Mild Cognitive ImpairmentJOY-ALZNCT06889818
Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)
An observational study of Mild Cognitive Impairment and Dementia, run by Ewha Womans University Mokdong Hospital at 3 sites in South Korea.
Trial summary
The purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Subjective Cognitive Decline (SCD)
- How many people
- 4,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 24 Feb 2025to 31 Dec 2034
- How long will I take part?
- 10 Years
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 40 medical institutions nationwide are expected to participate in the study over a period of 10 years, with about 4,000 participants in total. Our institution anticipates the participation of approximately 100 subjects. Participants in this study are adults with Alzheimer's disease dementia, mild cognitive impairment, or normal cognitive function (including subjective cognitive decline) who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, have made the decision to initiate treatment with these medications, or have already begun treatment with these newly approved Alzheimer's disease medications.
Who may be able to join
- Participants must be 19 years of age or older at the time of informed consent.
- Patients who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, patients who have decided to initiate treatment with these medications in consultation with their physician after 2021, or patients who have already started treatment with newly approved Alzheimer's disease medications after 2021.
- Patients who have undergone an amyloid PET scan to confirm Alzheimer's disease pathology, or cerebrospinal fluid testing for Aβ42 and ptau181.
- Clinical diagnosis of Alzheimer's disease, defined as follows:
- <!-- -->
- [Alzheimer's Disease Dementia (ADD)] - Must meet the criteria for probable Alzheimer's dementia as defined by the National Institute on Aging and the Alzheimer's Association working groups (NIA-AA).
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- Must exhibit cognitive decline that impairs independent daily living.
- [Mild Cognitive Impairment (MCI)]
- Must meet NIA-AA diagnostic criteria for MCI.
- The subject or informant must report cognitive decline.
- Performance on delayed recall of verbal memory must be more than -1.0 SD below the age- and education-adjusted normative mean, or scores on any one or more tests of executive function, language, visuospatial abilities, or attention must be more than -1.5 SD below the age- and education-adjusted normative mean.
- Clinical Dementia Rating scale (CDR) of 0.5.
- Maintenance of independent daily living ability.
- Not categorized as dementia.
- [Cognitively Unimpaired (CU)]
- Delayed recall of verbal memory must be at or above -1.0 SD versus the age- and education-adjusted normative mean, and all executive function, language, visuospatial abilities, and attention tests must be at or above -1.5 SD versus the age- and education-adjusted normative mean.
- Maintenance of independent daily living ability.
- If the subject reports cognitive decline, they will be classified as having Subjective Cognitive Decline (SCD).
- 5. Patients must be ambulatory (use of mobility aids is acceptable). 6. The subject must provide written informed consent to participate in the study. In the case of dementia patients, additional written consent from a guardian is required.
Who cannot join
- Presence of significant psychiatric disorders associated with intellectual disability, schizophrenia, major depression, bipolar disorder, delirium, etc.
- History of substance abuse or alcohol dependence that required treatment within the past five years.
- A current diagnosis of cancer that has not achieved remission within the past five years. However, localized prostate cancer, cervical carcinoma in situ, non-melanoma skin basal cell carcinoma, or squamous cell carcinoma are excluded.
- Evidence of severe or unstable physical conditions (e.g., dialysis, severe liver disease).
- Visual or auditory impairments that prevent the satisfactory assessment of cognitive function.
- Inability to perform MRI due to the presence of metallic substances in the body.
- Currently participating in another drug clinical trial.
- Currently pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Gachon University Gil medical Center
Incheon, 21565
Kee-hyung Park, 82-2-587-7462, khpark@gachon.ac.kr
Kee-hyung Park
- Recruiting
Inha University Hospital
Incheon, 22332
Seonghye Choi, 82-2-587-7462, seonghye@inha.ac.kr
Seong-hye Choi
- Not yet recruiting
Ewha Womans University Mokdong Hospital
Seoul, 07985
Geon-ha Kim, 82-2-587-7462, geonha@ewha.ac.kr
Geon-ha Kim
About this study
The purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's patients. The goal is to contribute to the precision of Alzheimer's treatment and to evaluate the impact of these new therapies and diagnostic techniques in clinical practice.
