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RecruitingPHASE3INTERVENTIONAL

A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

This research study is investigating a new medication called Trontinemab for individuals in the early stages of Alzheimer's disease. This includes people experiencing mild memory and thinking problems that are due to Alzheimer's, or those with early Alzheimer's dementia. The main goal is to find out if Trontinemab is effective at improving or stabilising these symptoms, and importantly, if it is safe for patients. To do this, some participants will receive Trontinemab, while others will receive a placebo, which looks like the active drug but has no medicine in it. Researchers will carefully compare the results from both groups to understand the potential of this new treatment for Alzheimer's disease.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
800
Start
17 Sep 2025
Estimated completion
07 Jun 2028

What is this study about?

This study is focused on a new potential treatment for Alzheimer's disease called Trontinemab. Alzheimer's is a condition that affects memory, thinking, and daily activities. This particular study is for people who are in the early stages – meaning they might have mild memory issues due to Alzheimer's (often called mild cognitive impairment) or mild Alzheimer's dementia.

The main aim of the research is to see if Trontinemab can help with the symptoms of early Alzheimer's and if it is safe to use. Researchers are comparing Trontinemab to a 'placebo', which is an inactive substance that looks just like the real medication. This comparison helps them understand if any changes seen in participants are truly due to Trontinemab or other factors.

Finding new, safe, and effective treatments for Alzheimer's disease is incredibly important. Studies like this help medical professionals learn more about the illness and develop better ways to support people living with it. Your involvement could contribute significantly to our understanding and potential future treatments.

Key takeaways

  • The study investigates a new drug, Trontinemab, for early Alzheimer's disease.
  • It aims to check if Trontinemab is safe and effective in slowing down Alzheimer's symptoms.
  • Participants will receive either Trontinemab or an inactive placebo.
  • A 'study partner' is required to support participants during the trial.
  • Careful assessments, including brain scans and memory tests, will be part of the study.
  • You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you would generally need to be between 50 and 90 years old and have been diagnosed with early Alzheimer's disease, or be experiencing mild memory problems thought to be due to Alzheimer's.

Researchers will need to confirm that changes in your brain are indeed linked to Alzheimer's, often through special scans. You'll also need to have someone, like a family member or close friend, who can act as a 'study partner' to help you throughout the study. Your memory and thinking abilities will be assessed to make sure you fit the study's specific criteria.

Not everyone can join, even if they have early Alzheimer's. For example, if you have other significant medical conditions that aren't well controlled, or if previous brain issues like a stroke or serious head injury could interfere with the study's results, you might not be suitable. A research doctor will carefully review your health to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 50 and 90 years old?
  2. Do you have early Alzheimer's disease or mild memory difficulties likely due to Alzheimer's?
  3. Do you have a family member or close friend who could be your 'study partner'?
  4. Are you generally in good health apart from your Alzheimer's diagnosis?
  5. Have you had brain scans that show evidence of Alzheimer's-related changes?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either Trontinemab or a placebo. This would involve regular visits to the study clinic for check-ups, assessments of your memory and thinking, and scans like MRI to look at your brain. You might also have blood tests and spinal fluid tests (if appropriate and agreed upon) to help understand the disease and the treatment's effects. Your study partner would need to be available to attend some appointments with you and provide information about your memory and daily life. The exact number of visits and the total duration aren't specified here, but clinical trials usually involve a commitment over several months to a few years, with careful follow-up throughout.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and contributing to medical research that could help others. However, there are also potential risks, including side effects from the study medication or procedures, which would be fully explained before you agree to take part. There's also no guarantee that the treatment will work for you. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (143)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham
    Verified postcode
    Birmingham, United States· Recruiting
  • Banner Sun Health Research Institute
    Verified postcode
    Sun City, United States· Recruiting
  • Irvine Center for Clinical Research
    Verified postcode
    Irvine, United States· Recruiting
  • Inglewood Clinicals
    Verified postcode
    Los Angeles, United States· Recruiting
  • UCSF - Memory and Aging Center
    Verified postcode
    San Francisco, United States· Recruiting
  • Syrentis Clinical Research
    Verified postcode
    Santa Ana, United States· Recruiting
  • K2 Medical Research - The Villages
    Verified postcode
    Lady Lake, United States· Recruiting
  • K2 Medical Research, LLC
    Verified postcode
    Maitland, United States· Recruiting
  • Renstar Medical Research
    Verified postcode
    Ocala, United States· Recruiting
  • Axiom Brain Health LLC
    Verified postcode
    Tampa, United States· Recruiting
  • Charter Research - Lady Lake/The Villages
    Verified postcode
    The Villages, United States· Recruiting
  • Alzheimer?s Research and Treatment Center
    Verified postcode
    Wellington, United States· Recruiting

Common questions

What is Trontinemab?

Trontinemab is an investigational medication being studied to see if it can help people with early Alzheimer's disease.

What is a placebo?

A placebo is a substance that looks exactly like the study medication but does not contain any active drug. It helps researchers compare the effects of the new treatment.

What does 'early symptomatic Alzheimer's disease' mean?

It refers to the beginning stages of Alzheimer's, where symptoms like memory or thinking problems are noticeable, ranging from mild cognitive impairment to mild dementia caused by Alzheimer's.

Who is a 'study partner'?

A study partner is typically a trusted family member or close friend who knows you well and can help you with study appointments and provide information about your health and daily life.

Will I know if I'm getting Trontinemab or the placebo?

In most studies, participants (and often the doctors) don't know who is receiving the active drug versus the placebo. This helps ensure unbiased results.

How to find out more

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

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Trontinemab in Participants With Early Symptomati…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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