Trontinemab for Alzheimer's Disease

(TRONTIER 1 Trial)

Recruiting at 28 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, trontinemab, to evaluate its effectiveness and safety for individuals with early signs of Alzheimer's disease, such as mild memory issues or mild dementia. Participants will receive either trontinemab through an IV (intravenous) or a placebo, which resembles the treatment but contains no active medicine. The trial seeks individuals who have experienced a gradual decline in memory or thinking skills over the past year and have been informed they might have Alzheimer's disease. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity 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 trontinemab is likely to be safe for humans?

Research shows that trontinemab is under careful study for safety in people with Alzheimer's disease. In earlier studies, trontinemab appeared to help remove amyloid plaques in the brain, which are linked to Alzheimer's. However, the full safety details from these studies remain undisclosed, so the exact frequency of side effects is unknown.

The treatment has progressed to a Phase 3 trial, indicating that earlier phases did not reveal major safety issues. Phase 3 involves testing the treatment's safety in a larger group of people. While complete safety information is not yet available, the treatment has passed sufficient safety checks to reach this advanced stage of testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Trontinemab is unique because it targets Alzheimer's disease in a new way. Unlike most treatments that focus on managing symptoms, Trontinemab is designed to intervene at the disease's root by targeting specific proteins thought to contribute to its progression. Researchers are excited about Trontinemab's potential to slow or even halt the disease, offering hope for more effective long-term management compared to current options like cholinesterase inhibitors and NMDA receptor antagonists, which primarily address symptoms.

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 early Alzheimer's disease. In studies, 91% of participants experienced a significant drop in amyloid levels, proteins linked to Alzheimer's, after taking trontinemab. Most patients saw these harmful proteins clear from their brains within 28 weeks. This suggests that trontinemab could slow Alzheimer's by reducing amyloid levels. ^{1 2 3 4 5}

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 individuals with early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. Participants should meet specific criteria that will be detailed by the study organizers.

Inclusion Criteria

Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner

Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)

Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0

Exclusion Criteria

I have a condition that could affect my thinking or memory.

I have had significant stroke or brain blood vessel issues.

I have had a serious brain injury.

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, a new treatment for Alzheimer's. Participants will either receive trontinemab or a placebo (a substance with no active drug) to compare effects on symptoms and safety.

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. 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 ...

3. 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) ( ...

4. 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 ...

5. 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 Until these results released, we cannot say whether this drug could be effective in the treatment of Alzheimer's disease.