CN012-0025: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)
This research study, called ADAGIO-3, is looking at a new treatment called KarXT, sometimes combined with KarX-EC, for individuals with Alzheimer's disease who experience agitation. Agitation can be a challenging symptom, and this study aims to see how safe and well-tolerated the treatment is over a longer period. It's an 'open-label extension' study, meaning everyone involved knows what treatment they are receiving, and it follows on from earlier research. The main focus is to carefully track any side effects that might happen while people are taking the medication. Researchers will also monitor other important health changes like blood pressure, weight, and mental sharpness, to get a complete picture of the treatment's impact.
At a glance
What is this study about?
This study, known as ADAGIO-3, is for people living with Alzheimer's disease who experience agitation. Agitation can manifest as restlessness, aggression, or distress, and it can be very challenging for both the person with Alzheimer's and their caregivers. This research is testing a new medication called KarXT, sometimes with an additional component called KarX-EC, to see how it affects these symptoms.
This particular study is a 'Phase 3' trial, which means it's one of the final stages of testing a new medicine before it might become widely available. It's an 'extension study,' too, which means it follows people who have already been part of earlier trials of this treatment. The main goal here is to carefully watch what happens over a longer period. We already know some things about this medication from previous studies, but understanding its long-term effects and safety is crucial.
The most important thing researchers are looking for in this study is any side effects, big or small, that might occur while people are taking the medication. They will also be checking other aspects of health, such as changes in weight, blood pressure, heart rate, and any changes in how well people are thinking. This detailed monitoring helps ensure the treatment is as safe as possible for long-term use.
Key takeaways
- This study evaluates the long-term safety of a new drug, KarXT, for agitation in Alzheimer's.
- It's an extension of previous studies, focusing on sustained safety and how well people tolerate the treatment.
- Researchers will closely monitor for any side effects and other health changes.
- Participants must have Alzheimer's disease and agitation, and be at least 18 years old.
- Taking part offers access to a new treatment and helps future patients.
- You can leave the study at any time without affecting your normal medical care.
Who may be eligible?
To join this study, people must have Alzheimer's disease and experience agitation. The study is open to both men and women.
Participants must be at least 18 years old. There is no upper age limit, meaning older adults are welcome to participate if they meet all other study requirements.
- Do you (or the person you care for) have Alzheimer's disease?
- Do you (or the person you care for) experience agitation as part of Alzheimer's?
- Are you (or the person you care for) aged 18 years or older?
- Are you able to attend regular study visits as required?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the study medication, KarXT (and possibly KarX-EC). You will have regular visits with the study doctors and nurses. During these visits, the medical team will perform various assessments, including checking for any side effects, taking blood samples, measuring your blood pressure and heart rate, and assessing your weight. There will also be evaluations to understand how your thinking abilities are doing and to check for any movements that are not intentional. The study involves ongoing follow-up to monitor your health and the effects of the medication over a longer period. The total duration of your participation will be explained by the study team.
Potential risks and benefits
Locations (11)
- —Croatia
- —Romania
- —France
- —Spain
- —Italy
- —Greece
- —Czechia
- —Bulgaria
- —Poland
- —Portugal
- —Hungary
Common questions
What is agitation in Alzheimer's disease?
Agitation refers to symptoms like restlessness, pacing, shouting, or sometimes aggressive behaviours that can occur in people with Alzheimer's disease.
What does 'open-label' mean?
It means that both you, your doctor, and the study team will know which study medication you are receiving, unlike some studies where participants don't know.
What are 'side effects'?
Side effects are any unwanted or unexpected effects that happen while taking a medication. They can be mild or more serious.
Will I have to pay to be in the study?
Clinical trials generally cover the cost of study-related medication and visits. You will not have to pay for the experimental treatment or the study-specific tests.
How long will the study last for me?
The total length of your participation will be discussed in detail by the study team, as it can vary for different studies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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