Gantenerumab for Alzheimer's Disease (DIAN-TU Trial)
Recruiting in Palo Alto (17 mi)
+35 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Washington University School of Medicine
Prior Safety Data
Approved in 1 jurisdiction
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.
12345Is 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.
13456Eligibility 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.Participant Groups
The study tests Gantenerumab against a placebo in preventing or slowing amyloid beta accumulation in the brain, as seen by PET imaging. It also examines whether reducing amyloid plaques early affects AD progression by comparing biomarkers with an external control group.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Stage 1: RemternetugExperimental Treatment1 Intervention
Active Remternetug- blinded
Group II: Stage 2: Remternetug Open LabelActive Control1 Intervention
Open label will start after last dose of Stage 1
Group III: Stage 1: Matching Placebo (Remternetug)Placebo Group1 Intervention
Matching placebo
Gantenerumab is already approved in United States for the following indications:
🇺🇸 Approved in United States as Gantenerumab for:
- Early onset Alzheimer's disease caused by a genetic mutation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
USC Keck School of MedicineLos Angeles, CA
Washington University in St. LouisSaint Louis, MO
University of Alabama in BirminghamBirmingham, AL
University of California San Diego Medical CenterLa Jolla, CA
More Trial Locations
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
Eli Lilly and CompanyIndustry Sponsor
Hoffmann-La RocheIndustry Sponsor
Alzheimer's AssociationCollaborator
National Institute on Aging (NIA)Collaborator
Genentech, Inc.Industry Sponsor
References
Mechanism of amyloid removal in patients with Alzheimer disease treated with gantenerumab. [2019]Gantenerumab is a fully human anti-Aβ monoclonal antibody in clinical development for the treatment of Alzheimer disease (AD).
A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease. [2019]Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD).
Profile of gantenerumab and its potential in the treatment of Alzheimer's disease. [2021]Alzheimer's disease, which is characterized by gradual cognitive decline associated with deterioration of daily living activities and behavioral disturbances throughout the course of the disease, is estimated to affect 27 million people around the world. It is expected that the illness will affect about 63 million people by 2030, and 114 million by 2050, worldwide. Current Alzheimer's disease medications may ease symptoms for a time but are not capable of slowing down disease progression. Indeed, all currently available therapies, such as cholinesterase inhibitors (donepezil, galantamine, rivastigmine), are primarily considered symptomatic therapies, although recent data also suggest possible disease-modifying effects. Gantenerumab is an investigational fully human anti-amyloid beta monoclonal antibody with a high capacity to bind and remove beta-amyloid plaques in the brain. This compound, currently undergoing Phase II and III clinical trials represents a promising agent with a disease-modifying potential in Alzheimer's disease. Here, we present an overview of gantenerumab ranging from preclinical studies to human clinical trials.
Gantenerumab: an anti-amyloid monoclonal antibody with potential disease-modifying effects in early Alzheimer's disease. [2022]This review describes the research and development process of gantenerumab, a fully human anti-amyloid monoclonal antibody in development to treat early symptomatic and asymptomatic Alzheimer's disease (AD). Anti-amyloid monoclonal antibodies can substantially reverse amyloid plaque pathology and may modify the course of the disease by slowing or stopping its clinical progression. Several molecules targeting amyloid have failed in clinical development due to drug-related factors (e.g., treatment-limiting adverse events, low potency, poor brain penetration), study design/methodological issues (e.g., disease stage, lack of AD pathology confirmation), and other factors. The US Food and Drug Administration's approval of aducanumab, an anti-amyloid monoclonal antibody as the first potential disease-modifying therapy for AD, signaled the value of more than 20 years of drug development, adding to the available therapies the first nominal success since cholinesterase inhibitors and memantine were approved. BODY: Here, we review over 2 decades of gantenerumab development in the context of scientific discoveries in the broader AD field. Key learnings from the field were incorporated into the gantenerumab phase 3 program, including confirmed amyloid positivity as an entry criterion, an enriched clinical trial population to ensure measurable clinical decline, data-driven exposure-response models to inform a safe and efficacious dosing regimen, and the use of several blood-based biomarkers. Subcutaneous formulation for more pragmatic implementation was prioritized as a key feature from the beginning of the gantenerumab development program.
A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics After High-volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers. [2020]Gantenerumab, a fully human anti-amyloid-β IgG1 monoclonal antibody that binds to aggregated forms of amyloid-β, is being investigated as a potential disease-modifying treatment for early (prodromal to mild) Alzheimer disease (AD). Our study compared the pain associated with 5- and 15-s subcutaneous injections of gantenerumab and evaluated the tolerability and pharmacokinetic properties of subcutaneous gantenerumab.
Adverse drug reactions in patients with Alzheimer's disease and related dementia in France: a national multicentre cross-sectional study. [2013]To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France.