Read the detailed description
In 2024, it is estimated that there will be over 1 million individuals aged 65 and older with dementia in South Korea, with national dementia care costs exceeding approximately 17 trillion KRW (0.9% of GDP). South Korea is experiencing rapid population aging, leading to a projected significant increase in both the number of patients and the associated socio-economic costs. Alzheimer's disease (AD) is the most common cause of dementia and cognitive impairment in the elderly, characterized by the abnormal accumulation of amyloid beta (Aβ) and tau proteins in the brain. Research has shown that beta-amyloid protein begins to accumulate in the brain over 20 years before the onset of memory impairment symptoms. Consequently, Alzheimer's disease progresses through a prolonged asymptomatic stage of normal cognitive function (cognitively unimpaired, CU) to subjective cognitive decline, mild cognitive impairment, and dementia.
In May 2024, the Korean Ministry of Food and Drug Safety approved lecanemab for the treatment of Alzheimer's disease. Recent advancements have been made in the development of new treatments and diagnostic methods for Alzheimer's disease, with some already approved for use in South Korea or anticipated to receive approval soon. These developments are expected to significantly impact the management of dementia and cognitive impairment patients in the near future. Among the new treatments, monoclonal antibody injections targeting the core pathological mechanism of Alzheimer's disease, which is the removal of beta-amyloid protein (e.g., lecanemab, donanemab), currently lack long-term efficacy data, providing only 1-2 years of investigatory data in clinical trials. Such medications may have side effects, including amyloid-related imaging abnormalities (ARIA) such as brain edema or microbleeding and infusion-related adverse reactions. For the advancement of precise treatments for Alzheimer's disease, it is essential to monitor long-term effects and side effects of these drugs in clinical practice to collect and analyze more extensive clinical data to establish additional clinical evidence.
Moreover, the phase 3 clinical trial data for lecanemab suggests that the drug's effectiveness and side effects may vary by ethnicity. Recently, a diagnostic technique that measures Elecsys beta-amyloid 42 (Aβ42) and Elecsys Phospho-Tau181 (ptau181) in cerebrospinal fluid (CSF) has received approval from the Korean Ministry of Food and Drug Safety for the diagnosis of Alzheimer's disease. Additionally, there is a strong potential for new diagnostic methods that measure proteins such as ptau217, ptau181, and Aβ42 in blood to be commercialized in clinical practice. Future advancements through real-world data collection on these new diagnostic methods will be necessary.
The Alzheimer's Association (AA) and researchers in the United States have initiated a registry study named the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) to collect real-world data on new treatments and diagnostic methods for Alzheimer's disease. Longitudinal studies to investigate the long-term effectiveness and safety of new treatments and diagnostic methods in Alzheimer's patients are also being established in countries such as Japan, Australia, the Netherlands, and Europe. In response to these changes in Alzheimer's disease management, the researchers aim to contribute to the precision of Alzheimer's treatment and the enhancement of new diagnostic methods by collecting real-world data from Korean Alzheimer's patients regarding the long-term effectiveness and safety of new therapies.
- Conditions
- Mild Cognitive Impairment, Dementia, Subjective Cognitive Decline (SCD), Alzheimer Disease
- Keywords
- Real World Data, Lecanemab
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
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 |
|---|---|---|
| Open Label Registry | Collection of real-world data from enrolled patients being evaluated for or receiving novel Korea MFDS-approved Alzheimer's disease treatments and diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Korean Mini-Mental State Examination-2 (K-MMSE-2) total score
This test consists of orientation to time and place, three-word recall, subtracting 7 from 100 in succession, overlapping pentagon drawing, command execution, reading, writing, repeating, and naming. The score ranges from 0 to 30.
