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10-Year watch: how safe is lecanemab outside clinical trials?

NCT ID NCT07821658

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are following thousands of people with Alzheimer's disease who receive lecanemab-irmb in routine care to see how often serious brain side effects occur. The study uses a national registry to track brain swelling, small bleeds, seizures, allergic reactions, strokes, and death over 10 years. It also checks whether risks differ based on genes, brain scans, other medications, or prior treatments. The goal is to understand the drug's safety in everyday practice, not just in controlled trials.

What this could mean

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

Active substance
lecanemab-irmb, an anti-amyloid antibody given for Alzheimer's disease
What this could lead to
If the registry confirms lecanemab's safety profile in everyday practice, doctors could have clearer guidance on which patients face higher risks and how to monitor them.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Real-world data may be incomplete or inconsistent, and rare side effects could still be missed.

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 6,700 people

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

Started

May 2025

Expected to finish

Jan 2035

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

Participants prescribed lecanemab-irmb by a physician participating in the ALZ-NET 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: * Enrolled in ALZ-NET * Either currently receiving or previously received lecanemab-irmb. 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.

Alzheimer's disease

How to take part

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

  1. The places running it

    1 site. 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

  • Eisai Trial Site #1

    RECRUITING

    Nutley, New Jersey, 07110, United States

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