Active not recruitingPHASE3INTERVENTIONAL

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

This research study, called TRAILBLAZER-ALZ 6, is investigating a medicine called donanemab for people in the early stages of Alzheimer's disease. The main goal is to find out if giving donanemab in different ways (different amounts or schedules) changes the likelihood or severity of a specific side effect called ARIA-E. Researchers also want to understand if there are certain things about a person that might make them more likely to get this side effect. Approximately 375 people will join this study, which will last about 91 weeks, involving up to 26 visits. Participants will be aged between 60 and 85, and anyone with early Alzheimer's disease might be considered.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,175

Start

28 Feb 2023

Estimated completion

01 May 2027

Alzheimer's Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

What is this study about?

This study is about a medicine called donanemab for people who are in the early stages of Alzheimer's disease. Alzheimer's is a common cause of dementia, a brain condition that affects memory and thinking. Researchers are trying to find new and better ways to treat it, and donanemab is one of these experimental medicines.

The main aim of this particular study is to explore different ways of giving donanemab. Think of it like trying different dosages or schedules for a medicine – the study wants to see which approach works best, especially in terms of side effects. Specifically, they are looking at a side effect called ARIA-E, which can sometimes happen with this type of treatment. They want to understand if giving different amounts of the medicine, or giving it at different times, changes how often this side effect occurs or how serious it might be.

Another important part of this study is to learn more about the people taking the medicine. Researchers are trying to figure out if there are certain things about an individual – like their age, or other health conditions – that might make them more or less likely to experience the ARIA-E side effect. By understanding this, doctors might be able to better predict who could be at higher risk in the future, helping to make treatments safer and more personalised.

Key takeaways

This study is for adults aged 60-85 with early Alzheimer's disease.
It's testing different doses of an experimental medicine called donanemab.
The main goal is to understand how different ways of giving the medicine affect a side effect called ARIA-E.
The study lasts nearly two years and involves around 26 clinic visits.
Participants will receive either donanemab or a placebo.
Regular health checks and brain scans (MRI, PET) will be part of the process.

Who may be eligible?

To join this study, people generally need to be between 60 and 85 years old. You would need to have noticed gradual changes in your memory for at least six months, and some tests would show that you are in the early stages of Alzheimer's disease. A special scan, called an amyloid PET scan, would also need to show that you have specific changes in your brain linked to Alzheimer's.

There are also reasons why someone might not be able to join. For example, if you have other serious brain conditions, like other types of dementia, or certain major health problems affecting your heart, kidneys, lungs, or other body systems, you might not be eligible. If you have had certain cancers recently, or if you can't have MRI or PET scans, you also wouldn't be able to take part. Also, if you’ve already had a similar type of treatment for Alzheimer’s, you wouldn’t be able to join this particular study.

Quick self-check

Am I between 60 and 85 years old?
Have I or my family noticed my memory getting worse gradually for at least 6 months?
Have I had a scan that shows brain changes linked to Alzheimer's?
Do I have any other major brain conditions apart from early Alzheimer's (like other types of dementia or Parkinson's)?
Do I have any serious or unstable health problems that could affect my participation?
Can I have MRI and PET scans safely?

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

What does participation involve?

If you decide to take part in this study, it will involve quite a few visits over a period of about 91 weeks, which is roughly a year and nine months. During this time, you could have up to 26 visits to the clinic.

At these visits, you will have various assessments to check your memory and thinking, as well as your general health. You’ll receive either the study medicine, donanemab, or a placebo (an inactive substance that looks just like the study medicine). Neither you nor your doctor will know which one you are receiving. You might also receive another medicine called dexamethasone, which is sometimes used to manage side effects. You will have regular brain scans, like MRI and PET scans, to monitor the effects of the treatment and check for any changes.

After the main treatment period, there will be follow-up visits to ensure your safety and monitor your health over time. The study team will explain everything in detail, and you'll have plenty of opportunities to ask questions.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from closer medical attention and access to a new experimental medicine that could help with early Alzheimer's, though there's no guarantee it will work for you. Donanemab, like all medicines, can have side effects. One specific side effect the study is closely monitoring is called ARIA-E, which involves swelling or small bleeds in the brain, though medicines like dexamethasone may be given to help manage it. Other potential risks include side effects from blood tests, scans, or other procedures. You will be fully informed about all known risks and benefits before deciding to join, and importantly, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

MD First Research - Chandler
Chandler, United States
Irvine Clinical Research
Irvine, United States
Healthy Brain Clinic
Long Beach, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, United States
JEM Research Institute
Atlantis, United States
VIN-Julie Schwartzbard
Aventura, United States
Excel Medical Clinical Trials
Boca Raton, United States
K2 Medical Research
Clermont, United States
Brain Matters Research
Delray Beach, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, United States
Finlay Medical Research
Greenacres City, United States
Infinity Clinical Research, LLC
Hollywood, United States

+37 more sites — see the official record for the full list.

Common questions

What is donanemab?

Donanemab is an experimental medicine being studied for early Alzheimer's disease. It aims to clear certain brain changes (amyloid plaques) thought to be involved in the disease.

What is ARIA-E?

ARIA-E is a specific side effect that can sometimes happen with medicines like donanemab. It stands for 'Amyloid-Related Imaging Abnormalities - Edema' and means there can be some swelling or small bleeds in the brain, which are usually seen on scans.

What is a placebo?

A placebo is a substance that looks exactly like the study medicine but doesn't actually contain any active drug. It helps researchers compare the effects of the real medicine to simply taking something, without knowing which it is.

How long will the study last?

The study will last for about 91 weeks, which is just under two years, and will involve up to 26 visits during that time.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason. Your decision will not affect your future medical care.