Disease-Modifying Drugs for Alzheimer's Disease
(DIAN-TU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain anticoagulants (blood thinners) except low-dose aspirin. It's best to discuss your specific medications with the trial team.
What safety data exists for lecanemab in humans?
How do the drugs E2814, Gantenerumab, Lecanemab, and Solanezumab differ from other Alzheimer's treatments?
These drugs are unique because they target amyloid-beta, a protein associated with Alzheimer's, using monoclonal antibodies (lab-made proteins that can bind to specific substances in the body). Lecanemab, for example, has shown promise in early Alzheimer's by reducing brain amyloid levels and improving cognitive function, while Gantenerumab is being studied for its potential to prevent Alzheimer's in people with genetic risk factors.12467
Who Is on the Research Team?
Randall J Bateman, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals aged 18-80 with or at risk of early onset Alzheimer's due to a genetic mutation. They must be able to undergo brain scans and tests, have a reliable study partner, and use effective contraception if applicable. Exclusions include significant health issues like heart disease, metal implants incompatible with MRI, recent drug/alcohol dependence, certain cancer histories, and pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cognitive Run-in
Cognitive, clinical, and imaging data collection to enhance study enrollment and provide baseline data
Treatment
Participants receive study drugs (e.g., E2814, lecanemab) or placebo, with some arms involving open-label administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may receive active study drug in an open-label extension period after completing the main treatment phase
What Are the Treatments Tested in This Trial?
Interventions
- E2814
- Gantenerumab
- Lecanemab
- Solanezumab
E2814 is already approved in United States for the following indications:
- Early Onset Alzheimer's Disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Avid Radiopharmaceuticals
Industry Sponsor
Dr. Daniel M. Skovronsky
Avid Radiopharmaceuticals
Chief Executive Officer since 2004
MD and PhD in Neuroscience from the University of Pennsylvania
Dr. Adam S. Fleisher
Avid Radiopharmaceuticals
Chief Medical Officer since 2022
MD, MAS
Eisai Inc.
Industry Sponsor
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
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen, LP
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Alzheimer's Association
Collaborator
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Hoffmann-La Roche
Industry Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Accelerating Medicines Partnership (AMP)
Collaborator