Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Amyloid Removal Trial (ART): A Phase IIIb/IV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimer’s Disease

This research study, called the DIAN-TU ART trial, is exploring a new medicine called lecanemab. It's for individuals who have a specific, inherited type of Alzheimer's disease. The main goal is to understand if lecanemab can help prevent the disease from starting or slow its progression. Researchers will look for changes in the brain using special scans and also monitor memory and thinking abilities over several years. The study wants to see how well the drug works by checking levels of a substance called amyloid in the brain. They will also look at how people's daily living skills and memory change over time. This study is designed to gather important information about future treatments for this condition.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Washington University School Of Medicine

Enrolment target

Start

11 Oct 2024

Dominantly Inherited Alzheimer Disease (DIAD)

What is this study about?

This study focuses on a specific type of Alzheimer's disease that runs in families, known as Dominantly Inherited Alzheimer's Disease (DIAD). This form of Alzheimer’s is caused by a faulty gene passed down through generations. People with DIAD often develop symptoms at a younger age than those with more common forms of Alzheimer's.

The research is testing a new drug called lecanemab. Scientists believe that Alzheimer's disease is linked to a build-up of certain substances in the brain, especially one called amyloid. Lecanemab is designed to help clear this amyloid. The study aims to find out if this medication can either stop the disease from developing in people at risk or slow down its effects in those who are starting to show symptoms.

Researchers will use various methods to see if lecanemab is working. This includes special brain scans that can spot amyloid, and tests that check how well people are thinking, remembering, and performing daily tasks. By closely monitoring these changes over several years, the study hopes to provide valuable insights into future treatments for DIAD.

Key takeaways

This study is for people with a rare, inherited type of Alzheimer's disease.
It tests a new drug, lecanemab, to see if it can prevent or slow the disease.
Researchers will monitor brain changes and memory/thinking abilities.
Participation involves regular clinic visits for tests and drug infusions.
It's a long-term study aiming to find better treatments for DIAD.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. Both men and women can take part.

Crucially, you must have been diagnosed with Dominantly Inherited Alzheimer's Disease (DIAD). This means you have a specific gene fault that causes this type of Alzheimer’s to run in your family. The study is particularly looking for individuals who either haven't developed symptoms yet but are at high risk, or those who are in the very early stages of the disease.

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 18 years old or older?
Have you been diagnosed with Dominantly Inherited Alzheimer's Disease (DIAD)?
Did a doctor confirm you have the specific gene faulty gene for DIAD?
Are you able to attend regular clinic appointments for tests and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have regular visits to a study clinic. These visits will involve various tests and assessments. You'll likely have special brain scans (like PET scans) to check for changes in your brain, specifically looking at substances like amyloid. There will also be tests to assess your memory, thinking skills, and your ability to carry out everyday activities. Blood and spinal fluid samples may also be collected to measure certain markers related to the disease. You would receive the study drug, lecanemab, likely through an infusion, during these visits. The study involves long-term follow-up, potentially for several years, to track any changes over an extended period. The full duration of your participation would be explained in detail.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as access to a new experimental treatment (lecanemab) that isn't widely available. Your involvement also contributes significantly to our understanding of inherited Alzheimer's and could help develop better treatments for future generations. However, there are potential risks, as with any medication. These could include side effects from the drug or discomfort from procedures like blood tests or scans. All possible risks would be explained clearly. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
France

Common questions

What is Dominantly Inherited Alzheimer's Disease (DIAD)?

DIAD is a rare form of Alzheimer's caused by a specific faulty gene passed down through families, leading to earlier onset of symptoms.

What is lecanemab?

Lecanemab is a trial medication designed to target and help clear amyloid, a protein thought to build up in the brains of people with Alzheimer's disease.

What kind of tests will I have?

You might have brain scans (like PET scans), memory and thinking tests, and blood or spinal fluid tests to check for changes related to the disease.

How long will the study last?

This study involves long-term follow-up, potentially over several years, to closely monitor any changes related to the treatment.

Can I stop participating in the study if I change my mind?

Yes, you are free to leave the study at any point, and doing so will not affect your future medical care.