Mild Cognitive Impairment (MCI)KoCoA cohortNCT07485387
Global Collaborative Research on Establishing a Korean Cognitive Aging Cohort
An observational study of Mild Cognitive Impairment (MCI) and Dementia Alzheimer Type, run by Korea University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia Alzheimer Type, Chronic Pain
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2025to 31 Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study targets community-dwelling older adults aged 60 and older in Seoul, Republic of Korea. Participants are recruited from the Seongbuk Senior Welfare Center and Gangbuk Municipal Senior Welfare Center. Seongbuk-gu and Gangbuk-gu are districts with higher proportions of older adults and elevated chronic disease rates compared to other areas in Seoul, making them regions of interest for aging research. The study population includes older adults living independently in the community who utilize local senior welfare center services. By recruiting from these districts, the study aims to generate evidence for developing effective dementia prevention strategies applicable to community-based settings in Korea. Participants must be Samsung Galaxy smartphone users with sufficient cognitive ability to engage with ecological momentary assessment (EMA) protocols. Exclusions: dementia diagnosis, severe sensory impairments, or health conditions preventing participation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University
Seoul, Select One..., 02841
Sunmi Song, 01087489593, sunmi.song0715@gmail.com
About this study
Official title: Global Collaborative Research on Establishing a Korean Cognitive Aging Cohort That is Associated With the Einstein Aging Study
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?
Read more
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.
Read the detailed description
- 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.
- Research Design and Overview
- Korean Cohort Design that is comparable with the Einstein Aging Study
- The study adopts the Burst Cohort Design utilized by the U.S. Einstein Aging Study (EAS) for longitudinal analysis. To explore causal relationships and the role of mediators, a minimum of three repeated measurements-baseline, six-month follow-up, and one-year follow-up-will be conducted.
- The Burst Cohort Design involves short-term (daily) and long-term (annual) assessments. Daily changes, such as emotional states and cognitive performance, will be captured via mobile app-based surveys and stress biomarker sampling over two weeks. Long-term changes will be assessed through annual follow-ups.
- Participant Recruitment and Incentives
- Following IRB approval, socially vulnerable older adults (recipients of social welfare support due to economic poverty and social isolation) will be recruited through the Seongbuk Senior Welfare Center in Seoul, Republic of Korea. Training sessions on smartphone EMA will be provided as part of smartphone classes. Participants will receive tokens of appreciation and dementia prevention seminar opportunities.
- Participant Selection Criteria
- Inclusion: Community-dwelling older adults aged 65 or above.
- Exclusion: Individuals diagnosed with dementia or those with sensory, cognitive, or physical impairments that hinder survey and EMA participation.
- Two-Week EMA Protocol
- During the two-week intensive survey period, baseline surveys will assess depression, mild cognitive impairment, and other participant characteristics. Daily changes in emotional state, cognitive function, and social interactions will be measured via smartphone-based EMA surveys conducted 1-6 times daily.
- EMA minimizes recall and response biases, enabling precise quantification of intra-individual changes. Custom apps incorporating voice-assisted surveys and integration with Galaxy watch for sleep quality, heart rate variability, and physical activity data will be used, alongside cognitive tasks from the EAS protocol.
- Pro-Inflammatory Cytokine Signaling Measurement
- In collaboration with Korea University Anam Hospital, clinical diagnosis and biomarker collection for cognitive impairment will be conducted. Serum samples will be centrifuged within one hour and stored at -80°C.
- The samples will be sent to Penn State for analysis using the EAS protocol, targeting CRP, IL-6, IL-10, and TNF-α markers via multiplex bioassays. Additional cortisol ELISA and ApoE genetic variation analyses will be performed.
- Expected Impact and Merit to the society
- Utilization Plans ① Policy and Program Development:
- Insights from the study's findings on the bio-psycho-social mechanisms of cognitive decline in aging can inform policies and interventions for dementia prevention and management in a rapidly aging society.
- Advancement of National Dementia Research:
- Through international collaboration, the study will enhance methodologies and content for national cognitive aging and dementia research, leveraging the extensive experience of the Einstein Aging Study. Also, the current study will provide evidence for optimizing dementia prevention-related health services for socially vulnerable older adults.
