Active not recruitingPHASE3INTERVENTIONAL

DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease

This study is for people with a rare, inherited form of Alzheimer's disease who previously took part in another study called DIAN-TU-001. We're looking at a new drug called lecanemab to see how well it removes sticky amyloid plaques from the brain. These plaques are thought to be a key cause of Alzheimer's. The main goals are to find out if lecanemab can fully clear these plaques, whether this helps to delay when symptoms start, and if it slows down the disease's progress. We're also studying how the drug affects other signs of the disease in the body. This research is important for understanding both inherited and more common forms of Alzheimer's.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Washington University School of Medicine

Enrolment target

Start

10 Jun 2024

Estimated completion

01 Jun 2030

Alzheimer's Disease Dementia Alzheimer's Disease, Familial

What is this study about?

This study builds on a lot of important research that has been going on for over ten years within the Dominantly Inherited Alzheimer Network (DIAN). We've learned a great deal about inherited Alzheimer's disease, and this has helped us understand the more common forms of Alzheimer's too. Many people in this new study have previously taken part in another trial where they received a different drug called gantenerumab for a long time, some for up to ten years.

Now, as that previous study is ending, there's a need to continue monitoring and treating these individuals. This new study offers participants the chance to receive a different drug, lecanemab, which is designed to remove amyloid plaques from the brain. Amyloid plaques are sticky clumps of protein that are believed to build up in the brains of people with Alzheimer's, leading to memory and thinking problems.

The main reasons for doing this study are to see if lecanemab can fully get rid of these amyloid plaques, if removing them can delay the start of symptoms or slow down the disease's progression, and how it affects other important signs of the disease. The information we gather will help us understand the best ways to treat Alzheimer's, including how much of a drug to give, for how long, and for which people, ultimately aiming to find treatments that work best for patients.

Key takeaways

This study uses a drug called lecanemab to remove amyloid plaques in people with inherited Alzheimer's.
It's for people who previously took part in the DIAN-TU-001 study.
The main goal is to see if removing amyloid can slow disease progression and delay symptom onset.
Participation involves regular drug infusions, brain scans, and other health checks.
The study aims to provide important insights for both inherited and common forms of Alzheimer's disease.

Who may be eligible?

This study is specifically designed for people who have already taken part in the DIAN-TU-001 gantenerumab study. You'll need to be willing to continue treatment aimed at removing amyloid from the brain. If you're a woman who could get pregnant, or have a partner who could, you'll need to agree to use effective contraception throughout the study.

You also need to be part of an ongoing study called the DIAN Observational Study and be happy to complete its checks. It's important that you can have regular brain scans (MRIs) and that your veins are suitable for receiving study medication.

There are also some reasons why you might not be able to join. For example, if you have certain types of brain changes seen on scans that could make taking the study drug risky, or if you have a history of serious brain bleeds. Conditions like uncontrolled high blood pressure, severe seizures, ongoing immune system problems, or needing certain blood-thinning medications might also mean you can't take part. The study team will carefully check all of these factors to make sure it's safe for you.

Quick self-check

Did I previously take part in the DIAN-TU-001 gantenerumab study?
Am I willing to continue anti-amyloid treatment?
Am I already enrolled in the DIAN Observational Study?
Can I have regular MRI scans (brain scans)?
Do I have any serious heart conditions, uncontrolled blood pressure, or major bleeding issues?
If I could become pregnant, am I willing to use effective contraception?

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 will be given a drug called lecanemab. This drug is given through a drip into your arm (an infusion). You'll have regular visits to the clinic for these infusions and for various tests. These tests will include brain scans (MRI and PET scans) to check the amyloid levels in your brain and to make sure the treatment is safe. You will also have blood tests and other assessments to monitor your health and how the disease is progressing. The total duration of your participation will depend on how you respond and the study's overall timeline, but it is designed to continue the treatment and monitoring you've been receiving.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as continuing a treatment that aims to remove amyloid plaques from your brain, which might help slow the progression of inherited Alzheimer's disease. However, there are also potential risks, including side effects from the study drug like brain swelling or small bleeds, which will be carefully monitored with regular scans. You will be fully informed about all known risks and side effects before you decide to join. It is very important to remember that joining a study is always your choice, and you are free to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (6)

University of Alabama in Birmingham
Birmingham, United States
Indiana University School of Medicine
Indianapolis, United States
Washington University in St. Louis
St Louis, United States
University of Washington
Seattle, United States
Neuroscience Research Australia
Randwick, Australia
The National Hospital for Neurology and Neurosurgery
London, United Kingdom

Common questions

What is 'amyloid removal'?

Amyloid removal refers to using a special drug to help clear away sticky clumps of protein called amyloid plaques that build up in the brain of people with Alzheimer's disease.

What is lecanemab?

Lecanemab is the name of the drug being tested in this study. It's designed to target and help remove amyloid plaques from the brain.

Why is this study only for people who were in a previous study?

This study is designed to continue the care and monitoring for a very specific group of individuals who have a rare, inherited form of Alzheimer's and have been involved in long-term amyloid-reducing treatment already.

What is the difference between inherited and regular Alzheimer's?

Inherited Alzheimer's is a very rare form caused by a specific gene fault that runs in families, often causing symptoms at a younger age. Regular Alzheimer's (sporadic) is far more common and usually develops later in life, without a single clear genetic cause.

Will I know if the drug is working?

The study team will monitor your progress through various scans and tests. While they can tell if amyloid is being removed, they cannot guarantee a specific outcome regarding your symptoms or disease progression.