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Monoclonal Antibodies

lecanemab for Dementia (DIAN-TU Trial)

Phase 3

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 52, week 104, week 156, week 208, week 260, week 312, week 364

Awards & highlights

DIAN-TU 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.Check my eligibility

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.See study design

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.

DIAN-TU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 52, week 104, week 156, week 208, week 260, week 312, week 364

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week 52, week 104, week 156, week 208, week 260, week 312, week 364

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 52, week 104, week 156, week 208, week 260, week 312, week 364 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB).

DIAN-TU 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,940 Previous Clinical Trials

2,303,330 Total Patients Enrolled

17 Trials studying Dementia

6,520 Patients Enrolled for Dementia

Alzheimer's AssociationOTHER

91 Previous Clinical Trials

40,773 Total Patients Enrolled

32 Trials studying Dementia

32,394 Patients Enrolled for Dementia

Eisai Inc.Industry Sponsor

516 Previous Clinical Trials

158,971 Total Patients Enrolled

15 Trials studying Dementia

3,241 Patients Enrolled for Dementia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites can this study be accessed?

"At present, patient enrollment is ongoing at 8 distinct sites. Notable cities include La Jolla, Indianapolis, and Saint Louis among others. Opting for a site in close proximity can reduce the need for extensive travel during your potential participation in this trial."

Answered by AI

What is the safety profile of lecanemab for individuals?

"Our assessment at Power assigns a safety rating of 3 to lecanemab due to the Phase 3 trial stage, indicating existing efficacy data and robust safety information."

Answered by AI

Are individuals still eligible to participate in this ongoing research?

"The data on clinicaltrials.gov indicates that this particular medical trial is not currently seeking participants. Despite being initially posted on June 1st, 2024 and last modified on April 22nd, 2024, there are still a substantial number of active trials - around 780 studies - actively recruiting subjects at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease

2024. "DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06384573.