Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

I5T-MC-AACQ: Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults with Early Symptomatic Alzheimer’s Disease

This important study, known as I5T-MC-AACQ, is investigating a new treatment called donanemab for people in the early stages of Alzheimer's disease. Researchers want to see if giving different doses of donanemab can help reduce amyloid, a specific protein that builds up in the brains of people with Alzheimer's. They are also carefully watching for any brain swelling or fluid build-up, called ARIA-E, which can sometimes be a side effect of this type of medication. The study aims to find the safest and most effective way to use donanemab to treat this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

07 Apr 2023

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

What is this study about?

This study is investigating a new treatment called donanemab for people who are in the early stages of Alzheimer's disease. Alzheimer's is a condition that affects memory, thinking, and daily activities. One of the main things found in the brains of people with Alzheimer's is a build-up of a protein called 'amyloid'. Medications like donanemab are designed to help clear this amyloid protein from the brain.

The main goal of this particular study is to understand how different ways of giving donanemab affect two key things. Firstly, it wants to see how well donanemab can reduce the amyloid protein in the brain. Secondly, and very importantly, it's carefully looking at a potential side effect called ARIA-E. ARIA-E stands for 'Amyloid-Related Imaging Abnormality - Edema/Effusion', which means swelling or fluid build-up in the brain that can be seen on special scans. The study uses a special scan fluid called Neuraceq to help doctors see the amyloid in the brain more clearly.

By comparing different dosing plans, researchers hope to find the best balance – where the drug is effective at clearing amyloid but causes the least amount of ARIA-E, making it safer for patients. The study is in Phase III, which means it’s a big, final stage of testing before a new treatment might become more widely available. It's a crucial step in understanding how to best use donanemab to help people with early Alzheimer's.

Key takeaways

This study is testing a drug called donanemab for early Alzheimer's disease.
It aims to see how well donanemab clears amyloid protein from the brain.
Researchers are carefully monitoring for a side effect called ARIA-E (brain swelling).
The goal is to find the safest and most effective way to use donanemab.
The study is for adults with early symptoms of Alzheimer's.
Participation involves regular clinic visits and brain scans.

Who may be eligible?

This study is looking for adults who have been diagnosed with early Alzheimer's disease. Both men and women are welcome to take part.

To be considered, you would need to have been recently diagnosed with Alzheimer's and be experiencing symptoms that are still in the early stages. This isn't a study for people who are perfectly healthy or those with very advanced Alzheimer's.

The medical team will do tests to confirm that you have amyloid protein in your brain, as this is what the study drug targets. They will also make sure that taking part in the study is safe for you based on your overall health.

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 an adult aged 18 or over?
Have you been diagnosed with Alzheimer's disease?
Are your Alzheimer's symptoms considered early or mild?
Are you able to attend regular appointments for treatment and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study drug, donanemab, or a salt water solution (placebo) through a drip, usually into your arm. You would need to attend regular appointments at the study clinic. These visits will involve blood tests, physical check-ups, and special brain scans to see how the treatment is working and to check for any side effects like ARIA-E.

During these visits, doctors will closely monitor your health and how you are responding to the treatment. They will also look at how the amyloid in your brain is changing over time. The total length of your involvement in the study, including the treatment and follow-up, would be discussed clearly with you, but typically these types of studies run for a period of months to a few years.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing a new treatment before it's widely available. Researchers learn valuable information that could help others in the future. However, there are potential risks, including side effects from the study drug like brain swelling (ARIA-E), or from the procedures involved. Not everyone receives the active drug, as some participants may receive a placebo. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is donanemab?

Donanemab is a drug being tested to treat Alzheimer's disease. It works by trying to clear a specific protein called amyloid from the brain.

What is ARIA-E?

ARIA-E stands for 'Amyloid-Related Imaging Abnormality - Edema/Effusion'. It's a potential side effect where there is swelling or fluid in the brain that doctors look for on scans.

Why are different doses being studied?

Researchers want to find the best amount of donanemab to give – enough to be effective at clearing amyloid, but with the fewest possible side effects like ARIA-E.

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

This means you've been diagnosed with Alzheimer's and are experiencing symptoms, but these symptoms are not yet severe, and you are in the earlier stages of the illness.

Will I definitely receive the study drug?

In some studies, participants may receive the active drug or a placebo (a dummy treatment). Your study doctor will explain what to expect for this particular trial.