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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• 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.

• \[Cognitively Unimpaired (CU)\]

• \- 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.

Locations
Other Locations
Republic of Korea
Gachon University Gil medical Center
RECRUITING
Incheon
Inha University Hospital
RECRUITING
Incheon
Ewha Womans University Mokdong Hospital
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
Geon-ha Kim
geonha@ewha.ac.kr
82-2-587-7462
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 4000
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Busan University Medical Center, Heavenly Clinical Research, Wonkwang University Hospital, Hanllym University Medical Center, KangWon National University Hospital, Gachon University Gil Medical Center, Inha University Hospital, Saint Vincent's Hospital, Korea, Seoul St. Mary's Hospital, The Catholic University, Soonchunhyang University Hospital, Korean Dementia Association, Seoul National University Bundang Hospital, Seoul National University Hospital, Asan Medical Center, Yonsei University Yongin Severance Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Ewha Womans University Seoul Hospital, Samsung Medical Center, Ajou University Hospital, Suwon, South Korea, Korea University Medicine, CHA University, Gyungbook national university hospital, InjeUniversityBusanPaikHospital, Konkuk University Hospital, Kyunghee University Medical Center, Jeju National University Hospital, Gangnam Severance Hospital
Leads: Ewha Womans University Mokdong Hospital

This content was sourced from clinicaltrials.gov