Trontinemab for Alzheimer's Disease

(TRONTIER 2 Trial)

Recruiting at 103 trial locations

Overseen By Reference Study ID Number: WN45443 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Disqualifiers: Cerebrovascular disease, CNS trauma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called trontinemab for individuals with early symptoms of Alzheimer's disease, such as mild memory problems or early dementia. The study aims to determine if trontinemab can slow or improve memory issues and assess its safety. Participants will receive either trontinemab or a placebo through an IV (intravenous, meaning directly into the vein). Those who have noticed a gradual memory decline over the past year and have been diagnosed with mild Alzheimer's or mild cognitive impairment due to Alzheimer's might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that trontinemab is still under testing, and complete safety information is not yet available. Earlier studies did not specify safety details solely for those taking the medication, as researchers examined all participants together. This makes it challenging to determine the exact safety of trontinemab. The company has not provided detailed information about possible side effects.

On a positive note, trontinemab demonstrated encouraging results in earlier studies, such as reducing amyloid plaques in the brain, which are linked to Alzheimer's disease. While this is promising, full safety details remain unavailable. Prospective trial participants should consult their healthcare provider and stay informed about any new findings. ^{1 2 3 4 5}

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

Unlike the standard treatments for Alzheimer's disease, which often focus on managing symptoms or slowing progression through medications like donepezil or memantine, Trontinemab offers a novel approach. This investigational drug works by targeting amyloid-beta plaques in the brain, a hallmark of Alzheimer's, potentially altering the disease's course rather than just addressing symptoms. Researchers are excited about Trontinemab because it is administered intravenously, which may ensure more consistent delivery and absorption compared to oral medications, potentially leading to more effective outcomes.

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

Research shows that trontinemab, which participants in this trial may receive, holds promise for treating early symptoms of Alzheimer's disease. Studies have found that trontinemab lowers amyloid levels—proteins linked to Alzheimer's—in 91% of participants. This reduction occurred in just 28 weeks. Trontinemab also cleared amyloid plaques in deep parts of the brain. These results suggest that trontinemab could effectively slow down or improve Alzheimer's symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people with early symptomatic Alzheimer's disease, including mild cognitive impairment or mild dementia. Participants must have certain scores on memory and cognitive tests, be able to undergo MRI and PET scans or spinal fluid tests, and have signs of Alzheimer's in these tests. They need good enough vision and hearing for testing (with aids if needed), a gradual memory decline over the past year, and a study partner.

Inclusion Criteria

I am willing and able to complete all study requirements, including MRI, genetic testing, and PET scans or CSF tests.

I can see and hear well enough to do tests, with glasses or hearing aids if I use them.

I have someone who can support me during the study.

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

24 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 trial is testing Trontinemab against a placebo to see if it's effective and safe for treating early-stage Alzheimer’s disease. Participants will either receive the actual drug or an inactive substance without knowing which one they are getting.

How Is the Trial Designed?

Group I: Trontinemab Experimental Treatment 1 Intervention

Participants will receive intravenous (IV) trontinemab.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive IV placebo.

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

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

Citations

1.

roche.com

roche.com/media/releases/med-cor-2025-07-28

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

In the 3.6 mg/kg cohort, trontinemab reduced amyloid levels below the 24 centiloid positivity threshold in 91% of participants (n=49/54) after ...

2.

globalalzplatform.org

globalalzplatform.org/2025/08/22/alz-forum-roche-spells-out-phase-three-plans-for-trontinemab/

Roche Spells Out Phase Three Plans for Trontinemab

At 3.6 mg/kg, 91 percent of participants were amyloid-negative after six months. · Trontinemab cleared plaque even in deep brain regions that ...

3.

ukdri.ac.uk

ukdri.ac.uk/news-and-events/results-trontinemab-phase-ii-trial-presented-aaic-conference

Results from trontinemab Phase II trial presented at AAIC

The trial, known as Brainshuttle™ AD, found nine in 10 people prescribed trontinemab experienced amyloid clearance within 28 weeks, meaning ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07169578

NCT07169578 | A Study of Trontinemab in Participants ...

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) ( ...

5.

psychiatrictimes.com

psychiatrictimes.com/view/positive-interim-results-on-trontinemab-validate-brainshuttle-technology-for-alzheimer-disease-treatment

Positive Interim Results on Trontinemab Validate ...

Results from the phase 1B/2A Brainshuttle AD study showed that trontinemab achieved rapid and robust amyloid plaque reduction at low systemic doses.

6.

alzheimersresearchuk.org

alzheimersresearchuk.org/news/potential-alzheimers-treatment-trontinemab-hits-the-news-how-does-it-work-and-is-it-available/

Potential Alzheimer's treatment, trontinemab, hits the news

Is trontinemab safe? The drug company have not yet published the full, unblinded safety data. So, it's not yet clear how common side effects ...