Project details

Summary

What is the study about?

Alzheimer’s disease (AD) is a slowly developing disease of the brain that affects memory and other brain functions. It is a disease in which accumulation of protein material called beta-amyloid plaques (amyloid beta) occurs in the brain. Therefore, treatment that helps to prevent or decrease the accumulation of amyloid beta is being tested as possible treatment in AD. 

This study is testing a drug called trontinemab.  Trontinemab combines an anti-amyloid antibody with a module which helps to more efficiently deliver the antibody to the brain.  Trontinemab works by preventing, blocking, and/or reducing the accumulation of beta-amyloid plaques in the brain.  

Trontinemab is an experimental drug, which means health authorities have not approved trontinemab for the treatment of AD or any other disease. 

What are you trying to find out?

The purpose of this study is to compare the effects, good or bad, of trontinemab versus placebo on participants with Alzheimer's Disease (AD). In this study, you will receive either trontinemab or placebo. A placebo looks like a drug but has no active ingredient. 

This study will take place in around 25 countries. Approximately 40 participants will take part in the study in the UK and 800 worldwide. 

Who is it for?

We are looking for participants who have mild dementia due to Alzheimer’s disease (AD) or early symptoms of AD, known as mild cognitive impairment.

You will need a study partner who will be able to accompany you to clinic visits, to answer some questions about you. Their participation is mandatory for visits that include completion of questionnaires. A study partner is someone who regularly spends time face-to-face with you - perhaps around five times a week, or for about ten hours weekly - such as a family member, friend, a social worker, or a case worker. We're looking for someone who sees you often enough to have a good understanding of you day-to-day life. The study partner will be reimbursed for travel & refreshment costs. They may also receive an amount (based on the national living wage) for each visit. 

What does taking part involve?

Screening: You will be asked to undergo some screening tests to check your eligibility for the study.

Treatment Period: If eligible, you will undergo further tests as described in the Main Participant Information Sheet (PIS). You will receive trontinemab or placebo as an infusion into the vein initially every month (for approximately the first 6 months) and then every 3 months, until the end of treatment.

Your study doctor will carefully monitor you while you are being given the study drug and for some time afterwards to check any reaction to the study drug. Your study doctor will discuss this with you further and go through the Main PIS with you. 

Study Duration: Your total time in the study will be about 80 weeks (approximately 1 year and 7 months). 

During this study, you will have at least 15 visits. Your total time in the study will be about 80 weeks (approximately 1 year and 7 months). 

You can find out more information about taking part in this study by downloading the key documents at the top of this page.

Why is it important?

The information that is learned may help other people who have a similar medical condition in the future. 

How can I find out more?

You can find out more information about taking part in this study by downloading the key documents at the top of this page.

If you are interested in taking part in this study, or have questions for the research team, click the button below to email us:

Email the research team