Measured: Up to 10 years
Change from baseline in the Korean version of Montreal Cognitive Assessment (K-MOCA) total score
This assessment evaluates memory, language, executive function, visuospatial construction, reasoning, and attention, with a scoring range of 0-30 points where higher scores indicate better cognitive function.
Measured: Up to 10 years
Change from baseline in the Clinical Dementia Rating scale (CDR) total score
Scores include a Global CDR (0-3 points) and a CDR-Sum of Boxes (SB) which sums the scores of the six domains (0-18 points). Higher scores indicate worse cognitive function.
Measured: Up to 10 years
Change from baseline in the Functional Assessment Questionnaire (FAQ) total score
The informant evaluates the subject, with a score range of 0-30, where higher scores indicate a decline in daily functioning. A score of 9 or more suggests significant deterioration in daily functioning.
Measured: Up to 10 years
Change from baseline in the Korean version of the Alzheimer disease 8 (K-AD8) total score
The score ranges from 0 to 8, where higher scores indicate more severe cognitive impairment.
Measured: Up to 10 years
Secondary outcomes (2)
Brain Magnetic Resonance Imaging (MRI)
Data will be collected to diagnose cognitive impairment and to assess for emergence of amyloid related imaging abnormalities.
Measured: Up to 10 years
Alzheimer's disease (AD) biomarkers
Data from past amyloid Positron Emission Tomography (PET) scans will be collected for the diagnosis of AD. Results for cerebrospinal fluid assays of Elecsys Aβ42, Elecsys ptau181, and ptau181/Aβ42 will also be collected. A ptau181/Aβ42 ratio greater than 0.023 indicates a suggestion of AD.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start24 Feb 2025
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Dementia Association, Inha University Hospital, Gachon University Gil Medical Center, Saint Vincent's Hospital, Korea, Gangnam Severance Hospital, Konkuk University Hospital, Kyunghee University Medical Center, Korea University Medicine, Busan University Medical Center, CHA University, Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital, Asan Medical Center, Soonchunhyang University Hospital, Ajou University School of Medicine, Yonsei University Yongin Severance Hospital, Wonkwang University Hospital, Ewha Womans University Seoul Hospital, InjeUniversityBusanPaikHospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University Hospital, Gyungbook national university hospital, Hallym University Medical Center, Heavenly Clinical Research, KangWon National University Hospital, Seoul St. Mary's Hospital
- Responsible party
- Principal investigator, Geon Ha Kim, Ewha Womans University Mokdong Hospital
- Investigators
- Geon-ha Kim, Principal investigator, Ewha Womans University Mokdong HospitalSeong-hye Choi, Principal investigator, Inha University HospitalKee-hyung Park, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889818
- Sponsor's protocol ID
- JOY-ALZ
- Acronym
- JOY-ALZ
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with Eisai and gAAIN.
Publications
Kim GH, Pyun JM, Kang D, Kang SH, Koh SH, Kim JS, Moon SY, Moon WJ, Park YH, Shim Y, Yang DW, Youn YC, Jung YH, Cho H, Choi H, Lim JS, Park KH, Choi SH. A Protocol of Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ). Dement Neurocogn Disord. 2026 Jan;25(1):25-41. doi: 10.12779/dnd.2026.25.1.25. Epub 2026 Jan 15.
PubMed 41657474
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)
- ClinicalTrials.gov ID
- NCT06889818
- Acronym / sponsor ID
- JOY-ALZ / JOY-ALZ
- Conditions
- Mild Cognitive Impairment, Dementia, Subjective Cognitive Decline (SCD), Alzheimer Disease
- Keywords
- Real World Data, Lecanemab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Collaborators
- Korean Dementia Association, Inha University Hospital, Gachon University Gil Medical Center, Saint Vincent's Hospital, Korea, Gangnam Severance Hospital, Konkuk University Hospital, Kyunghee University Medical Center, Korea University Medicine, Busan University Medical Center, CHA University, Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital, Asan Medical Center, Soonchunhyang University Hospital, Ajou University School of Medicine, Yonsei University Yongin Severance Hospital, Wonkwang University Hospital, Ewha Womans University Seoul Hospital, InjeUniversityBusanPaikHospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University Hospital, Gyungbook national university hospital, Hallym University Medical Center, Heavenly Clinical Research, KangWon National University Hospital, Seoul St. Mary's Hospital
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 21 Mar 2025 (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 purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's patients. The goal is to contribute to the precision of Alzheimer's treatment and to evaluate the impact of these new therapies and diagnostic techniques in clinical practice.