- Anticipated Merits
- Scientific and Technological Merits:
- The study will provide a foundation for innovative elderly care models, linking digital sensing technologies with cognitive health monitoring. It could support the development of remote dementia prevention and management services for community and residential care settings.
- Economic, Industrial, and Social Merits:
- By understanding multidimensional mechanisms accelerating cognitive aging, the study will contribute to the integration of family and community-based elderly care, improvement in dementia diagnosis and prevention programs, reduction in family caregiving burdens, and enhancement of societal quality of life.
- Conditions
- Mild Cognitive Impairment (MCI), Dementia Alzheimer Type, Chronic Pain, Depression - Major Depressive Disorder
- Keywords
- mild cognitive impairment, dementia, chronic pain, depression, cognitive aging, longitudinal cohort, digital biomarkers, dementia biomarkers, behavioral phenotyping
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Chronic Pain, Dementia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community-Dwelling Older Adults in Seoul | Community-dwelling older adults aged 60 and older recruited from the Seongbuk Senior Welfare Center in Seoul, Republic of Korea. Inclusion criteria: Adults aged 60 or older residing in Korea; Samsung Galaxy smartphone users; MMSE score of 21 or above; those not meeting cognitive criteria may participate with legal guardian consent. Exclusion criteria: Dementia diagnosis at baseline; severe visual or hearing impairments; illiteracy; less than 80% compliance with 2-day preliminary EMA protocol; alcohol or substance abuse; inability to ambulate or psychiatric conditions preventing participation; current cancer treatment or chemotherapy within past 6 months. This is a prospective observational cohort. Participants complete baseline assessments, then a two-week EMA period using a smartphone app for daily emotions, cognition, and social interactions. Galaxy Watch monitors sleep, heart rate, and activity. Blood samples collected for inflammatory biomarkers. Follow-ups at 6 and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident MCI and Dementia Diagnosis
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.
Measured: baseline, 6-month, 1-year, 5-year and 10-year follow-up
SNSB-2 Composite Score
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).
Measured: Baseline and 12 months
Wechsler Memory Scale Score
Memory function assessed using the Wechsler Memory Scale (Index score (points)).
Measured: Baseline, 6 months, and 12 months
Block Design Subtest Score
Visuospatial constructional ability assessed using the Block Design subtest from the Wechsler Adult Intelligence Scale (WAIS) in Scaled score (points).
Measured: Baseline, 6 months, and 12 months
EMA Daily Cognitive Task Performance
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.
Measured: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Plasma Phosphorylated Tau (p-tau) Level
Plasma concentration of phosphorylated tau, a biomarker of tau-related neurodegeneration in Alzheimer's disease.
Measured: Baseline, 6 months, and 12 months
Pro-Inflammatory Cytokine Composite Score
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.
Measured: Baseline, 6 months, and 12 months
Plasma Amyloid Beta (Aβ) Level
Plasma concentration of amyloid beta, a biomarker associated with Alzheimer's disease neuropathology (pg/mL).
Measured: Baseline, 6 months, and 12 months
ApoE Genotype
Apolipoprotein E (ApoE) genetic variation determined by DNA analysis. Participants will be classified as ApoE ε4 carriers or non-carriers.
Measured: Baseline
Secondary outcomes (8)
EMA Daily Negative Affect
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).
Measured: Daily during 2-week EMA period at baseline, 6 months, and 12 months
EMA Daily Positive Affect
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).
Measured: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Depressive Symptoms
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.
Measured: Baseline, 6 months, and 12 months
EMA Daily Social Interaction Frequency
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
Measured: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Daily Sleep Quality
Sleep quality continuously monitored using Galaxy Watch during the 2-week EMA period, including total sleep time and sleep efficiency.
Measured: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Daily Heart Rate Variability (HRV)
Heart rate variability continuously monitored using Galaxy Watch during the 2-week EMA period.
Measured: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Daily Physical Activity Level
Physical activity continuously monitored using Galaxy Watch accelerometer during the 2-week EMA period (steps per day).
Measured: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Serum C-Reactive Protein (CRP) Level
High-sensitivity C-reactive protein measured from serum samples as a marker of systemic inflammation (mg/L).
