Korea University
Seoul, Select One..., 02841, South Korea
Location status: Recruiting
NCT Number: NCT07485387
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.
Interested in participating?
Request Info60 year and older
All sexes
Observational
Seoul, Select One..., 02841, South Korea
Location status: Recruiting
A. Final Goal
B. Research Design and Overview
C. Expected Impact and Merit to the society
① Policy and Program Development:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 6 months, and 12 months
Memory function assessed using the Wechsler Memory Scale (Index score (points)).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 6 months, and 12 months
Plasma concentration of phosphorylated tau, a biomarker of tau-related neurodegeneration in Alzheimer's disease.
Time frame: 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.
Time frame: Baseline, 6 months, and 12 months
Plasma concentration of amyloid beta, a biomarker associated with Alzheimer's disease neuropathology (pg/mL).
Time frame: Baseline
Apolipoprotein E (ApoE) genetic variation determined by DNA analysis. Participants will be classified as ApoE ε4 carriers or non-carriers.
Time frame: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Daily negative emotional states measured via smartphone-based EMA surveys administered 1-6 times per day during the 2-week intensive period (0-100 scale).
Time frame: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Daily positive emotional states measured via smartphone-based EMA surveys administered 1-6 times per day during the 2-week intensive period. The scores are assessed by a mean score (0-100 scale).
Time frame: Baseline, 6 months, and 12 months
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) at each follow-up visit. Yes/No coding will be used to assess reports of depressive symptoms.
Time frame: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Frequency of daily social interactions measured via smartphone-based EMA surveys during the 2-week intensive period. Unit of Measure: Number of interactions per day
Time frame: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Sleep quality continuously monitored using Galaxy Watch during the 2-week EMA period, including total sleep time and sleep efficiency.
Time frame: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Heart rate variability continuously monitored using Galaxy Watch during the 2-week EMA period.
Time frame: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Physical activity continuously monitored using Galaxy Watch accelerometer during the 2-week EMA period (steps per day).
Time frame: Baseline, 6 months, and 12 months
High-sensitivity C-reactive protein measured from serum samples as a marker of systemic inflammation (mg/L).
Time frame: Baseline and 12 months
Cortisol level measured from serum samples using enzyme-linked immunosorbent assay (ELISA) (nmol/L).
Contact information is provided by the study sponsor or research team.
Korea University
Other
Global Collaborative Research on Establishing a Korean Cognitive Aging Cohort That is Associated With the Einstein Aging Study
Acronym: KoCoA cohort
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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