking of cognitive outcomes beyond the active study period.
SNSB-2 Composite Score
时间窗: Baseline and 12 months
Composite score from the Seoul Neuropsychological Screening Battery-2 (SNSB-2), a standardized neuropsychological assessment covering attention, language, visuospatial function, memory, and executive function domains (Standardized composite z-score).
Wechsler Memory Scale Score
时间窗: Baseline, 6 months, and 12 months
Memory function assessed using the Wechsler Memory Scale (Index score (points)).
Block Design Subtest Score
时间窗: Baseline, 6 months, and 12 months
Visuospatial constructional ability assessed using the Block Design subtest from the Wechsler Adult Intelligence Scale (WAIS) in Scaled score (points).
EMA Daily Cognitive Task Performance
时间窗: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Daily cognitive performance measured via smartphone-based ecological momentary assessment (EMA) using the Mobile Monitoring of Cognitive Change (M2C2) platform during the 2-week intensive period. Performance is assessed as accuracy (proportion correct) and reaction time on cognitive tasks.
Plasma Phosphorylated Tau (p-tau) Level
时间窗: Baseline, 6 months, and 12 months
Plasma concentration of phosphorylated tau, a biomarker of tau-related neurodegeneration in Alzheimer's disease.
Pro-Inflammatory Cytokine Composite Score
时间窗: Baseline, 6 months, and 12 months
Serum levels of pro-inflammatory cytokines including interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-α) will be measured using a multiplex ELISA. A cytokine composite score will be calculated using the factor analysis.
Plasma Amyloid Beta (Aβ) Level
时间窗: Baseline, 6 months, and 12 months
Plasma concentration of amyloid beta, a biomarker associated with Alzheimer's disease neuropathology (pg/mL).
ApoE Genotype
时间窗: Baseline
Apolipoprotein E (ApoE) genetic variation determined by DNA analysis. Participants will be classified as ApoE ε4 carriers or non-carriers.
次要结局
- EMA Daily Negative Affect(Daily during 2-week EMA period at baseline, 6 months, and 12 months)
- EMA Daily Positive Affect(Daily during 2-week EMA period at baseline, 6 months, and 12 months)
- Depressive Symptoms(Baseline, 6 months, and 12 months)
- EMA Daily Social Interaction Frequency(Daily during 2-week EMA period at baseline, 6 months, and 12 months)
- Daily Sleep Quality(Continuous during 2-week EMA period at baseline, 6 months, and 12 months)
- Daily Heart Rate Variability (HRV)(Continuous during 2-week EMA period at baseline, 6 months, and 12 months)
- Daily Physical Activity Level(Continuous during 2-week EMA period at baseline, 6 months, and 12 months)
- Serum C-Reactive Protein (CRP) Level(Baseline, 6 months, and 12 months)
研究者
Sunmi Song
Research Professor
Korea University