Gantenerumab for Alzheimer's Disease
(DIAN-TU Trial)
Trial Summary
What is the purpose of this trial?
The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on stable doses of any non-excluded medications for at least 30 days before the trial starts. Some medications, like immunosuppressive drugs, are not allowed within 90 days before the trial.
What evidence supports the effectiveness of the drug gantenerumab for Alzheimer's disease?
Gantenerumab is a drug that targets and removes amyloid plaques in the brain, which are associated with Alzheimer's disease. Research suggests it has the potential to modify the disease by slowing or stopping its progression, similar to other anti-amyloid drugs like aducanumab, which has been approved for Alzheimer's treatment.12345
Is gantenerumab safe for humans?
Gantenerumab has been tested in clinical trials for Alzheimer's disease, and studies have looked at its safety, including how it is tolerated when injected under the skin. While the research focuses on Alzheimer's, it provides some information on safety in humans, such as the pain and tolerability of injections.13456
Research Team
Eric M McDade, DO
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for adults over 18 with a genetic mutation linked to early onset Alzheimer's Disease (AD), or those with a 50% chance of having the mutation. Participants must be within certain years of expected symptom onset, have normal cognitive function, and agree to use contraception if applicable. Those already on stable medication can join, except for certain episodic treatments.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 Treatment
Blinded placebo-controlled period to test if the study drug can slow, prevent, or reverse progression of Aβ pathology
Stage 2 Treatment
Open-label period to assess the study drug's effect on non-amyloid biomarkers of AD
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Gantenerumab (Monoclonal Antibodies)
- Matching Placebo (Gantenerumab) (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
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
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
Alzheimer's Association
Collaborator
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
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
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD