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Can Real-World data uncover hidden risks of the Alzheimer's drug LEQEMBI?

NCT ID NCT07762092

Knowledge-focused Sponsor: Eisai Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This registry study follows 400 Alzheimer's patients in Canada who are prescribed LEQEMBI, a medication for the disease. The goal is to track the frequency and severity of known side effects, such as brain swelling (ARIA-E), microbleeds (ARIA-H), and larger brain hemorrhages, during routine clinical care. It also looks for any new or unexpected long-term safety issues and how the drug is used in practice. By observing patients in real-world settings, the study aims to better understand the drug's safety profile beyond clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LEQEMBI (lecanemab), an Alzheimer's disease medication
What this could lead to
If successful, this study could provide a clearer picture of LEQEMBI's real-world safety, helping doctors manage risks like brain swelling or bleeding in Alzheimer's patients.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. It may also not capture all rare or long-term side effects due to its design and limited follow-up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada and are enrolled into the Patient Registry.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada. Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimers disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bruyère Institute

    Ottawa, Ontario, Canada

  • CHU de Québec-Université Laval Research Center

    Québec, Quebec, Canada

  • Kawartha Center

    Peterborough, Ontario, Canada

  • McGill University, Douglas Mental Health

    Montreal, Quebec, Canada

  • Parkwood Hospital - London

    London, Ontario, Canada

  • Sunnybrook Hospital

    Toronto, Ontario, Canada

  • Toronto Memory Program

    Toronto, Ontario, Canada

  • Toronto Western Hospital

    Toronto, Ontario, Canada

  • Trillium Hospital

    Mississauga, Ontario, Canada

  • UBC Victoria - Neil and Susan Manning Cognitive Health Initiative

    Victoria, British Columbia, Canada

  • University of British Columbia - CARD

    Vancouver, British Columbia, Canada

More trials for these conditions

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