Gantenerumab for Alzheimer's Disease
(DIAN-TU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new drug, Gantenerumab, to determine if it can help individuals with a specific genetic mutation linked to Alzheimer's disease. The researchers will assess whether the drug can slow or prevent the buildup of harmful brain proteins, believed to contribute to Alzheimer's. Participants will receive either the drug or a placebo to compare effects. Suitable candidates have a known family mutation linked to Alzheimer's but have not yet shown cognitive symptoms. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking Alzheimer's research.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that remternetug has been tested for safety in people with early-stage Alzheimer's disease. In these studies, participants generally tolerated remternetug well. Some experienced mild side effects, but these were manageable. Importantly, no serious side effects directly linked to the drug were reported. This suggests that remternetug may be safe for humans, based on the available data from these trials. However, as with any treatment, all potential risks should be considered and discussed with a doctor.12345
Why are researchers excited about this trial's treatments?
Gantenerumab is unique because it targets amyloid-beta plaques in the brain, which are believed to play a key role in the development of Alzheimer's disease. Unlike other treatments that primarily focus on managing symptoms, Gantenerumab aims to modify the disease process itself by reducing these plaques. Researchers are excited about this approach because, if successful, it could potentially slow or halt the progression of the disease rather than just alleviate symptoms. Additionally, the trial includes Remternetug, another promising treatment that is being tested in both blinded and open-label stages, offering further insights into its effectiveness and safety.
What evidence suggests that Gantenerumab might be an effective treatment for Alzheimer's?
Research has shown that remternetug, which participants in this trial may receive, may help reduce amyloid plaques—sticky clumps that build up in the brains of people with Alzheimer's. One study found that 75% of participants taking remternetug experienced significant plaque reduction within 169 days. This is important because amyloid plaques are thought to contribute to the symptoms and progression of Alzheimer's disease. However, gantenerumab, another treatment option in this trial, did not slow the disease's progression in previous studies involving more than 2,800 participants. Overall, while remternetug appears effective at clearing plaques, it remains uncertain if it can slow down Alzheimer's disease itself.13678
Who Is on the Research Team?
Eric M McDade, DO
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Gantenerumab
- Matching Placebo (Gantenerumab)
Gantenerumab is already approved in United States for the following indications:
- Early onset Alzheimer's disease caused by a genetic mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
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
National Institute on Aging (NIA)
Collaborator
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