Alzheimer's DiseaseNCT06810960
A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Eisai Korea Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate safety of LEQEMBI in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with alzheimer's disease prescribed LEQEMBI based on the approved prescribing information in South Korea and clinical judgement.
Who may be able to join
- Enrolled in JOY-ALZ before the decision to treat with LEQEMBI
- The clinical decision to treat with LEQEMBI has already been made
- Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.
Who cannot join
- Currently participating in an interventional clinical study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eisai Trial Site #1
Nutley, New Jersey, 07110
About this study
Official title: A 6-Year Postmarketing Safety and Clinical Outcome Study of LEQEMBI® in the Treatment of Alzheimer's Disease Using Real-World Data From South Korean Patients Enrolled Into the South Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ) Registry
The primary purpose of this study is to evaluate safety of LEQEMBI in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in patients treated with LEQEMBI.
- Conditions
- Alzheimer's Disease
- Being tested
- No Intervention
- Keywords
- Alzheimer's Disease, LEQEMBI, ARIA
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| LEQEMBI | Patients with alzheimer's disease treated with LEQEMBI in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from the JOY-ALZ registry. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events of Special Interest (AESIs)
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Measured: Up to 6 years
Exposure-adjusted Incidence Rate of AESIs
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Measured: Up to 6 years
Secondary outcomes (8)
Incidence of Adverse Events (AEs), Adverse drug reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs)
Measured: Up to 6 years
Exposure-Adjusted Incidence Rate of AEs, ADRs, SAEs, SADRs
Measured: Up to 6 years
Incidence of AEs and ADRs That are not Reflected in the Approved Prescribing Information
Measured: Up to 6 years
Exposure-Adjusted Incidence Rate of AEs and ADRs That are not Reflected in the Approved Prescribing Information
Measured: Up to 6 years
Incidence of ARIA-Related Events by Baseline Characteristics
Baseline characteristics include APOE4 genotype status, baseline magnetic resonance imaging (MRI) findings, prior Alzheimer's disease treatments, and antithrombotic therapy.
Measured: Up to 6 years
Exposure-Adjusted Incidence Rate of ARIA-Related Events by Baseline Characteristics
Baseline characteristics include APOE4 genotype status, baseline MRI findings, prior Alzheimer's disease treatments, and antithrombotic therapy.
Measured: Up to 6 years
Incidence of AEs by Baseline Characteristics
Baseline characteristics will include age, medical history, comorbidities, and concomitant medications.
Measured: Up to 6 years
Exposure-Adjusted Incidence Rate of AEs by Baseline Characteristics
Baseline characteristics will include age, medical history, comorbidities, and concomitant medications.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start24 Feb 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810960
- Sponsor's protocol ID
- BAN2401-M082-503
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Year Postmarketing Safety and Clinical Outcome Study of LEQEMBI® in the Treatment of Alzheimer's Disease Using Real-World Data From South Korean Patients Enrolled Into the South Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ) Registry
- ClinicalTrials.gov ID
- NCT06810960
- Acronym / sponsor ID
- BAN2401-M082-503
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, LEQEMBI, ARIA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate safety of LEQEMBI in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in patients treated with LEQEMBI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEQEMBI | – | Other: No InterventionPatients with alzheimer's disease treated with LEQEMBI in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from the JOY-ALZ registry. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with alzheimer's disease prescribed LEQEMBI based on the approved prescribing information in South Korea and clinical judgement.
Key inclusion criteria (3 listed)
- Enrolled in JOY-ALZ before the decision to treat with LEQEMBI
- The clinical decision to treat with LEQEMBI has already been made
- Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.
Key exclusion criteria (1 listed)
- Currently participating in an interventional clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | LEQEMBI |
Primary outcome
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Up to 6 years
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Exposure-adjusted Incidence Rate of AESIs
Time frame: Up to 6 years
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
8 secondary outcomes
Incidence of Adverse Events (AEs), Adverse drug reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs)
Time frame: Up to 6 years
Exposure-Adjusted Incidence Rate of AEs, ADRs, SAEs, SADRs
Time frame: Up to 6 years
Incidence of AEs and ADRs That are not Reflected in the Approved Prescribing Information
Time frame: Up to 6 years
Exposure-Adjusted Incidence Rate of AEs and ADRs That are not Reflected in the Approved Prescribing Information
Time frame: Up to 6 years
Incidence of ARIA-Related Events by Baseline Characteristics
Time frame: Up to 6 years
Exposure-Adjusted Incidence Rate of ARIA-Related Events by Baseline Characteristics
Time frame: Up to 6 years
Incidence of AEs by Baseline Characteristics
Time frame: Up to 6 years
Exposure-Adjusted Incidence Rate of AEs by Baseline Characteristics
Time frame: Up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Eisai Korea Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eisai Korea Inc. Medical department Serena SoYoun Kwon (+82-2-3451-5533, s-kwon@eisaikorea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events of Special Interest (AESIs) (time frame: Up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.