Trontinemab for Alzheimer's Disease
(TRONTIER 2 Trial)
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.12345Why 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.12356
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous (IV) trontinemab or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trontinemab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead 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