A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
This research study is looking into a new medication called KarXT. It's for individuals aged between 55 and 90 who have Alzheimer's disease and are experiencing symptoms of psychosis, such as hallucinations (seeing or hearing things others don't) or delusions (strong beliefs that aren't real). The main goal is to find out how well KarXT works compared to a placebo (a dummy medicine) in reducing these particular symptoms. The study will also carefully check for any side effects to make sure the medicine is safe. Participants will be randomly assigned to receive either KarXT or the placebo, and neither they nor their doctors will know which treatment they are getting. This helps us get clearer results about the medicine's true effects. The study focuses on people with mild to severe Alzheimer's and moderate to severe psychosis related to their condition.
At a glance
What is this study about?
This research study is designed to explore a new potential treatment called KarXT for certain people living with Alzheimer's disease. We know that Alzheimer's can sometimes cause additional challenges, such as psychosis, which might include seeing or hearing things that aren't there (hallucinations) or having very strong, false beliefs (delusions). The purpose of this study, called ADEPT-2, is to see if KarXT can help reduce these symptoms in a safe way.
Participants in this study will be aged 55 to 90 and will have already been diagnosed with Alzheimer's disease. They will also be experiencing moderate to severe symptoms of psychosis linked to their Alzheimer's. The study compares KarXT to a 'placebo' – which looks exactly like the study medicine but contains no active ingredient. This is a common way to test new medicines and helps us understand if any improvements are truly due to KarXT or other factors.
Neither you nor your study doctor will know whether you are receiving KarXT or the placebo, which helps ensure the study results are as unbiased as possible. The main thing the researchers want to find out is how effective KarXT is at lessening hallucinations and delusions. They will also be looking very carefully at any side effects to make sure the medication is safe for people to use.
Key takeaways
- This study is for people aged 55-90 with Alzheimer's and specific psychosis symptoms.
- It tests a new medicine, KarXT, against a dummy medicine (placebo).
- The main goal is to see if KarXT reduces hallucinations and delusions.
- A study partner is needed who knows you well.
- Your health and safety will be carefully monitored throughout the study.
- Participation is voluntary, and you can leave at any time.
Who may be eligible?
To join this study, you would generally need to be a man or a woman between 55 and 90 years old. You should have a diagnosis of Alzheimer's disease, and also be experiencing moderate to severe symptoms of psychosis, such as hallucinations or delusions. It's important that these symptoms have been present for at least two months.
The study also requires you to have had a brain scan (like an MRI or CT scan) within the last five years, or be willing to have one, to make sure your symptoms aren't caused by something other than Alzheimer's. You'll need to be living in the same home or care facility for at least six weeks before starting. Plus, you'll need a study partner – someone who knows you well, sees you almost every day (at least 10 hours a week), and can help with information about your health.
There are also reasons why people might not be able to join. For example, if your psychosis is thought to be mainly due to something other than Alzheimer's, or if you have a history of certain mental health conditions like bipolar disorder or schizophrenia. People with serious medical problems affecting their lungs, liver, kidneys, or blood might also not be eligible.
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 Alzheimer's disease?
- Are you experiencing hallucinations or delusions that have lasted at least two months?
- Do you have a family member or friend who sees you often and could be your study partner?
- Have you had a brain scan (MRI or CT) in the last 5 years, or would you be willing to have one?
What does participation involve?
If you decide to take part, you'll be randomly assigned to either receive the study medicine (KarXT) or a dummy medicine (placebo). No one will know which one you're getting. You would attend regular appointments at the study clinic where you'll have various health checks, assessments of your memory and thinking, and evaluations of your psychosis symptoms. These assessments might include talking to you and your study partner, and filling out questionnaires. Medication will be provided during your clinic visits. During the study, your health will be closely monitored, and you'll have follow-up appointments to track any changes or side effects. The total duration of your participation in this study, including all visits and follow-up, will be explained by the study team.
Potential risks and benefits
Locations (154)
- Local Institution - 1116Verified postcodeChandler, United States· Active not recruiting
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- Local Institution - 1104Verified postcodeAnaheim, United States· Active not recruiting
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- Local Institution - 1142Verified postcodeLancaster, United States· Active not recruiting
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- Local Institution - 1160Verified postcodeApopka, United States· Withdrawn
- Local Institution - 1156Verified postcodeClermont, United States· Active not recruiting
- Local Institution - 1138Verified postcodeCutler Bay, United States· Active not recruiting
Common questions
What is psychosis in Alzheimer's disease?
Psychosis in Alzheimer's can mean experiencing hallucinations (seeing or hearing things that aren't there) or delusions (having strong, false beliefs, like thinking someone is trying to harm you).
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving KarXT or the placebo. This is to ensure the study results are as fair and accurate as possible.
Who is a 'study partner'?
A study partner is someone who knows you well, sees you regularly (at least 10 hours a week), and can help the study team understand your symptoms and how you're feeling.
Can I leave the study if I change my mind?
Yes, absolutely. Taking part is voluntary, and you can withdraw from the study at any time without needing to give a reason, and it won't affect your usual medical care.
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?
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