Alzheimer's DiseaseNCT07869264
An Observational Study of LEQEMBI in Routine Clinical Practice in Taiwan
An observational study of Alzheimer's Disease, run by Eisai Taiwan Inc. at 12 sites in Taiwan.
Trial summary
The primary purpose of this study is to describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema/effusion (ARIA-E), ARIA-microhemorrhage and haemosiderin deposit (ARIA-H), intracerebral hemorrhage greater than 1 cm, and anaphylaxis (stratified by… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 100 participants
- Where
- 12 sitesTaiwan
- Study dates
- 29 Oct 2026to 30 Sep 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan and are enrolled into the PASS Registry either prior to initiation or after beginning of therapy.
Who may be able to join
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan.
- Participants who have been prescribed LEQEMBI and who consent to enroll in the program.
Who cannot join
- None
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Taiwan12 sites
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Far Eastern Memorial Hospital
New Taipei City, 220
Cardinal Tien Hospital
New Taipei City, 231
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
New Taipei Municipal TuCheng Hospital
New Taipei City, 236
En Chu Kong Hospital
New Taipei City, 237
Chung Shan Medical University Hospital
Taichung, 402
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital-Taipei branch
Taipei, 104
Taipei Veterans General Hospital
Taipei, 112
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
About this study
Official title: An Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice in Taiwan
The primary purpose of this study is to describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema/effusion (ARIA-E), ARIA-microhemorrhage and haemosiderin deposit (ARIA-H), intracerebral hemorrhage greater than 1 cm, and anaphylaxis (stratified by apolipoprotein E4 variant [APOE4] genotype, concomitant antithrombotic therapy, and comorbid cerebral amyloid angiopathy [CAA]), in participants treated with LEQEMBI in routine clinical practice in Taiwan.
To describe previously unknown adverse events related to long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.
Read more
To describe progression to the next stage of Alzheimer's Disease (AD) in routine clinical practice.
To describe drug utilization of LEQEMBI and effectiveness of risk minimization measures in routine clinical practice.
- Conditions
- Alzheimer's Disease
- Being tested
- No Intervention
- Keywords
- Alzheimer's Disease, Early 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 |
|---|---|---|
| Participants Treated With LEQEMBI | Patients with Alzheimer's Disease treated with LEQEMBI in routine clinical practice. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Known Adverse Events (AEs)
Measured: Up to 2 years
Secondary outcomes (6)
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Incidence and severity of serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.
Measured: Up to 2 years
Time to Progression to the Next Stage of Alzheimer's Disease
The stages of disease are assessed by the clinician using tools that they use in routine clinical practice, and are mild cognitive impairment (MCI) due to AD, mild AD, moderate AD, or severe AD.
Measured: Up to 2 years
Drug Utilization of LEQEMBI
Drug utilization will be assessed by baseline demographics, apolipoprotein E4 variant (APOE4) genotype, AD diagnosis, and baseline magnetic resonance imaging (MRI) findings, baseline antithrombotic use.
Measured: Up to 2 years
Duration of Treatment
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
Measured: Up to 2 years
Incidence of Serious ARIA and ICH
Incidence of serious ARIA and ICH >1 cm in diameter will be assessed
Measured: Up to 2 years
Effectiveness of Risk Minimization Measures
Effectiveness of Risk Minimization Measures will be assessed by the proportion of participants using antithrombotic medications during treatment, demonstrating compliance with the MRI monitoring schedule and with dose suspension or discontinuation of LEQEMBI for ARIA-E, ARIA-H, or ICH >1 cm in diameter, and physician compliance with the package insert and providing educational materials to participants.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start29 Oct 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Taiwan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869264
- Sponsor's protocol ID
- BAN2401-T886-508
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice in Taiwan
- ClinicalTrials.gov ID
- NCT07869264
- Acronym / sponsor ID
- BAN2401-T886-508
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Early Alzheimer's Disease, LEQEMBI, ARIA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eisai Taiwan Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 9 Oct 2026 (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 describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema/effusion (ARIA-E), ARIA-microhemorrhage and haemosiderin deposit (ARIA-H), intracerebral hemorrhage greater than 1 cm, and anaphylaxis (stratified by apolipoprotein E4 variant [APOE4] genotype, concomitant antithrombotic therapy, and comorbid cerebral amyloid angiopathy [CAA]), in participants treated with LEQEMBI in routine clinical practice in Taiwan.
To describe previously unknown adverse events related to long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.
To describe progression to the next stage of Alzheimer's Disease (AD) in routine clinical practice.
To describe drug utilization of LEQEMBI and effectiveness of risk minimization measures in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Treated With LEQEMBI | – | Other: No InterventionPatients with Alzheimer's Disease treated with LEQEMBI in routine clinical practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan and are enrolled into the PASS Registry either prior to initiation or after beginning of therapy.
Key inclusion criteria (2 listed)
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Taiwan.
- Participants who have been prescribed LEQEMBI and who consent to enroll in the program.
Key exclusion criteria (1 listed)
- None
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 | Participants Treated With LEQEMBI |
Primary outcome
Incidence and Severity of Known Adverse Events (AEs)
Time frame: Up to 2 years
6 secondary outcomes
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Time frame: Up to 2 years
Time to Progression to the Next Stage of Alzheimer's Disease
Time frame: Up to 2 years
Drug Utilization of LEQEMBI
Time frame: Up to 2 years
Duration of Treatment
Time frame: Up to 2 years
Incidence of Serious ARIA and ICH
Time frame: Up to 2 years
Effectiveness of Risk Minimization Measures
Time frame: Up to 2 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 9 Oct 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.
12 sites 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 Taiwan Inc. at 12 sites in Taiwan.
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 2 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Taiwan. 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 Medical Information (+1-888-274-2378, esi_medinfo@eisai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Known Adverse Events (AEs) (time frame: Up to 2 years). 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 9 Oct 2026.