Alzheimers DiseaseNCT07781345
A Postmarketing Study of LEQEMBI in United Kingdom (UK) Participants With Alzheimer's Disease (AD)
An observational study of Alzheimers Disease, run by Eisai Limited at 3 sites in United Kingdom.
Trial summary
The primary purpose of the study is to describe the incidence and severity of known adverse events (AEs), including Amyloid-Related Imaging Abnormalities Oedema/Effusion (ARIA-E), Amyloid-Related Imaging Abnormalities-Microhemorrhage and Haemosiderin Deposit (ARIA-H), intracerebral hemorrhage greater than (>) 1… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimers Disease
- How many people
- 400 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 31 Aug 2026to 31 Dec 2031
- 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: Participants with AD who are prescribed LEQEMBI by a physician in routine clinical practice in the UK.
Who may be able to join
- The participant (and/or legally authorised representative) has provided written informed consent to participate in the Post-Authorisation Safety Study (PASS) and for use of their protected health information (PHI).
- The participant is registered in the Controlled Access Programme (CAP) and has been prescribed LEQEMBI.
Who cannot join
- -Participation or planning to participate in randomised controlled trials (RCTs) for mild cognitive impairment (MCI) or AD, and patients who have had prior exposure to anti-amyloid monoclonal antibody (mAb) treatment including prior use of lecanemab.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites
Scottish Brain Sciences
Edinburgh, EH12 5PJ
Recognition Health Limited
London, W1G 8TA
Neuroclnx
Motherwell, ML1 4UF
About this study
Official title: A Prospective Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice
The primary purpose of the study is to describe the incidence and severity of known adverse events (AEs), including Amyloid-Related Imaging Abnormalities Oedema/Effusion (ARIA-E), Amyloid-Related Imaging Abnormalities-Microhemorrhage and Haemosiderin Deposit (ARIA-H), intracerebral hemorrhage greater than (>) 1 centimeter (cm) in diameter, and anaphylaxis (stratified by apolipoprotein E4 variant [APOE4] genotype, concomitant antithrombotic therapy, and comorbid Cerebral Amyloid Angiopathy [CAA]), of LEQEMBI in routine clinical practice.
Read the detailed description
This is a Post-Authorisation Safety Study registry designed to evaluate the safety, benefit-risk profile, drug utilisation, and effectiveness of risk minimisation measures of LEQEMBI in patients with AD in routine clinical practice
The secondary purposes of the study are:
- To describe the benefit-risk profile of LEQEMBI in routine clinical practice across patient subgroups as determined by progression to the next stage of AD (stratified by APOE4 genotype, concomitant antithrombotic therapy, and comorbid CAA).
- To describe previously unknown AEs 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 drug utilisation of LEQEMBI and effectiveness of risk minimisation measures in routine clinical practice.
- Conditions
- Alzheimers 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
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Participants Treated With LEQEMBI | Not described 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 ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis
Measured: Up to 3 years
Secondary outcomes (6)
Time to Progression to the Next Stage of Alzheimer's Disease (AD)
Measured: Up to 3 years
Incidence and Severity of Serious Suspected Adverse Reactions and Adverse Reactions Leading to Discontinuation of LEQEMBI Treatment
Measured: Up to 3 years
Drug Utilisation of LEQEMBI Based on Baseline Characteristics
Baseline demographics will include age/age group, sex, race, ethnicity, clinical disease stage, APOE4 genotypes, diagnosis of AD, baseline magnetic resonance imaging (MRI) findings consistent with a high risk of cerebral amyloid angiopathy (CAA), use of AD treatment, and use of concomitant antithrombotic medications at baseline.
Measured: Up to 3 years
Duration of Treatment
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
Measured: Up to 3 years
Incidence of Serious ARIA and ICH
Incidence of serious ARIA and ICH >1 cm in diameter will be assessed
Measured: Up to 3 years
Effectiveness of Risk Minimization Measures
Percentage of participants with use of antithrombotic medications, demonstrating compliance with magnetic resonance imaging (MRI) monitoring schedule, demonstrating compliance with dose suspension or discontinuation, and, physician compliance with the Summary of Product Characteristics (SmPC) and provision of participant with the Patient Alert Card (PAC) and Patient Information Leaflet (PIL).
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 posted24 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (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
- NCT07781345
- Sponsor's protocol ID
- BAN2401-E044-504
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT07781345
- Acronym / sponsor ID
- BAN2401-E044-504
- Conditions
- Alzheimers Disease
- Keywords
- Alzheimer's disease, LEQEMBI, ARIA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 24 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.
The primary purpose of the study is to describe the incidence and severity of known adverse events (AEs), including Amyloid-Related Imaging Abnormalities Oedema/Effusion (ARIA-E), Amyloid-Related Imaging Abnormalities-Microhemorrhage and Haemosiderin Deposit (ARIA-H), intracerebral hemorrhage greater than (>) 1 centimeter (cm) in diameter, and anaphylaxis (stratified by apolipoprotein E4 variant [APOE4] genotype, concomitant antithrombotic therapy, and comorbid Cerebral Amyloid Angiopathy [CAA]), of LEQEMBI in routine clinical practice.
Detailed description
This is a Post-Authorisation Safety Study registry designed to evaluate the safety, benefit-risk profile, drug utilisation, and effectiveness of risk minimisation measures of LEQEMBI in patients with AD in routine clinical practice
The secondary purposes of the study are:
- To describe the benefit-risk profile of LEQEMBI in routine clinical practice across patient subgroups as determined by progression to the next stage of AD (stratified by APOE4 genotype, concomitant antithrombotic therapy, and comorbid CAA).
- To describe previously unknown AEs 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 drug utilisation of LEQEMBI and effectiveness of risk minimisation measures in 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 Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with AD who are prescribed LEQEMBI by a physician in routine clinical practice in the UK.
Key inclusion criteria (2 listed)
- The participant (and/or legally authorised representative) has provided written informed consent to participate in the Post-Authorisation Safety Study (PASS) and for use of their protected health information (PHI).
- The participant is registered in the Controlled Access Programme (CAP) and has been prescribed LEQEMBI.
Key exclusion criteria (1 listed)
- -Participation or planning to participate in randomised controlled trials (RCTs) for mild cognitive impairment (MCI) or AD, and patients who have had prior exposure to anti-amyloid monoclonal antibody (mAb) treatment including prior use of lecanemab.
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 ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis
Time frame: Up to 3 years
6 secondary outcomes
Time to Progression to the Next Stage of Alzheimer's Disease (AD)
Time frame: Up to 3 years
Incidence and Severity of Serious Suspected Adverse Reactions and Adverse Reactions Leading to Discontinuation of LEQEMBI Treatment
Time frame: Up to 3 years
Drug Utilisation of LEQEMBI Based on Baseline Characteristics
Time frame: Up to 3 years
Duration of Treatment
Time frame: Up to 3 years
Incidence of Serious ARIA and ICH
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 24 Aug 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.
3 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 3 sites in United Kingdom.
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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis (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 24 Aug 2026.