Detailed description
In 2024, it is estimated that there will be over 1 million individuals aged 65 and older with dementia in South Korea, with national dementia care costs exceeding approximately 17 trillion KRW (0.9% of GDP). South Korea is experiencing rapid population aging, leading to a projected significant increase in both the number of patients and the associated socio-economic costs. Alzheimer's disease (AD) is the most common cause of dementia and cognitive impairment in the elderly, characterized by the abnormal accumulation of amyloid beta (Aβ) and tau proteins in the brain. Research has shown that beta-amyloid protein begins to accumulate in the brain over 20 years before the onset of memory impairment symptoms. Consequently, Alzheimer's disease progresses through a prolonged asymptomatic stage of normal cognitive function (cognitively unimpaired, CU) to subjective cognitive decline, mild cognitive impairment, and dementia.
In May 2024, the Korean Ministry of Food and Drug Safety approved lecanemab for the treatment of Alzheimer's disease. Recent advancements have been made in the development of new treatments and diagnostic methods for Alzheimer's disease, with some already approved for use in South Korea or anticipated to receive approval soon. These developments are expected to significantly impact the management of dementia and cognitive impairment patients in the near future. Among the new treatments, monoclonal antibody injections targeting the core pathological mechanism of Alzheimer's disease, which is the removal of beta-amyloid protein (e.g., lecanemab, donanemab), currently lack long-term efficacy data, providing only 1-2 years of investigatory data in clinical trials. Such medications may have side effects, including amyloid-related imaging abnormalities (ARIA) such as brain edema or microbleeding and infusion-related adverse reactions. For the advancement of precise treatments for Alzheimer's disease, it is essential to monitor long-term effects and side effects of these drugs in clinical practice to collect and analyze more extensive clinical data to establish additional clinical evidence.
Moreover, the phase 3 clinical trial data for lecanemab suggests that the drug's effectiveness and side effects may vary by ethnicity. Recently, a diagnostic technique that measures Elecsys beta-amyloid 42 (Aβ42) and Elecsys Phospho-Tau181 (ptau181) in cerebrospinal fluid (CSF) has received approval from the Korean Ministry of Food and Drug Safety for the diagnosis of Alzheimer's disease. Additionally, there is a strong potential for new diagnostic methods that measure proteins such as ptau217, ptau181, and Aβ42 in blood to be commercialized in clinical practice. Future advancements through real-world data collection on these new diagnostic methods will be necessary.
The Alzheimer's Association (AA) and researchers in the United States have initiated a registry study named the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) to collect real-world data on new treatments and diagnostic methods for Alzheimer's disease. Longitudinal studies to investigate the long-term effectiveness and safety of new treatments and diagnostic methods in Alzheimer's patients are also being established in countries such as Japan, Australia, the Netherlands, and Europe. In response to these changes in Alzheimer's disease management, the researchers aim to contribute to the precision of Alzheimer's treatment and the enhancement of new diagnostic methods by collecting real-world data from Korean Alzheimer's patients regarding the long-term effectiveness and safety of new therapies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Registry | – | –Collection of real-world data from enrolled patients being evaluated for or receiving novel Korea MFDS-approved Alzheimer's disease treatments and diagnostics |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 40 medical institutions nationwide are expected to participate in the study over a period of 10 years, with about 4,000 participants in total. Our institution anticipates the participation of approximately 100 subjects. Participants in this study are adults with Alzheimer's disease dementia, mild cognitive impairment, or normal cognitive function (including subjective cognitive decline) who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, have made the decision to initiate treatment with these medications, or have already begun treatment with these newly approved Alzheimer's disease medications.
