Korean Joint Registry for Alzheimer's Treatment and Diagnostics
Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)
This study is testing new Alzheimer's treatments, like lecanemab and donanemab, to see how well they work and are safe for people with Alzheimer's in South Korea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Ewha Womans University Mokdong Hospital Academic / other |
| Drugs / interventions | lecanemab, donanemab |
| Locations | 3 sites (Incheon and 2 other locations) |
| Trial ID | NCT06889818 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, while enhancing diagnostic methods for Alzheimer's disease. By collecting real-world data from Korean Alzheimer's patients, the study seeks to contribute to more precise treatment approaches and evaluate the impact of these therapies in clinical practice. The study is particularly relevant given the increasing prevalence of dementia in South Korea and the associated socio-economic costs.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 19 and older who are undergoing evaluation or treatment with newly approved Alzheimer's medications and have confirmed Alzheimer's disease pathology.
Not a fit: Patients who do not have a confirmed diagnosis of Alzheimer's disease or who are not undergoing treatment with the newly approved medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and diagnostic methods for Alzheimer's disease, benefiting patients with cognitive impairments.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating new Alzheimer's treatments, indicating a promising avenue for further research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Participants must be 19 years of age or older at the time of informed consent.
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:
1. Presence of significant psychiatric disorders associated with intellectual disability, schizophrenia, major depression, bipolar disorder, delirium, etc.
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.
Where this trial is running
Incheon and 2 other locations
- Gachon University Gil medical Center — Incheon, South Korea (Recruiting)
- Inha University Hospital — Incheon, South Korea (Recruiting)
- Ewha Womans University Mokdong Hospital — Seoul, South Korea (Not_yet_recruiting)
Study contacts
- Principal investigator: Geon-ha Kim — Ewha Womans University Mokdong Hospital
- Study coordinator: Geon-ha Kim
- Email: geonha@ewha.ac.kr
- Phone: 82-2-587-7462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.