RecruitingPHASE3INTERVENTIONAL

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

This study, called ADEPT-3, is an ongoing look at a new medicine called KarXT. It's for people who experience symptoms like seeing or hearing things that aren't there, or having unusual beliefs, because of Alzheimer's disease. This is a "Phase 3" study, which means the medicine has already been through earlier stages of testing. Participants have already been involved in one of three other studies with KarXT. This new part of the study will last for 52 weeks (about a year) and aims to understand how safe KarXT is over a longer period and if people can tolerate taking it. It's an "open-label" study, meaning everyone involved, including the participants and their doctors, knows they are receiving the KarXT medicine.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Enrolment target

800

Start

11 Jul 2023

Estimated completion

07 Sep 2027

Psychosis Associated With Alzheimer's Disease

What is this study about?

This study, called ADEPT-3, is looking into a new medicine called KarXT for people who have symptoms like seeing or hearing things that aren't there, or having unusual beliefs, as part of their Alzheimer's disease. These symptoms can be very upsetting for both the person experiencing them and their carers.

The main goal of this study is to understand the long-term safety of KarXT and how well people tolerate it. This means the researchers want to find out if there are any side effects over a longer period and if people can continue taking the medicine comfortably. This study is an extension of previous studies, so everyone taking part has already had some experience with KarXT.

The study will last for about a year, and it's "open-label," which means everyone involved knows the participants are receiving the KarXT medicine. By gathering more information over time, researchers hope to get a clear picture of KarXT's safety when used for a longer duration in people with Alzheimer's-related changes in their thoughts and feelings.

Key takeaways

This study is for people who have already taken part in a previous KarXT study.
It's looking at the long-term safety and how well people tolerate KarXT for symptoms linked to Alzheimer's disease.
The study will last for about one year, with regular check-ups.
You'll know you're getting the KarXT medicine (it's 'open-label').
Having a caregiver involved is important for taking part.
Your health and safety will be carefully monitored throughout the study.

Who may be eligible?

To be able to join this study, you must have already finished one of three previous studies (CN012-0026, CN012-0027, or CN012-0056) about the same medicine. When you first joined one of those earlier studies, you needed to be between 55 and 90 years old. You should also be able to understand what the study involves and agree to take part, or have a family member or carer who can make decisions for you and provide their consent if you're unable to.

It's also important to have a caregiver (someone who helps you, spending about 10 hours a week with you) who can support you during the study. If your health condition is severe or could make it unsafe for you to take part, or if you're already in another study testing a new medicine or device, you would not be able to join this particular study. The study doctors will carefully check your health at the end of the previous study to make sure it's safe for you to continue.

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.

Did I finish one of the earlier KarXT studies (CN012-0026, CN012-0027, or CN012-0056)?
Was I between 55 and 90 years old when I started that first study?
Do I have a caregiver who spends about 10 hours a week with me?
Am I generally healthy enough, in the doctor's opinion, to take part safely?
Am I not currently involved in another study testing a new medicine or device?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will continue to receive the KarXT medicine. The study will last for about 52 weeks, which is roughly one year. During this time, you'll have regular check-ups with the study team. These check-ups will involve things like physical examinations, blood tests, and vital signs (like blood pressure and heart rate) to monitor your health and how you're responding to the medicine.

You'll also be asked questions about how you are feeling and any effects you might be experiencing. The specific number of visits and tests will be explained in detail by the study team, but the overall aim is to keep a close eye on your safety and how well you are tolerating the medicine over this longer period.

Potential risks and benefits

Taking part in this study may offer the benefit of continuing to receive a medicine that could help with symptoms related to Alzheimer's disease, and you will contribute to important research that could help others in the future. However, as with any medicine, there is a chance of side effects, even if you have not experienced them before or if their nature changes over time. The study team will monitor you closely for any new or worsening health issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (426)

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

Local Institution - 1029
Verified postcode
Homewood, United States· Withdrawn
Local Institution - 1-13H98LK9
Verified postcode
Chandler, United States· Withdrawn
Local Institution - 1227
Verified postcode
Chandler, United States· Withdrawn
Local Institution - 1116
Verified postcode
Chandler, United States· Withdrawn
Local Institution - 1247
Verified postcode
Gilbert, United States· Not yet recruiting
Local Institution - 1217
Verified postcode
Phoenix, United States· Not yet recruiting
Local Institution - 1044
Verified postcode
Phoenix, United States· Withdrawn
Local Institution - 1220
Verified postcode
Scottsdale, United States· Withdrawn
Advanced Research Center, Inc.
Verified postcode
Anaheim, United States· Recruiting
Local Institution - 1-141NO1DG
Verified postcode
Chino, United States· Not yet recruiting
Local Institution - 1001
Verified postcode
Costa Mesa, United States· Withdrawn
Local Institution - 1151
Verified postcode
Encino, United States· Withdrawn

Common questions

What is KarXT?

KarXT is a new medicine being studied for people who experience changes in their thoughts and feelings due to Alzheimer's disease.

How long will this study last?

This study will last for about 52 weeks, which is approximately one year.

Will I know if I'm getting the medicine?

Yes, this is an "open-label" study, meaning you and the study team will know that you are receiving the KarXT medicine.

What is a 'caregiver' for this study?

A caregiver is someone who helps you and spends about 10 hours a week with you. Their support is important for this study.

What does 'long-term safety' mean?

It means the researchers are looking to see if the medicine is safe to take over a longer period, beyond the initial studies, and to check for any delayed side effects.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.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.