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Monoclonal Antibodies

Lecanemab for Alzheimer's Disease (DIAN-TU Trial)

Phase 3

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of recurrent ARIA-E (2 or more episodes regardless of location)

Uncontrolled seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to treat individuals with a specific genetic mutation that causes Alzheimer's disease. They will be treated with a drug called lecanemab to see if removing amyloid plaques from the brain

Who is the study for?

This trial is for individuals with a genetic form of Alzheimer's disease (DIAD) who were previously part of the DIAN-TU-001 study. Participants must carry specific mutations linked to early-onset Alzheimer's and are willing to undergo treatment with lecanemab.

What is being tested?

The study tests if lecanemab can remove amyloid plaques in the brain, which are associated with Alzheimer's, and examines its impact on delaying symptoms onset and slowing down disease progression compared to those not receiving it.

What are the potential side effects?

Lecanemab may cause side effects such as infusion-related reactions, bleeding or bruising more easily than normal, headaches, falls, diarrhea, or cough.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had two or more episodes of brain swelling.

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I have seizures that are not controlled by medication.

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I do not have any other active cancers that could affect this study.

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I do not have any uncontrolled conditions that threaten my life or could confuse my Alzheimer's diagnosis.

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I am on a strong blood thinner or taking high doses of medication to prevent blood clots.

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I have had large bleeds bigger than 1 cm.

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I have an autoimmune condition, low platelets, or a major mental health issue.

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My blood pressure is not controlled and averages above 97 mm Hg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: lecanemabExperimental Treatment1 Intervention

Starting at Week 0, participants will receive open-label lecanemab administered intravenously approximately every 2 weeks for a minimum of 5 years utilizing a common close design.

0 / 8Eligibility criteria met