A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
This research study is investigating a new treatment called Trontinemab. It's for people who show signs in their body that they might develop Alzheimer's disease in the future, even though they don't have any memory or thinking problems right now. The main aim is to find out if Trontinemab is safe to use and if it can prevent or delay the onset of memory issues associated with Alzheimer's disease. Participants will be compared to a group receiving a 'placebo' (a dummy treatment). This is a 'Phase 3' study, meaning it's a larger study designed to confirm earlier findings and check the medication's effectiveness and safety in more detail before it could potentially be made widely available.
At a glance
What is this study about?
This research study is about a new medicine called Trontinemab, which we hope could help people at risk of Alzheimer's disease. Alzheimer's is a condition that affects memory and thinking. Sometimes, before people start showing noticeable symptoms like memory loss, their bodies can show early signs of the disease. This study is for individuals who have these early signs but are still living their daily lives without any problems with their memory or thinking.
The main goal of the study is to see if Trontinemab can help stop or slow down the progression of Alzheimer's disease in these individuals. We want to find out if taking this medication can prevent them from developing milder memory problems (sometimes called mild cognitive impairment) or more advanced Alzheimer's disease later on. This is a crucial step in understanding if this new treatment could offer hope for preventing the disease.
Participants will be split into different groups. Some will receive Trontinemab, and others will receive a 'placebo' – a substance that looks exactly like the study medicine but contains no active drug. This allows researchers to compare the two groups fairly and see if Trontinemab truly makes a difference beyond what might happen naturally or with a dummy treatment. It's a 'Phase 3' study, which means it's one of the final and largest stages of research before a new medicine might be considered for wider use.
Key takeaways
- This study is testing a new drug (Trontinemab) to prevent Alzheimer's symptoms.
- It's for people aged 55-80 who are at risk but have no memory problems yet.
- You might receive the new drug or a dummy treatment (placebo).
- Regular clinic visits, tests, and a study partner are needed.
- Participation is voluntary, and you can leave at any time.
- Always discuss any concerns with your doctor.
Who may be eligible?
This study is looking for volunteers aged between 55 and 80. To take part, you must not have any memory problems or difficulties with daily activities at the moment. However, tests will show that you have certain markers in your body that suggest you are at a higher risk of developing Alzheimer's disease in the future.
There are also some things that would mean you couldn't join. For example, if you already have any form of memory impairment, or a diagnosis of any other condition that affects thinking or memory (like Parkinson's disease, dementia with Lewy bodies, or a history of stroke), you wouldn't be able to participate. We also need to make sure you're generally well enough to take part and attend all appointments.
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.
- Are you between 55 and 80 years old?
- Do you currently have no memory or thinking problems?
- Are you generally healthy enough to take part in a study?
- Could you attend regular appointments and complete study activities?
- Do you have a friend or family member who could be your 'study partner'?
- Are you able to manage your weight to be 150 kg or less?
What does participation involve?
If you decide to take part, you'll be involved in the study for a period of time, which will include regular visits to the clinic. At these visits, you'll have various assessments such as memory and thinking tests, blood tests, and possibly brain scans. You will also receive the study medication (either Trontinemab or a placebo) as directed by the study team. You'll need to have a 'study partner' – someone close to you who can attend some appointments with you and provide information about your daily life. The research team will explain the full schedule and what each visit involves. The exact total duration of your participation will be fully explained before you agree to join.
Potential risks and benefits
Locations (7)
- Irvine Center for Clinical ResearchVerified postcodeIrvine, United States· Recruiting
- Syrentis Clinical ResearchVerified postcodeSanta Ana, United States· Recruiting
- K2 Medical Research, LLCVerified postcodeMaitland, United States· Recruiting
- Basil ClinicalVerified postcodeLaurelton, United States· Recruiting
- Toronto Memory ProgramVerified postcodeToronto, Canada· Recruiting
- Xuanwu Hospital, Capital Medical UniversityVerified postcodeBeijing, China· Recruiting
- Surrey and Borders NHS Foundation TrustVerified postcodeChertsey, United Kingdom· Recruiting
Common questions
What is Trontinemab?
Trontinemab is a new medication being tested in this study to see if it can help prevent or delay Alzheimer's disease in people who are at risk but don't have symptoms yet.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medication's effects.
Why do I need to be 'cognitively unimpaired'?
This study focuses on preventing Alzheimer's before symptoms start. So, participants must not have any memory or thinking problems when they join.
What does 'biomarker evidence' mean?
This refers to specific tests, like blood tests, that show early signs in your body suggesting you might be at a higher risk of developing Alzheimer's disease.
What is a 'study partner'?
A study partner is a trusted friend or family member who knows you well and can attend some appointments to help provide information about your health and daily life to the study team.
How to find out more
Reference Study ID Number: WN46072 https://forpatients.roche.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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