Not yet recruitingOBSERVATIONAL

A Postmarketing Study of LEQEMBI in United Kingdom (UK) Participants With Alzheimer's Disease (AD)

This study is gathering important information about a new drug for Alzheimer's disease called LEQEMBI, used in standard care within the UK. It's not a trial where you get a new treatment; instead, it observes people who have already been prescribed LEQEMBI. The main aim is to understand more about its safety, especially looking for known side effects like swelling or small bleeds in the brain. Researchers also want to see how well the drug works in different people and check if measures to reduce risks are effective. This helps doctors and patients understand the drug better once it's available for wider use.

At a glance

Status

Not yet recruiting

Sponsor

Eisai Limited

Enrolment target

400

Start

31 Aug 2026

Estimated completion

31 Dec 2031

Alzheimers Disease

What is this study about?

Imagine a new medicine has been approved for use, but doctors and scientists still want to learn more about how it works in everyday life, outside of strict research studies. That's exactly what this study for the Alzheimer's drug LEQEMBI is doing in the UK.

This isn't a typical clinical trial where some people get the drug and others don't. Instead, it's an 'observational study'. This means researchers are simply observing patients who have already been prescribed LEQEMBI by their doctor as part of their regular treatment. They will collect information about their experiences.

The main goal is to understand the safety of LEQEMBI in a wider group of people. Researchers are particularly interested in certain known side effects, such as swelling or small bleeds in the brain (sometimes called ARIA-E or ARIA-H). They also want to see if these side effects are more common in certain groups, like those with particular genetic markers or who are taking blood-thinning medicines. The study will also look at how LEQEMBI is being used and how well the safety advice given to patients and doctors is working in practice.

Key takeaways

This study observes people already taking LEQEMBI for Alzheimer's disease in the UK.
It aims to learn more about the drug's safety and common side effects, like brain swelling or bleeding.
Participation means your routine medical information will be used; no extra visits or tests are needed.
This is not a traditional drug trial; you must already be prescribed LEQEMBI to join.
The study helps doctors understand how LEQEMBI works in real-world settings.
You can withdraw your consent for your data to be used at any time.

Who may be eligible?

To be part of this study, you must first have been diagnosed with Alzheimer's disease and already be prescribed the medicine LEQEMBI by your doctor. You (or your legal representative) would need to agree in writing to share your health information for the study.

If you are currently taking part in another clinical trial for Alzheimer's or a similar memory problem, or if you have previously used a similar type of anti-amyloid drug, then unfortunately you wouldn't be able to join this particular study. This is because the study is designed to look at people receiving LEQEMBI as part of their standard care, not as part of another research project.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with Alzheimer's disease?
Has my doctor prescribed me LEQEMBI?
Am I willing to allow my health information to be used for research?
Am I currently taking part in another Alzheimer's or memory-related clinical trial?
Have I used similar anti-amyloid drugs (like lecanemab) in the past?

Answer every question to see your result.

What does participation involve?

If you are already taking LEQEMBI, taking part in this study would simply involve allowing researchers to collect information about your health and your experience with the medicine from your medical records. You wouldn't have any extra visits, tests, or medication specifically for the study. You would continue to see your own doctor and receive your treatment as usual. The study doesn't involve giving you any new medicines or changing your current treatment plan.

Potential risks and benefits

There are no direct medical benefits or risks associated with simply being observed in this study, as you would already be receiving LEQEMBI treatment from your doctor. The main benefit is helping doctors and patients better understand the safety and effectiveness of LEQEMBI in the wider population. All participants have the right to withdraw their consent for their data to be used at any time without affecting their medical care.

Locations (3)

Scottish Brain Sciences
Verified postcode
Edinburgh, United Kingdom
Recognition Health Limited
Verified postcode
London, United Kingdom
Neuroclnx
Verified postcode
Motherwell, United Kingdom

Common questions

What is LEQEMBI?

LEQEMBI is a new medicine used to treat Alzheimer's disease. This study is watching how people use it in their everyday lives.

Is this a clinical trial where I might get a placebo?

No, this is not a trial where you might get a dummy drug (placebo). This study observes people who are already prescribed and taking LEQEMBI from their doctor.

Will I have to take any extra medicines?

No, you will not have to take any extra medicines for this study. You will continue with the LEQEMBI treatment your doctor has prescribed.

Will I need extra hospital visits?

No, there are no extra hospital visits required for this study. Your medical information will be collected from your existing healthcare records.

What kind of information will the study collect?

The study will collect information from your medical records about how you are doing on LEQEMBI, including any side effects you experience, to help understand the drug's safety better.

How to find out more

Eisai Medical Information

esi_medinfo@eisai.com +1-888-274-2378 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.