Key inclusion criteria (19 listed)
- Participants must be 19 years of age or older at the time of informed consent.
- Patients who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, patients who have decided to initiate treatment with these medications in consultation with their physician after 2021, or patients who have already started treatment with newly approved Alzheimer's disease medications after 2021.
- Patients who have undergone an amyloid PET scan to confirm Alzheimer's disease pathology, or cerebrospinal fluid testing for Aβ42 and ptau181.
- Clinical diagnosis of Alzheimer's disease, defined as follows:
- <!-- -->
Key exclusion criteria (8 listed)
- Presence of significant psychiatric disorders associated with intellectual disability, schizophrenia, major depression, bipolar disorder, delirium, etc.
- History of substance abuse or alcohol dependence that required treatment within the past five years.
- A current diagnosis of cancer that has not achieved remission within the past five years. However, localized prostate cancer, cervical carcinoma in situ, non-melanoma skin basal cell carcinoma, or squamous cell carcinoma are excluded.
- Evidence of severe or unstable physical conditions (e.g., dialysis, severe liver disease).
- Visual or auditory impairments that prevent the satisfactory assessment of cognitive function.
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
Change from baseline in the Korean Mini-Mental State Examination-2 (K-MMSE-2) total score
Time frame: Up to 10 years
This test consists of orientation to time and place, three-word recall, subtracting 7 from 100 in succession, overlapping pentagon drawing, command execution, reading, writing, repeating, and naming. The score ranges from 0 to 30.
Change from baseline in the Korean version of Montreal Cognitive Assessment (K-MOCA) total score
Time frame: Up to 10 years
This assessment evaluates memory, language, executive function, visuospatial construction, reasoning, and attention, with a scoring range of 0-30 points where higher scores indicate better cognitive function.
Change from baseline in the Clinical Dementia Rating scale (CDR) total score
Time frame: Up to 10 years
Scores include a Global CDR (0-3 points) and a CDR-Sum of Boxes (SB) which sums the scores of the six domains (0-18 points). Higher scores indicate worse cognitive function.
Change from baseline in the Functional Assessment Questionnaire (FAQ) total score
Time frame: Up to 10 years
The informant evaluates the subject, with a score range of 0-30, where higher scores indicate a decline in daily functioning. A score of 9 or more suggests significant deterioration in daily functioning.
Change from baseline in the Korean version of the Alzheimer disease 8 (K-AD8) total score
Time frame: Up to 10 years
The score ranges from 0 to 8, where higher scores indicate more severe cognitive impairment.
2 secondary outcomes
Brain Magnetic Resonance Imaging (MRI)
Time frame: Up to 10 years
Alzheimer's disease (AD) biomarkers
Time frame: Up to 10 years
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 21 Mar 2025.
- Derived from this study: PubMed 41657474Kim GH, Pyun JM, Kang D, Kang SH, Koh SH, Kim JS, Moon SY, Moon WJ, Park YH, Shim Y, Yang DW, Youn YC, Jung YH, Cho H, Choi H, Lim JS, Park KH, Choi SH. A Protocol of Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ). Dement Neurocogn Disord. 2026 Jan;25(1):25-41. doi: 10.12779/dnd.2026.25.1.25. Epub 2026 Jan 15.
- Individual participant dataSharing planned: Yes. Data will be shared with Eisai and gAAIN.
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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.
Geon-ha Kim principal investigator
Ewha Womans University Mokdong Hospital
Seong-hye Choi principal investigator
Inha University Hospital
Kee-hyung Park principal investigator
Gachon University Gil Medical Center
3 sites 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 and Dementia, run by Ewha Womans University Mokdong Hospital at 3 sites 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 19 inclusion and 8 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Geon-ha Kim (82-2-587-7462, geonha@ewha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Korean Mini-Mental State Examination-2 (K-MMSE-2) total score (time frame: Up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06889818, which also lists 1 linked publication.
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 21 Mar 2025.