1600 Participants NeededMy employer runs this trial

Trontinemab for Alzheimer's Disease

(PrevenTRON Trial)

Recruiting at 71 trial locations
RS
Overseen ByReference Study ID Number: WN46072 https://forpatients.roche.com
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called trontinemab for individuals with early signs of Alzheimer's Disease (AD) who aren't yet experiencing memory or thinking problems. The goal is to determine if trontinemab can prevent or slow the progression to mild cognitive issues or dementia. Participants will receive either trontinemab or a placebo (a look-alike treatment with no active drug) to compare effects. Suitable candidates have evidence of Alzheimer's but haven't experienced memory or thinking problems and don't have other conditions affecting cognition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as anticoagulation medications and cholinesterase inhibitors. If you are on medications like opiates, opioids, benzodiazepines, barbiturates, hypnotics, antidepressants, or anxiety medications, you need to be on a stable dose for at least 8 weeks before starting the trial.

Is there any evidence suggesting that trontinemab is likely to be safe for humans?

Research has shown that trontinemab is generally safe and well-tolerated in people with Alzheimer's disease. In earlier studies, 91% of participants taking trontinemab experienced a significant drop in amyloid levels. Amyloid, a protein linked to Alzheimer's, decreases as a positive sign. Although specific side effects were not detailed, the studies suggest that most people tolerated trontinemab well. This is promising for those considering joining the clinical trial.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

Trontinemab is unique because it targets Alzheimer's disease differently than current treatments. While existing options like cholinesterase inhibitors and NMDA receptor antagonists primarily focus on managing symptoms, Trontinemab is an antibody designed to directly target and reduce the accumulation of amyloid plaques in the brain, which are believed to play a crucial role in the progression of Alzheimer's. Researchers are excited about Trontinemab because it offers a potential disease-modifying approach, aiming to address the root cause rather than just alleviating symptoms. This could represent a significant advancement in how Alzheimer's disease is treated.

What evidence suggests that trontinemab might be an effective treatment for Alzheimer's Disease?

Research has shown that trontinemab, which participants in this trial may receive, may help treat Alzheimer's Disease (AD). Studies have found that trontinemab effectively clears amyloid plaques from the brain. In one study, 92% of patients treated with trontinemab no longer had these plaques, which are linked to AD. Trontinemab enters the brain more easily than other treatments, allowing it to work well even at lower doses. Early results suggest it quickly and significantly reduces amyloid in most participants, making trontinemab a promising option for slowing or preventing Alzheimer's progression.26789

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people who show early biological signs of Alzheimer's disease but have no memory or thinking problems yet. Participants must be able to complete study tasks, have good vision and hearing (with aids if needed), weigh 150 kg or less, and have a study partner.

Inclusion Criteria

I have no problems with thinking or daily activities.
I can see and hear well enough to take part in mental tests, with glasses or hearing aids if needed.
My body weight is 150 kg or less.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) trontinemab or placebo

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Trontinemab

Trial Overview

The study tests whether trontinemab can help prevent or delay symptoms of Alzheimer's in at-risk individuals compared to a placebo. Participants are randomly assigned to receive either the drug or an inactive treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TrontinemabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

Alzheimer's Therapy Shows Promise with Roche's ...

Trontinemab is able to cross the blood brain barrier more easily than other amyloid beta targeting antibodies and so can be given at lower doses ...

Dementia research trials: What is trontinemab?

The trial called 'Brainshuttle AD', showed that amyloid was cleared in nine out of ten people within 28 weeks. This means that amyloid plaques, ...

Interim biomarker results for trontinemab, a novel Brainshuttle ...

Preliminary results from the ongoing Brainshuttle™ AD study suggest that rapid and deep amyloid reduction can be achieved in most participants at 1.8 and 3.6 mg ...

Clinical trial for Alzheimer's Disease (AD)-Genentech A M...

This study is testing a medicine called trontinemab. It is designed to remove amyloid plaques from the brain and is being developed to treat early symptoms of ...

Trontinemab

In March 2021, a Phase 1 trial called Brainshuttle AD began evaluating multiple doses in 120 people who have prodromal or mild to moderate ...

Roche presents new insights in Alzheimer's disease ...

trontinemab reduced amyloid levels below the 24 centiloid positivity threshold in 91% able safety and tolerability profile.

NCT07717411 | A Study of Trontinemab in Cognitively ...

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology

TRONTIER 1 and TRONTIER 2: Pivotal trials of trontinemab in ...

These studies will provide the opportunity to assess whether treatment with trontinemab slows disease progression in people living with early symptomatic AD.

A PHASE III, MULTICENTER, RANDOMIZED ...

Once in the brain, trontinemab works by removing amyloid-beta plaques, a protein associated with Alzheimer's disease. The study will last about 18 months. The ...