Active not recruitingPHASE3INTERVENTIONAL

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

This study, called TRAILBLAZER-ALZ 2, is investigating a new medication, donanemab, for people with early Alzheimer's disease. The main goal is to see how safe it is and how well it works. Participants will either receive donanemab or a placebo (a dummy treatment, which looks the same but has no active medicine) in the main part of the study. Some additional participants will receive donanemab to help understand its safety better. After the main treatment period, some people will be followed for a longer time to see how they are doing. This helps researchers understand the long-term effects of the medicine on Alzheimer's.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,736

Start

19 Jun 2020

Estimated completion

01 Nov 2028

Alzheimer Disease

What is this study about?

This study is designed to learn more about a new medicine called donanemab. It's for people who are in the early stages of Alzheimer's disease. Researchers want to find out if this medicine can help slow down the disease and if it's safe to use.

For the main part of this study, participants will be split into groups. Some will receive the new medicine, donanemab, and others will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This is a common way to test new treatments, as it helps doctors understand if any changes are truly due to the medicine or just to other factors. Neither you nor your study doctor will know which treatment you are receiving until the main part of the study is over.

After the main study, there will be an extra period where some participants who had donanemab will be monitored for up to three years. This is to see how their condition develops over a longer time without continuous treatment. There's also a separate, smaller group of participants who will all receive donanemab from the start, purely to gather more information on the medicine's safety. This all helps build a full picture of how donanemab might help people with Alzheimer's.

Key takeaways

This study is testing a new medicine, donanemab, for early Alzheimer's disease.
It aims to see if donanemab is safe and effective.
Participants will receive either donanemab or a placebo.
Regular visits, blood tests, and brain scans are part of the study.
A supportive 'study partner' is required.
The total involvement could last several years.

Who may be eligible?

To join this study, people generally need to be between 60 and 85 years old. They should have noticed a gradual change in their memory that has been getting worse for at least six months, and this change should also be noticed by someone close to them. People would also need to have certain changes in their brain scans that are linked to Alzheimer's disease. It's really important that participants have a 'study partner' – this is someone like a family member or close friend who knows them well and can help provide information about their memory and daily life throughout the study.

There are also some reasons why someone might not be able to join. For example, if they can't have certain types of brain scans (like an MRI or PET scan), or if they are currently receiving a specific kind of immune treatment called IgG therapy. The study doctors will carefully check if someone is suitable based on all these criteria.

Quick self-check

Are you between 60 and 85 years old?
Have you noticed your memory changing gradually for at least 6 months?
Does a close family member or friend also notice these memory changes?
Do you have a family member or friend willing to be your 'study partner'?
Are you able to have MRI and PET brain scans?
Are you currently not receiving a specific immune treatment called IgG therapy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would receive the study medicine (donanemab or a placebo) through an IV drip over regular visits for about 76 weeks (around 1.5 years). You would have regular check-ups, blood tests, and special brain scans called PET scans and MRI scans. After this main treatment part, some participants who received donanemab might be asked to continue in a follow-up period for up to three years. During this follow-up, you wouldn't receive any more study medicine but would have regular check-ups and scans to see how your brain is doing. The total time you could be involved in the study, including any follow-up, could be several years.

Potential risks and benefits

Participating in a clinical trial like this may offer some potential benefits, such as receiving a new investigational treatment for Alzheimer's disease and close medical monitoring. However, there are also potential risks, including side effects from the medication or the various tests. Your memory changes might not improve, or they could get worse. It is important to remember that all participants have the right to withdraw from the study at any time, for any reason, without it affecting their usual medical care.

Locations (274)

Gilbert Neurology
Gilbert, United States
Xenoscience
Phoenix, United States
Banner Alzheimer's Institute
Phoenix, United States
Perseverance Research Center
Scottsdale, United States
Banner Sun Health Research Institute
Sun City, United States
Banner Alzheimer's Institute Tucson
Tucson, United States
Center for Neurosciences
Tucson, United States
Health Initiatives Research
Fayetteville, United States
North County Neurology Associates
Carlsbad, United States
Wr- Pri, Llc
Encino, United States
Neuro-Pain Medical Center
Fresno, United States
Neurology Center of North Orange County
Fullerton, United States

+262 more sites — see the official record for the full list.

Common questions

What is donanemab?

Donanemab is a new medicine being tested for people with early Alzheimer's disease. It aims to remove certain proteins from the brain thought to be involved in the disease.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active ingredients. It's used to see if the real medicine is truly effective.

Why do I need a 'study partner'?

A study partner (like a family member or friend) can provide important information about your memory and how you're managing day-to-day, which helps researchers understand the medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of the study, neither you nor your doctor will know. This is called 'double-blind' and helps ensure the results are fair and accurate.

What are PET and MRI scans?

These are special types of brain scans that allow doctors to see detailed pictures of your brain, which helps them understand Alzheimer's disease and how it might be affected by the treatment.