Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)

NCT06889818 | Recruiting

• 1 other identifier: JOY-ALZ
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 3

Brief 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 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

Mild Cognitive Impairment; Dementia; Subjective Cognitive Decline (SCD); Alzheimer Disease

Keywords

Real World Data; Lecanemab

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Up to 10 years

Secondary Outcomes (2)

• Brain Magnetic Resonance Imaging (MRI)

  Up to 10 years

• Alzheimer's disease (AD) biomarkers

  Up to 10 years

Study Arms (1)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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:
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• \[Alzheimer's Disease Dementia (ADD)\] - 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.
• \[Mild Cognitive Impairment (MCI)\]
• \- 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.
• \[Cognitively Unimpaired (CU)\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead
• 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

Study Sites (3)

Gachon University Gil medical Center

Incheon, 21565, South Korea

RECRUITING

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Only if agreed, 1.5 tablespoons (23 cc) of blood

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Geon-ha Kim

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

• Seong-hye Choi

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Kee-hyung Park

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geon-ha Kim

CONTACT

82-2-587-7462; geonha@ewha.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 21, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: March 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

KR (3)