Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorEwha Womans University Mokdong Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
[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).
Disqualifiers
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).
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
4,000 Participants
are grouped into 1 trial groupGroup A: Open Label Registry
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 10 years2
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.
Time frame
Up to 10 years3
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.
Time frame
Up to 10 years4
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.
Time frame
Up to 10 yearsSecondary outcomes
1
Brain Magnetic Resonance Imaging (MRI)
Data will be collected to diagnose cognitive impairment and to assess for emergence of amyloid related imaging abnormalities.
Time frame
Up to 10 years2
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.
Time frame
Up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ewha Womans University Mokdong Hospital
Lead sponsor
Korean Dementia Association
Collaborator
Inha University Hospital
Collaborator
Gachon University Gil Medical Center
Collaborator
Saint Vincent's Hospital, Korea
Collaborator
Gangnam Severance Hospital
Collaborator
Konkuk University Hospital
Collaborator
Kyunghee University Medical Center
Collaborator
Korea University Medicine
Collaborator
Busan University Medical Center
Collaborator
CHA University
Collaborator
Samsung Medical Center
Collaborator
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
Asan Medical Center
Collaborator
Soonchunhyang University Hospital
Collaborator
Ajou University Hospital, Suwon, South Korea
Collaborator
Yonsei University Yongin Severance Hospital
Collaborator
Wonkwang University Hospital
Collaborator
Ewha Womans University Seoul Hospital
Collaborator
InjeUniversityBusanPaikHospital
Collaborator
Chonnam National University Hospital
Collaborator
Jeju National University Hospital
Collaborator
Chungnam National University Hospital
Collaborator
Gyungbook national university hospital
Collaborator
Hanllym University Medical Center
Collaborator
Heavenly Clinical Research
Collaborator
KangWon National University Hospital
Collaborator
Seoul St. Mary's Hospital, The Catholic University
Collaborator
Source ClinicalTrials.gov