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TRONTINEMAB

Clinical trials are studying TRONTINEMAB in people with Alzheimer’s disease, including prodromal, mild, and moderate stages. These studies are checking safety, tolerability, and whether TRONTINEMAB may slow disease progression or reduce brain amyloid, a protein linked to Alzheimer’s disease.

Table of Contents

Trial overview

TRONTINEMAB is being studied in interventional clinical trials, which means researchers assign study treatment and compare results across groups.[1][2][3] The listed trials focus on Alzheimer’s disease, including early and more advanced symptomatic stages.[1][2][3]

Three authorised studies are shown in the source data.[1][2][3] One is a Phase 1 study with 256 participants, and two are Phase 3 studies with 800 participants each.[1][2][3]

Who is being studied

The Phase 1 study includes participants with prodromal or mild to moderate Alzheimer’s disease.[1] Prodromal means an early stage where symptoms are starting, but are still relatively mild.

The two Phase 3 studies include participants with early symptomatic Alzheimer’s disease, described as mild cognitive impairment (MCI) to mild dementia due to AD.[2][3] MCI means thinking or memory problems that are worse than expected for age, but not yet as severe as dementia.

What the trials measure

The Phase 1 study mainly measures safety and tolerability, which means whether the treatment can be given without major problems and how well participants handle it.[1] It also measures pharmacodynamics, which in this trial means the effect of repeated doses on the body, and brain amyloid load by amyloid PET scan.[1]

The safety checks in the Phase 1 study include adverse events, laboratory tests, vital signs, physical and neurological exams, 12-lead ECG, and brain MRI findings, including vasogenic edema and hemorrhage.[1] These checks help researchers watch for changes in the body and brain during the study.

The Phase 3 studies focus on clinical progression over 72 weeks and compare TRONTINEMAB with placebo.[2][3] Their main outcome is change from baseline in the Clinical Dementia Rating, Sum of Boxes (CDR-SB), a scale used to track how dementia symptoms change over time.[2][3]

Trial phases and study design

The Phase 1 study is a multiple ascending dose trial, which means different dose levels are studied step by step to learn more about safety and early effects.[1] It also includes long-term administration in one part of the study.[1]

The Phase 3 studies are larger trials designed to test whether TRONTINEMAB changes disease course compared with placebo.[2][3] Both are authorised and use placebo comparison, which helps show whether any observed changes are likely due to the study treatment.[2][3]

Key trial details

Trial 2023-509678-52-00 is titled Brainshuttle AD and studies RO7126209, which the source data links with TRONTINEMAB, in participants with prodromal or mild to moderate Alzheimer’s disease.[1] The primary outcomes are safety events and change in brain amyloid load.[1]

Trial 2024-518006-40-00 studies TRONTINEMAB in early symptomatic Alzheimer’s disease and looks at change in CDR-SB at Week 72 versus placebo.[2] The study includes imaging tracers and placebo as part of the trial design, showing that researchers are comparing brain-related measures and clinical outcomes.[2]

Trial 2024-518008-33-00 is another Phase 3 study in the same early symptomatic population and uses the same main outcome, change in CDR-SB at Week 72.[3] Having two Phase 3 studies suggests a broader effort to confirm results in similar patient groups.[3]

What the endpoints mean

Primary outcome means the main result the researchers are trying to measure.[1][2][3] In the Phase 1 study, the main outcomes are safety-related and include brain MRI and amyloid PET results.[1]

In the Phase 3 studies, the main endpoint is the change in CDR-SB from baseline to Week 72.[2][3] Baseline means the starting point before treatment, and Week 72 means the planned follow-up timepoint after treatment has been given for a long period.

The source data also lists several imaging agents, including Amyvid, VIZAMYL, Neuraceq, and [18F]MK-6240, which are used in the study design for brain imaging measures.[2][3] These are part of how the trials assess brain changes, not separate treatment goals.

Trial ID Phase Condition studied Status Enrollment
2023-509678-52-00 Phase 1 Prodromal or mild to moderate Alzheimer’s disease Authorised 256
2024-518006-40-00 Phase 3 Early symptomatic Alzheimer’s disease (MCI to mild dementia due to AD) Authorised 800
2024-518008-33-00 Phase 3 Early symptomatic Alzheimer’s disease (MCI to mild dementia due to AD) Authorised 800

FAQ

  • What is being studied in TRONTINEMAB trials? The trials are studying TRONTINEMAB in Alzheimer’s disease. Researchers want to learn if it is safe, how well people tolerate it, and whether it may improve disease-related outcomes.
  • Who can take part in these studies? The studies include people with prodromal or mild to moderate Alzheimer’s disease, and people with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia due to AD.
  • What phases are the TRONTINEMAB trials in? One study is Phase 1 and two studies are Phase 3. Phase 1 focuses more on safety and early testing, while Phase 3 looks more closely at clinical benefit in larger groups.
  • What are the main outcomes being measured? The studies measure side effects and safety checks such as lab tests, vital signs, ECG, and brain MRI. They also measure brain amyloid load and clinical change over time using the CDR-SB scale.
  • Are placebo groups included? Yes. Some studies compare TRONTINEMAB with placebo TRONTINEMAB. This helps researchers see whether changes are due to the study treatment rather than chance.

Ongoing Clinical Trials on TRONTINEMAB

  • A study testing trontinemab compared to placebo in patients with early Alzheimer’s disease including mild cognitive impairment and mild dementia

    Recruiting

    3 1 1
    Investigated drugs:
    Denmark France Germany Italy Poland Spain

  • Study of Trontinemab Compared to Placebo for Patients with Early Symptomatic Alzheimer’s Disease

    Recruiting

    3 1 1
    Investigated drugs:
    Denmark France Germany Italy The Netherlands Poland +1

  • Study of RO7126209 safety and effects given by intravenous infusion in patients with early stage or mild to moderate Alzheimer’s disease

    Not recruiting

    1 1
    Investigated drugs:
    Poland Spain

Glossary

  • Alzheimer’s disease (AD): A brain disease that causes memory loss and problems with thinking and daily function. The trials study people at different stages of this condition.
  • Prodromal Alzheimer’s disease: An early stage of Alzheimer’s disease, when symptoms are starting but are still mild.
  • Mild cognitive impairment (MCI): A condition where thinking and memory are worse than expected for age, but daily life is not yet as affected as in dementia.
  • Mild dementia: An early stage of dementia where symptoms affect daily activities, but the person may still do many things independently.
  • Interventional study: A clinical trial where participants receive a study treatment or placebo so researchers can compare outcomes.
  • Phase 1: An early trial phase that mainly checks safety, tolerability, and how the body handles the treatment.
  • Phase 3: A later trial phase with more participants, used to study whether a treatment works and to gather more safety data.
  • Placebo: A study treatment that looks like the real treatment but has no active medicine. It is used for comparison.
  • Amyloid PET scan: A brain scan used to measure amyloid load, meaning how much amyloid is present in the brain.
  • Clinical Dementia Rating, Sum of Boxes (CDR-SB): A scale that measures how severe dementia symptoms are and how they change over time.
  • Electrocardiogram (ECG): A test that records the heart’s electrical activity.
  • Magnetic resonance imaging (MRI): A scan that gives detailed pictures of the brain. In these trials, it is used to check for changes such as edema or hemorrhage.

References

  1. https://clinicaltrials.gov/study/2023-509678-52-00
  2. https://clinicaltrials.gov/study/2024-518006-40-00
  3. https://clinicaltrials.gov/study/2024-518008-33-00