A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
This research trial, called ADEPT-1, is exploring a new medicine named KarXT for individuals living with Alzheimer's disease who also experience psychosis. Psychosis can cause unusual thoughts or perceptions. The study aims to see if KarXT can help prevent these symptoms from coming back and to ensure it's safe. Participants will be randomly given either KarXT or a placebo (a dummy pill with no medicine) and carefully monitored for about 38 weeks. It's a 'double-blind' study, meaning neither the participants nor their doctors will know who is receiving the actual medicine. This helps ensure fair and accurate results. The main goal is to understand if KarXT is effective in preventing relapses and to assess any side effects.
At a glance
What is this study about?
You might be reading this because you, or someone you care for, is living with Alzheimer's disease and also experiencing psychosis. Psychosis can involve difficulty telling what's real, such as seeing or hearing things that aren't there, or holding unusual beliefs. These symptoms can be very distressing and challenging for everyone involved. Researchers are always looking for better ways to help people manage these difficulties.
This study, called ADEPT-1, is a clinical trial designed to investigate a new medication named KarXT. The main purpose is to see if KarXT can help prevent psychosis symptoms from returning in people with Alzheimer's disease. They also want to understand if the medication is safe to use and how well people tolerate it compared to a placebo, which is a pill that looks the same but contains no active medicine. Finding effective and safe treatments is crucial for improving the quality of life for individuals and their families.
The trial is in 'Phase 3,' which means it's a large study, usually one of the last steps before a medicine might be considered for wider use. It will involve many participants from different locations, and everyone will be carefully looked after by a team of medical professionals. Your participation could help researchers learn valuable information that might benefit many others in the future.
Key takeaways
- This study is testing a new drug (KarXT) for psychosis in Alzheimer's.
- It compares KarXT to a dummy pill (placebo) over 38 weeks.
- The main goals are to prevent symptoms from returning and check safety.
- Participants need a caregiver who spends at least 10 hours a week with them.
- You'll have regular medical check-ups throughout the study.
- Your participation could help future treatments for Alzheimer's and psychosis.
Who may be eligible?
This study is looking for volunteers who are between 55 and 90 years old. You would need to have a diagnosis of possible or probable Alzheimer's disease and have experienced symptoms of psychosis for at least two months prior to joining.
It's important that you or your legal representative understand what the study involves and are able to give consent to take part. You also need to have a caregiver or study partner who can reliably help with your appointments and provide information about your well-being. This person should spend at least 10 hours a week with you and be willing to participate throughout the study.
To ensure your health and safety, you'll need to have had a brain scan (like an MRI or CT) within the last five years, or have one done during the screening process, to rule out other medical conditions that might be causing your memory problems.
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 between 55 and 90 years old?
- Do you have a diagnosis of possible or probable Alzheimer's disease?
- Have you experienced psychosis symptoms for at least 2 months?
- Do you have a caregiver who can attend appointments and help with medication?
- Have you had a brain scan (MRI or CT) in the past 5 years?
- Can you or your legal representative understand and agree to participate?
What does participation involve?
If you decide to take part, you'll be assigned by chance to either receive the study drug KarXT or a placebo (a dummy pill). Neither you, your caregiver, nor your study doctors will know which one you are taking – this is called a 'double-blind' approach and helps ensure the results are fair. The study will last for approximately 38 weeks, which is about 9 months.
Throughout this time, you will have regular visits to the clinic. At these visits, doctors and nurses will monitor your health, ask about your symptoms, and may perform assessments to check your memory, behaviour, and overall well-being. Your caregiver will also be asked to provide information about your status and help ensure you take your medication as instructed. You'll need to live at the same location for the duration of the study, and be able to move around, either on your own or with help from a walking aid.
Potential risks and benefits
Locations (116)
- Local Institution - 1029Verified postcodeHomewood, United States· Active not recruiting
- Local Institution - 1044Verified postcodePhoenix, United States· Completed
- Local Institution - 1033Verified postcodeEncino, United States· Completed
- Local Institution - 1031Verified postcodeIrvine, United States· Withdrawn
- ATP Clinical Research-302 W La Veta AveVerified postcodeOrange, United States· Recruiting
- Local Institution - 1043Verified postcodePasadena, United States· Completed
- Local Institution - 1047Verified postcodeSan Marcos, United States· Completed
- Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDSVerified postcodeWalnut Creek, United States· Recruiting
- Local Institution - 1014Verified postcodeColorado Springs, United States· Completed
- Local Institution - 1013Verified postcodeStamford, United States· Completed
- Local Institution - 1011Verified postcodeBoca Raton, United States· Completed
- Envision Trials LLCVerified postcodeBonita Springs, United States· Recruiting
Common questions
What is psychosis associated with Alzheimer's disease?
This refers to unusual thoughts, beliefs, or perceptions, like seeing or hearing things that aren't there, experienced by some people who have Alzheimer's disease.
What is KarXT?
KarXT is a new experimental medication being tested in this study to see if it can help manage psychosis symptoms in people with Alzheimer's disease.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the study medication but contains no active medicine. It helps researchers fairly compare how well the actual drug works.
How long will the study last?
The study will last for about 38 weeks, which is roughly 9 months.
Do I have to pay to join the study?
No, you should not have to pay to participate in a clinical trial. All study-related medication and assessments are usually provided at no cost, but it's always good to confirm this with the study team.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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