RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

This research study is called ADAGIO-3 and focuses on a new treatment for agitation, which is common in people with Alzheimer's disease. The study is testing two experimental capsules, KarXT and KarX-EC, to see how safe and effective they are over a longer period. Participants in this study will have previously taken part in other specific studies (CN012-0023 or CN012-0024) looking at the same medication. The main goals are to understand if this combined treatment can help reduce agitation and if it has any side effects when used for an extended time. This information helps doctors learn more about managing agitation in Alzheimer's patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

600

Start

02 Dec 2025

Estimated completion

20 Jul 2029

Alzheimer Disease Agitation

What is this study about?

This study, called ADAGIO-3, is focused on helping people with Alzheimer's disease who experience agitation. Agitation can mean feeling restless, anxious, or distressed, and it's a common challenge for both patients and their families. Researchers are looking into whether a new combination of experimental medications, given as special capsules known as KarXT and KarX-EC, can help manage these symptoms over a long period. Think of it as a long-term look at how these new medicines work.

The main purpose of this study is to check two important things: first, if the medication continues to be effective at reducing agitation over an extended time, and second, if it is safe to use long-term. This study is specifically for people who have already taken part in two earlier related studies (called CN012-0023 or CN012-0024) where they also received this experimental treatment. By continuing to follow these participants, doctors can gather valuable information on the long-term effects of the medicine.

Learning more about safe and effective long-term treatments for agitation in Alzheimer's disease is very important. It can lead to better care and improved quality of life for many people living with this condition. The information gathered from studies like ADAGIO-3 helps the medical community understand new medicines better before they might become widely available.

Key takeaways

This study is testing a new medication (KarXT + KarX-EC) for agitation in Alzheimer's disease.
It's a long-term study focusing on safety and how well the treatment works over time.
Only people who previously participated in specific related studies can join.
Participants will take capsules and attend regular clinic visits for health checks.
The study aims to improve understanding of managing agitation in Alzheimer's.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must have already taken part in one of two previous studies, either CN012-0023 or CN012-0024, and completed it according to the study rules. You also need to have a caregiver who spends at least 10 hours a week with you.

There are also some health conditions that would mean you couldn't join. For example, if you have serious untreated or unstable heart conditions, specific lung problems, kidney issues, blood disorders, stomach problems, hormone imbalances, immune system problems, skin conditions, nervous system conditions, or cancer. The study doctors need to make sure that taking part won't be risky for your health or affect the study results.

The study is open to both men and women, and participants must be between 55 and 90 years old.

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.

Have I taken part in studies CN012-0023 or CN012-0024 and completed them?
Do I have a caregiver who spends at least 10 hours a week with me?
Am I between 55 and 90 years old?
Do I have any serious untreated heart, lung, kidney, or other major health problems?
Am I generally in good health apart from my Alzheimer's disease?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking either the KarXT or KarX-EC capsules, just as you did in the previous study. You'll have regular visits to the clinic for check-ups. During these visits, the study team will: perform physical exams, take blood and urine samples, measure your vital signs (like blood pressure and heart rate), and ask you questions about your memory, mood, and how you are feeling generally. Your caregiver will also be asked to provide information about your agitation symptoms and daily life.

The team will check how well the medication is working and watch for any side effects. The total duration of your participation will depend on the study's plan for long-term follow-up, which will be explained in detail by the study staff. You will be given appointments for these visits and told what to expect each time.

Potential risks and benefits

Participating in this study might offer a potential benefit if the experimental medication helps to manage your agitation symptoms over the long term. However, it's important to remember that this is an experimental drug, and there's no guarantee it will work for everyone, or that it will be better than existing treatments. Like all medications, it could have side effects, which the study team will monitor closely. You will be fully informed of any known or potential risks before you decide to join. It is your right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (255)

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

Local Institution - 2609
Verified postcode
Chandler, United States· Not yet recruiting
Imaging Endpoints
Verified postcode
Scottsdale, United States· Recruiting
Local Institution - 1657
Verified postcode
Anaheim, United States· Not yet recruiting
Local Institution - 2620
Verified postcode
Canoga Park, United States· Not yet recruiting
Local Institution - 1637
Verified postcode
La Jolla, United States· Not yet recruiting
Local Institution - 2625
Verified postcode
Long Beach, United States· Not yet recruiting
Local Institution - 2607
Verified postcode
Long Beach, United States· Not yet recruiting
Local Institution - 2642
Verified postcode
Long Beach, United States· Not yet recruiting
Local Institution - 2613
Verified postcode
Pasadena, United States· Not yet recruiting
Local Institution - 1662
Verified postcode
Pomona, United States· Not yet recruiting
Local Institution - 1639
Verified postcode
Torrance, United States· Not yet recruiting
Local Institution - 1651
Verified postcode
Walnut Creek, United States· Not yet recruiting

Common questions

What is agitation in Alzheimer's disease?

Agitation refers to feelings of restlessness, anxiety, or distress, which are common in people with Alzheimer's. It can mean pacing, shouting, or general unease.

What are KarXT and KarX-EC?

These are the names of the experimental medications being tested. They come in capsule form and are being studied for their potential to help with agitation in Alzheimer's.

Why is this study only for people from previous studies?

This study is a follow-on from earlier trials. It helps researchers gather long-term safety and effectiveness information on the same experimental drug from participants who have already started using it.

Will I know if I am getting the active drug?

In some studies, participants might not know if they are receiving the active drug or a placebo, but for this specific long-term study, it's aimed at people who've already received the drug in earlier studies, so you would likely be continuing the experimental treatment.

What is a 'Phase 3' trial?

A Phase 3 trial means the study drug has already shown promise in earlier, smaller studies. This phase involves a larger group of people to confirm its effectiveness, monitor side effects, and compare it to existing treatments or a placebo.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

clinical.trials@bms.com 855-907-3286 Official trial record

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