Actively Recruiting
Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)
Led by Ewha Womans University Mokdong Hospital · Updated on 2025-03-21
4000
Participants Needed
3
Research Sites
513 weeks
Total Duration
On this page
Sponsors
E
Ewha Womans University Mokdong Hospital
Lead Sponsor
K
Korean Dementia Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 19 years of age or older at the time of informed consent.
- Patients undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, or deciding to start or already started treatment after 2021.
- Patients who have had an amyloid PET scan or cerebrospinal fluid testing for Aβ42 and ptau181.
- Clinical diagnosis of Alzheimer's disease dementia meeting NIA-AA criteria with cognitive decline impairing daily living.
- Clinical diagnosis of mild cognitive impairment (MCI) meeting NIA-AA criteria with reported cognitive decline, specific memory or cognitive test scores, a Clinical Dementia Rating scale of 0.5, and maintained daily living ability without dementia.
- Cognitively unimpaired individuals with normal memory and cognitive test scores and maintained daily living ability; those reporting cognitive decline classified as subjective cognitive decline (SCD).
- Patients must be ambulatory (mobility aids allowed).
- Written informed consent from the participant; additional guardian consent required for dementia patients.
You will not qualify if you...
- Presence of significant psychiatric disorders such as intellectual disability, schizophrenia, major depression, bipolar disorder, or delirium.
- History of substance abuse or alcohol dependence requiring treatment in the past five years.
- Current cancer diagnosis without remission in the past five years, except localized prostate cancer, cervical carcinoma in situ, and certain skin cancers.
- Severe or unstable physical conditions like dialysis or severe liver disease.
- Visual or hearing impairments preventing cognitive assessments.
- Inability to undergo MRI due to metallic substances in the body.
- Participation in another drug clinical trial.
- Currently pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Gachon University Gil medical Center
Incheon, South Korea, 21565
Actively Recruiting
2
Inha University Hospital
Incheon, South Korea, 22332
Actively Recruiting
3
Ewha Womans University Mokdong Hospital
Seoul, South Korea, 07985
Not Yet Recruiting
Research Team
G
Geon-ha Kim
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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