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Monoclonal Antibodies

Investigational Alzheimer's Drugs for Early Onset Alzheimer's Disease (DIAN-TU Trial)

Phase 2 & 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

Individuals who know they have an Alzheimer's disease-causing mutation

Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 24, 52, 76, 104, 128, 156, 180 and 208

Awards & highlights

DIAN-TU Trial Summary

This trial is testing if an investigational product can improve Alzheimer's disease-related biomarkers and slow the rate of progression of cognitive or clinical impairment.

Who is the study for?

This trial is for individuals aged 18-80 who have a genetic mutation causing early onset Alzheimer's, are within -10 to +10 years of their predicted age of symptom onset, and can perform required tests (MRI, LP, PET). They must be cognitively normal or mildly impaired and have a reliable study partner. Women must use contraception if applicable.Check my eligibility

What is being tested?

The trial is testing Lecanemab and E2814 against a placebo to see if they improve Alzheimer's biomarkers and slow cognitive decline. Participants will receive either the investigational drugs or placebo to assess safety, tolerability, and effectiveness.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, headache, fatigue, allergic responses or infusion-related reactions. Side effects vary by individual; some may experience none while others could have more severe reactions.

DIAN-TU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I know I carry a gene mutation linked to Alzheimer's disease.

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I can see and hear well enough to complete tests.

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I am between 18 and 80 years old.

DIAN-TU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 24, 52, 76, 104, 128, 156, 180 and 208

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 24, 52, 76, 104, 128, 156, 180 and 208

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 24, 52, 76, 104, 128, 156, 180 and 208 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 end point is the change from Week 24 to Week 104 and Week 208 in tau PET in the Symptomatic Population (Cohort 1).

Secondary outcome measures

Asymptomatic Population (Cohort 2): Change from Week 0 to Week 52 in CSF ptau217/total tau

Asymptomatic Population (Cohort 2): Change from Week 52 to Week 104 and Week 208 in CSF neurofilament light chain (NfL)

Asymptomatic Population (Cohort 2): Key Secondary: Change from Week 0 to Week 104 and Week 208 in CSF ptau217/total tau

+4 more

DIAN-TU Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: E2814 plus lecanemabExperimental Treatment2 Interventions

Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 will receive intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 will receive intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period.

Group II: Matching placebo (E2814) plus lecanemabPlacebo Group2 Interventions

Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lecanemab

Not yet FDA approved

E2814

2019

Completed Phase 1

~80

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,941 Previous Clinical Trials

2,303,269 Total Patients Enrolled

Alzheimer's AssociationOTHER

91 Previous Clinical Trials

40,670 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,682 Previous Clinical Trials

28,026,018 Total Patients Enrolled

Media Library

E2814 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05269394 — Phase 2 & 3

Alzheimer's Disease Research Study Groups: E2814 plus lecanemab, Matching placebo (E2814) plus lecanemab

Alzheimer's Disease Clinical Trial 2023: E2814 Highlights & Side Effects. Trial Name: NCT05269394 — Phase 2 & 3

E2814 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269394 — Phase 2 & 3

Frequently Asked Questions

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

Are there still spots available for patients in this clinical trial?

"That is correct, the online information indicates that the trial is currently ongoing and looking for more participants. The trial was first posted on December 22nd, 2021 and was edited on August 4th, 2022. The study is looking for 168 patients to be recruited from 5 different locations."

Answered by AI

Does this research project allow for octogenarians to enroll?

"This trial includes all patients that fall between the ages of 18 to 80 years old."

Answered by AI

Does this trial have a large geographic footprint?

"At the moment, there are 5 clinical trial sites operational. These are in Saint Louis, Birmingham and Providence, with 5 other sites also running the trial. To limit travel burdens, it is best to select the clinical trial site closest to you."

Answered by AI