RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)

This research, called the ABATE Study, is testing a new medication called ACI-24.060. It's designed to see how safe the medication is, how the body reacts to it, and what effects it has on people. The study includes two main groups: individuals in the very early stages of Alzheimer's disease (known as prodromal Alzheimer's) and adults with Down Syndrome who are showing signs of Alzheimer's. The focus is on amyloid plaques, which are tiny clumps of protein that build up in the brain and are linked to Alzheimer's. This study is an important step in developing new ways to potentially treat or prevent these conditions by looking at how well the new medication works and if it's safe for people to take.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AC Immune SA

Enrolment target

304

Start

21 Jun 2022

Estimated completion

01 Apr 2029

Amyloid Plaque Beta-Amyloid DSAD Prodromal Alzheimer's Disease Alzheimer's Disease

What is this study about?

This study, called the ABATE Study, is looking into a new treatment called ACI-24.060. The main goal is to understand if this new medication is safe for people to take and how it affects the body. Researchers are particularly interested in how it might impact the buildup of 'amyloid plaques' in the brain. These plaques are sticky clumps of protein that are thought to play a big part in the development of Alzheimer's disease.

The study involves two different groups of people. One group includes individuals who are in the very early stages of Alzheimer's disease, sometimes called 'prodromal Alzheimer's.' This means they might have mild memory problems, but they are not yet fully diagnosed with Alzheimer's dementia. The other group includes adults with Down Syndrome who show early signs of Alzheimer's disease.

By carefully studying these groups, researchers hope to learn if ACI-24.060 could be a helpful way to prevent or slow down the progression of Alzheimer's. This kind of research is really important because it helps us find new and better ways to tackle challenging conditions like Alzheimer's. The study will also look at different doses of the medication to find the most effective and safest one.

Key takeaways

This study is testing a new drug for early Alzheimer's and Down Syndrome related Alzheimer's signs.
It aims to check the medication's safety and how it affects amyloid plaques in the brain.
Participation involves regular clinic visits, assessments, and receiving either the study drug or a placebo.
The study includes different age groups and conditions, with specific health requirements.
Having a study partner is important for individuals with Down Syndrome in the trial.
You can stop participating at any time without affecting your usual medical care.

Who may be eligible?

To be considered for this study, you would need to fit certain criteria. If you have early signs of Alzheimer's disease, you should be between 50 and 85 years old. Doctors would need to confirm you have what's called 'prodromal Alzheimer's disease,' and scans would show amyloid plaques in your brain. You might already be taking approved Alzheimer's medication, as long as it's been at a steady dose for at least two months.

If you have Down Syndrome, you would need to be between 35 and 50 years old, with a confirmed genetic diagnosis of Down Syndrome. Similar to the other group, scans would need to show amyloid plaques in your brain. You should also have mild to moderate intellectual disability. For participants with Down Syndrome, it's also important to have a 'study partner,' someone who knows you well and can help answer questions about you during the study.

There are also some reasons why you might not be able to join. For example, if you have any serious or unstable medical conditions that could make it difficult to take part safely, or if you've had substance use issues in the last five years (excluding smoking), you might not be eligible. The study team will review all your health information carefully to make sure it's the right choice for you.

Quick self-check

Are you between 50 and 85 years old with early signs of Alzheimer's (prodromal)?
Are you between 35 and 50 years old with Down Syndrome and signs of Alzheimer's?
Do brain scans show that you have amyloid plaques?
If you have Down Syndrome, do you have a trusted person (study partner) who knows you well?
Do you have any serious medical conditions that might interfere with participating safely?

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

What does participation involve?

Taking part in this study would involve several visits to the study clinic over a period of time. You would receive either the new medication, ACI-24.060, or a placebo, which looks like the study medication but contains no active drug. Placebos are used so researchers can accurately compare the effects of the new medication. There are different doses being tested, and some parts of the study might involve a special booster to help the medication work.

During your visits, you would have various assessments. This includes regular health checks, blood tests, and special brain scans (PET scans) to look at the amyloid plaques. You might also complete memory and thinking tests to see how your brain function changes over time. For those with Down Syndrome, your study partner will also be involved in answering questions about your daily life and abilities. The specific number of visits and the total duration of your participation will depend on which part of the study you are in, and this will be fully explained to you before you agree to take part.

Potential risks and benefits

Participating in a clinical trial can have potential benefits. You would receive close medical monitoring and access to a new experimental treatment that might help improve your condition, though this is not guaranteed as it's still being investigated. However, there are also potential risks; the new medication might have side effects that are not yet fully known, or it might not work for you. The medical procedures involved, like blood tests or scans, also carry very small risks. It's very important to remember that joining a study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your medical care.

Locations (26)

Barrow Neurological Institute
Phoenix, United States· Withdrawn
K2 Medical Research The Villages LLC
Lady Lake, United States· Recruiting
Charter Research, LLC
Orlando, United States· Recruiting
Headlands Horizons LLC
Orlando, United States· Not yet recruiting
Charter Research, LLC
The Villages, United States· Recruiting
Indiana University / IU Health
Indianapolis, United States· Recruiting
University of Kansas Medical Center Research Institute
Fairway, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
The Washington University
St Louis, United States· Recruiting
Flourish Research
Matthews, United States· Not yet recruiting
Neurology Clinical, P.C.
Cordova, United States· Recruiting
Vanderbilt University Medical Center
Nashville, United States· Recruiting

+14 more sites — see the official record for the full list.

Common questions

What is prodromal Alzheimer's disease?

It's a very early stage of Alzheimer's where people have mild memory or thinking problems noticeable by themselves or others, but they can still manage daily life.

What are amyloid plaques?

These are small clumps of protein that can build up in the brain and are believed to be an early sign of Alzheimer's disease.

What is a placebo?

A placebo is a substance that looks exactly like the study medication but doesn't contain any active drug. It helps researchers understand the true effects of the new medication.

Will I know if I'm getting the active drug or the placebo?

In this type of study, participants usually don't know whether they are receiving the active drug or the placebo. This helps ensure the study results are unbiased.

What is a 'study partner'?

A study partner is someone who knows you well, spends regular time with you (at least 10 hours a week), and can provide reliable information about your daily life and abilities for the study.

How to find out more

Olivier Sol, MD

clinicaltrials@acimmune.com +41 21 345 9121 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.