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital, Penn State University, Albert Einstein College of Medicine
- Responsible party
- Principal investigator, Sunmi Song, Korea University
- Investigators
- Sunmi Song, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485387
- Sponsor's protocol ID
- KUIRB-2025-0072-02
- Other IDs
- RS-2024-00348012
- Acronym
- KoCoA cohort
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. According to the informed consent approved by the Institutional Review Board (IRB), participants agreed that their data would only be used by the authorized research team. Sharing IPD with external researchers was not included in the consent process, and doing so would violate the terms of consent and participant privacy protections.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Collaborative Research on Establishing a Korean Cognitive Aging Cohort That is Associated With the Einstein Aging Study
- ClinicalTrials.gov ID
- NCT07485387
- Acronym / sponsor ID
- KoCoA cohort / KUIRB-2025-0072-02
- Conditions
- Mild Cognitive Impairment (MCI), Dementia Alzheimer Type, Chronic Pain, Depression - Major Depressive Disorder
- Keywords
- mild cognitive impairment, dementia, chronic pain, depression, cognitive aging, longitudinal cohort, digital biomarkers, dementia biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital, Penn State University, Albert Einstein College of Medicine
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- Research Design and Overview
- Korean Cohort Design that is comparable with the Einstein Aging Study
- The study adopts the Burst Cohort Design utilized by the U.S. Einstein Aging Study (EAS) for longitudinal analysis. To explore causal relationships and the role of mediators, a minimum of three repeated measurements-baseline, six-month follow-up, and one-year follow-up-will be conducted.
- The Burst Cohort Design involves short-term (daily) and long-term (annual) assessments. Daily changes, such as emotional states and cognitive performance, will be captured via mobile app-based surveys and stress biomarker sampling over two weeks. Long-term changes will be assessed through annual follow-ups.
- Participant Recruitment and Incentives
- Following IRB approval, socially vulnerable older adults (recipients of social welfare support due to economic poverty and social isolation) will be recruited through the Seongbuk Senior Welfare Center in Seoul, Republic of Korea. Training sessions on smartphone EMA will be provided as part of smartphone classes. Participants will receive tokens of appreciation and dementia prevention seminar opportunities.
- Participant Selection Criteria
- Inclusion: Community-dwelling older adults aged 65 or above.
- Exclusion: Individuals diagnosed with dementia or those with sensory, cognitive, or physical impairments that hinder survey and EMA participation.
- Two-Week EMA Protocol
- During the two-week intensive survey period, baseline surveys will assess depression, mild cognitive impairment, and other participant characteristics. Daily changes in emotional state, cognitive function, and social interactions will be measured via smartphone-based EMA surveys conducted 1-6 times daily.
- EMA minimizes recall and response biases, enabling precise quantification of intra-individual changes. Custom apps incorporating voice-assisted surveys and integration with Galaxy watch for sleep quality, heart rate variability, and physical activity data will be used, alongside cognitive tasks from the EAS protocol.
- Pro-Inflammatory Cytokine Signaling Measurement
- In collaboration with Korea University Anam Hospital, clinical diagnosis and biomarker collection for cognitive impairment will be conducted. Serum samples will be centrifuged within one hour and stored at -80°C.
- The samples will be sent to Penn State for analysis using the EAS protocol, targeting CRP, IL-6, IL-10, and TNF-α markers via multiplex bioassays. Additional cortisol ELISA and ApoE genetic variation analyses will be performed.
- Expected Impact and Merit to the society
- Utilization Plans ① Policy and Program Development:
- Insights from the study's findings on the bio-psycho-social mechanisms of cognitive decline in aging can inform policies and interventions for dementia prevention and management in a rapidly aging society.
- Advancement of National Dementia Research:
- Through international collaboration, the study will enhance methodologies and content for national cognitive aging and dementia research, leveraging the extensive experience of the Einstein Aging Study. Also, the current study will provide evidence for optimizing dementia prevention-related health services for socially vulnerable older adults.
