Alzheimers DiseaseNCT07762092
A Post Authorization Registry Study of Participants Treated With LEQEMBI
An observational study of Alzheimers Disease, run by Eisai Limited at 17 sites in Canada.
Trial summary
To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimers Disease
- How many people
- 400 participants
- Where
- 17 sitesCanada
- Study dates
- 30 Jul 2026to 1 Apr 2036
- How long will I take part?
- 3 Years
- 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 Canada and are enrolled into the Patient Registry.
Who may be able to join
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
Who cannot join
- None
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Canada17 sites, 17 recruiting
- Not yet recruiting
University of Calgary - Hotchkiss Brain Institute
Calgary, Alberta
- Not yet recruiting
University of Alberta, Geriatric Division
Edmonton, Alberta
- Not yet recruiting
Clinique Neuro-Outaouais
Gatineau, Quebec
- Recruiting
MOCA
Greenfield Park, Quebec
- Not yet recruiting
Kingston HHC (Queen University)
Kingston, Ontario
- Not yet recruiting
Parkwood Hospital - London
London, Ontario
- Not yet recruiting
Trillium Hospital
Mississauga, Ontario
- Not yet recruiting
IUGM
Montreal, Quebec
- Not yet recruiting
McGill University, Douglas Mental Health
Montreal, Quebec
- Not yet recruiting
Bruyère Institute
Ottawa, Ontario
- Recruiting
Kawartha Center
Peterborough, Ontario
- Not yet recruiting
CHU de Québec-Université Laval Research Center
Québec, Quebec
- Not yet recruiting
Sunnybrook Hospital
Toronto, Ontario
- Recruiting
Toronto Memory Program
Toronto, Ontario
- Not yet recruiting
Toronto Western Hospital
Toronto, Ontario
- Not yet recruiting
University of British Columbia - CARD
Vancouver, British Columbia
- Not yet recruiting
UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
Victoria, British Columbia
About this study
Official title: Post Authorization Registry Study of Patients Treated With LEQEMBI
To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy [CAA]).
The secondary purpose of this study is,
Read more
To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.
To describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality).
To describe drug utilization of LEQEMBI and to assess the effectiveness of risk minimization measures in routine clinical practice.
Read the detailed description
This is a noninterventional, prospective, observational Patient Registry study that will be conducted in Canada, the main purpose of which is to describe the incidence and severity of known adverse events in participants treated with LEQEMBI during routine clinical practice.
- Conditions
- Alzheimers 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
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Participants Treated With LEQEMBI | Participants treated with LEQEMBI in Canada 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 AEs
Incidence and severity of known AEs will be reported. AEs will include ARIA-E and ARIA-H (including asymptomatic and symptomatic) and ICH >1 cm in diameter in participants treated with LEQEMBI.
Measured: Up to 3 years
Secondary outcomes (5)
Time to Progression to the Next Stage of Alzheimer's Disease
Measured: Up to 3 years
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, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment.
Measured: Up to 3 years
Drug Utilization of LEQEMBI
Drug utilization will be assessed by count (n) and proportion (%) of age group, ethnicity, sex, residential location, APOE4 genotype, AD diagnosis, baseline MRI findings, baseline antithrombotic use, participants prescribed LEQEMBI according to PM, and treatment discontinuation by reason.
Measured: Up to 3 years
Duration of Treatment
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
Measured: Up to 3 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 MRI monitoring (before the 3rd, 5th, 7th, and 14th infusions), with dose suspension or discontinuation of LEQEMBI for ARIA or ICH >1 cm, and reporting physician compliance with providing educational materials at treatment initiation and after safety updates (if applicable), including type of materials, distribution method, and quantity.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start30 Jul 2026
- Primary completion1 Apr 2036 (estimated)
- Study completion1 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimers 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
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762092
- Sponsor's protocol ID
- BAN2401-A001-506
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Registry Study of Patients Treated With LEQEMBI
- ClinicalTrials.gov ID
- NCT07762092
- Acronym / sponsor ID
- BAN2401-A001-506
- Conditions
- Alzheimers Disease
- Keywords
- Alzheimer's Disease, Early Alzheimer's Disease, LEQEMBI, ARIA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 1 Apr 2036 (estimated)
- Study completion
- 1 Apr 2036 (estimated)
- First posted
- 13 Aug 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.
To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy [CAA]).
The secondary purpose of this study is,
To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.
To describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality).
To describe drug utilization of LEQEMBI and to assess the effectiveness of risk minimization measures in routine clinical practice.
Detailed description
This is a noninterventional, prospective, observational Patient Registry study that will be conducted in Canada, the main purpose of which is to describe the incidence and severity of known adverse events in participants treated with LEQEMBI during routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Treated With LEQEMBI | – | Other: No InterventionParticipants treated with LEQEMBI in Canada |
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 Canada and are enrolled into the Patient Registry.
Key inclusion criteria (1 listed)
- Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.
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 InterventionNo intervention. | Other | Participants Treated With LEQEMBI |
Primary outcome
Incidence and Severity of Known AEs
Time frame: Up to 3 years
Incidence and severity of known AEs will be reported. AEs will include ARIA-E and ARIA-H (including asymptomatic and symptomatic) and ICH >1 cm in diameter in participants treated with LEQEMBI.
5 secondary outcomes
Time to Progression to the Next Stage of Alzheimer's Disease
Time frame: Up to 3 years
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Time frame: Up to 3 years
Drug Utilization of LEQEMBI
Time frame: Up to 3 years
Duration of Treatment
Time frame: Up to 3 years
Effectiveness of Risk Minimization Measures
Time frame: Up to 3 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 5 Nov 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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimers Disease, run by Eisai Limited at 17 sites in Canada.
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 1 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada. 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 AEs (time frame: Up to 3 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 5 Nov 2026.