Investigational Alzheimer's Drugs for Early Onset Alzheimer's Disease

(DIAN-TU Trial)

Recruiting at39 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Washington University School of Medicine

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests two drugs, lecanemab and E2814, in people with a genetic mutation that causes Alzheimer's disease. Lecanemab helps remove harmful protein clumps from the brain, while E2814 prevents harmful protein tangles from forming. The goal is to see if these drugs can slow down or improve symptoms of Alzheimer's.

Research Team

Randall J Bateman, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

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

I can see and hear well enough to complete tests.

For women of childbearing potential, if partner is not sterilized, participant must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide)

Exclusion Criteria

I haven't had cancer in the last 5 years, except for certain skin or prostate cancers that haven't worsened.

At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months. Current stable mild depression or current use of antidepressant medications is not exclusionary

History or presence of brain MRI scans indicative of any other significant abnormality

Treatment Details

Interventions

• E2814 (Monoclonal Antibodies)
• Lecanemab (Monoclonal Antibodies)
• Matching Placebo (E2814) (Other)

Trial Overview 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.

Participant Groups

Group I: E2814 plus lecanemab Experimental Treatment 2 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 lecanemab Placebo Group 2 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

Dr. Joanne Pike

Alzheimer's Association

Chief Executive Officer since 2023

DrPH in Public Health Leadership from the University of North Carolina at Chapel Hill

Dr. Maria C. Carrillo

Alzheimer's Association

Chief Medical Officer

PhD in Neuroscience

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Accelerating Medicines Partnership (AMP)

Collaborator

Trials

3

Recruited

880+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University