- Anticipated Merits
- Scientific and Technological Merits:
- The study will provide a foundation for innovative elderly care models, linking digital sensing technologies with cognitive health monitoring. It could support the development of remote dementia prevention and management services for community and residential care settings.
- Economic, Industrial, and Social Merits:
- By understanding multidimensional mechanisms accelerating cognitive aging, the study will contribute to the integration of family and community-based elderly care, improvement in dementia diagnosis and prevention programs, reduction in family caregiving burdens, and enhancement of societal quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-Dwelling Older Adults in Seoul | – | –Community-dwelling older adults aged 60 and older recruited from the Seongbuk Senior Welfare Center in Seoul, Republic of Korea. Inclusion criteria: Adults aged 60 or older residing in Korea; Samsung Galaxy smartphone users; MMSE score of 21 or above; those not meeting cognitive criteria may participate with legal guardian consent. Exclusion criteria: Dementia diagnosis at baseline; severe visual or hearing impairments; illiteracy; less than 80% compliance with 2-day preliminary EMA protocol; alcohol or substance abuse; inability to ambulate or psychiatric conditions preventing participation; current cancer treatment or chemotherapy within past 6 months. This is a prospective observational cohort. Participants complete baseline assessments, then a two-week EMA period using a smartphone app for daily emotions, cognition, and social interactions. Galaxy Watch monitors sleep, heart rate, and activity. Blood samples collected for inflammatory biomarkers. Follow-ups at 6 and 12 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study targets community-dwelling older adults aged 60 and older in Seoul, Republic of Korea. Participants are recruited from the Seongbuk Senior Welfare Center and Gangbuk Municipal Senior Welfare Center. Seongbuk-gu and Gangbuk-gu are districts with higher proportions of older adults and elevated chronic disease rates compared to other areas in Seoul, making them regions of interest for aging research. The study population includes older adults living independently in the community who utilize local senior welfare center services. By recruiting from these districts, the study aims to generate evidence for developing effective dementia prevention strategies applicable to community-based settings in Korea. Participants must be Samsung Galaxy smartphone users with sufficient cognitive ability to engage with ecological momentary assessment (EMA) protocols. Exclusions: dementia diagnosis, severe sensory impairments, or health conditions preventing participation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident MCI and Dementia Diagnosis
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.
SNSB-2 Composite Score
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).
Wechsler Memory Scale Score
Time frame: Baseline, 6 months, and 12 months
Memory function assessed using the Wechsler Memory Scale (Index score (points)).
Block Design Subtest Score
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).
EMA Daily Cognitive Task Performance
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.
Plasma Phosphorylated Tau (p-tau) Level
Time frame: 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
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.
Plasma Amyloid Beta (Aβ) Level
Time frame: Baseline, 6 months, and 12 months
Plasma concentration of amyloid beta, a biomarker associated with Alzheimer's disease neuropathology (pg/mL).
ApoE Genotype
Time frame: Baseline
Apolipoprotein E (ApoE) genetic variation determined by DNA analysis. Participants will be classified as ApoE ε4 carriers or non-carriers.
8 secondary outcomes
EMA Daily Negative Affect
Time frame: Daily during 2-week EMA period at baseline, 6 months, and 12 months
EMA Daily Positive Affect
Time frame: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Depressive Symptoms
Time frame: Baseline, 6 months, and 12 months
EMA Daily Social Interaction Frequency
Time frame: Daily during 2-week EMA period at baseline, 6 months, and 12 months
Daily Sleep Quality
Time frame: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Daily Heart Rate Variability (HRV)
Time frame: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Daily Physical Activity Level
Time frame: Continuous during 2-week EMA period at baseline, 6 months, and 12 months
Serum C-Reactive Protein (CRP) Level
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. According to the informed consent approved by the Institutional Review Board (IRB), participants agreed that their data would only be used by the authorized research team. Sharing IPD with external researchers was not included in the consent process, and doing so would violate the terms of consent and participant privacy protections.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunmi Song principal investigator
Korea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI) and Dementia Alzheimer Type, run by Korea University at 1 site 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunmi Song, PhD (+82232904439, sunmi.song0715@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident MCI and Dementia Diagnosis (time frame: baseline, 6-month, 1-year, 5-year and 10-year follow-up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.