Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)
NCT ID: NCT06889818
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2025-02-24
2034-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Patients who have undergone an amyloid PET scan to confirm Alzheimer's disease pathology, or cerebrospinal fluid testing for Aβ42 and ptau181.
4. Clinical diagnosis of Alzheimer's disease, defined as follows:
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1. \[Alzheimer's Disease Dementia (ADD)\] - 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).
* Must exhibit cognitive decline that impairs independent daily living.
2. \[Mild Cognitive Impairment (MCI)\]
\- 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.
3. \[Cognitively Unimpaired (CU)\]
\- 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.
Exclusion Criteria
2. History of substance abuse or alcohol dependence that required treatment within the past five years.
3. 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.
4. Evidence of severe or unstable physical conditions (e.g., dialysis, severe liver disease).
5. Visual or auditory impairments that prevent the satisfactory assessment of cognitive function.
6. Inability to perform MRI due to the presence of metallic substances in the body.
7. Currently participating in another drug clinical trial.
8. Currently pregnant or breastfeeding.
19 Years
ALL
Yes
Sponsors
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Korean Dementia Association
UNKNOWN
Inha University Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Saint Vincent's Hospital, Korea
OTHER
Gangnam Severance Hospital
OTHER
Konkuk University Hospital
OTHER
Kyunghee University Medical Center
OTHER
Korea University Medicine
UNKNOWN
Busan University Medical Center
UNKNOWN
CHA University
OTHER
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Asan Medical Center
OTHER
Soonchunhyang University Hospital
OTHER
Ajou University Hospital, Suwon, South Korea
UNKNOWN
Yonsei University Yongin Severance Hospital
UNKNOWN
Wonkwang University Hospital
OTHER
Ewha Womans University Seoul Hospital
OTHER
InjeUniversityBusanPaikHospital
UNKNOWN
Chonnam National University Hospital
OTHER
Jeju National University Hospital
OTHER
Chungnam National University Hospital
OTHER
Gyungbook national university hospital
UNKNOWN
Hanllym University Medical Center
UNKNOWN
Heavenly Clinical Research
OTHER
KangWon National University Hospital
OTHER
Seoul St. Mary's Hospital, The Catholic University
UNKNOWN
Ewha Womans University Mokdong Hospital
OTHER
Responsible Party
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Geon Ha Kim
Principal Investigator
Principal Investigators
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Geon-ha Kim
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University Mokdong Hospital
Seong-hye Choi
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Kee-hyung Park
Role: PRINCIPAL_INVESTIGATOR
Gachon University Gil Medical Center
Locations
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Gachon University Gil medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JOY-ALZ
Identifier Type: -
Identifier Source: org_study_id
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