A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
This research study is investigating a new combination medicine, KarXT + KarX-EC, for people living with Alzheimer's disease. The main goals are to find out if this medicine can help improve problems with memory and thinking, which are common in Alzheimer's. Researchers also want to make sure the medicine is safe. Some people in the study will be given the new medicine, while others will receive a 'dummy' pill (called a placebo) that looks the same but contains no active ingredients. This helps scientists compare the effects. The study is currently in its third phase of testing, meaning it's being looked at in a larger group of people to gather more information.
At a glance
What is this study about?
This study is all about trying a new medicine called KarXT + KarX-EC for people who have Alzheimer's disease. As you might know, Alzheimer's can affect a person's thinking skills, memory, and ability to do daily tasks. The researchers want to see if this new medicine can help improve these thinking and memory problems, and also importantly, check if it's safe for people to take.
To make sure they get clear results, some people in the study will receive the new medicine, while others will get a 'placebo.' A placebo looks just like the real medicine but has no active ingredients. This is a common way to test new medicines, as it helps doctors tell if any changes people experience are due to the medicine itself or other factors.
This is a 'Phase 3' study, which means the medicine has already been studied in smaller groups. Now, it's being tested in a larger group of people to gather even more information about how well it works and its safety before it can be considered for wider use.
Key takeaways
- This study is testing a new medicine for memory and thinking in Alzheimer's.
- It aims to see if the new medicine, KarXT + KarX-EC, is effective and safe.
- Participants will receive either the new medicine or a placebo (dummy pill).
- A dedicated caregiver is required to support the participant.
- The study involves regular clinic visits and health checks.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, people generally need to be between 60 and 85 years old. They must have a diagnosis of Alzheimer's disease that is either mild or moderate. Doctors will use specific tests to confirm the diagnosis and how far along it is.
Another important point is that participants need to have a trusted caregiver who can spend at least 10 hours a week with them. This caregiver will be involved in the study – they'll attend appointments, help make sure medicines are taken correctly, and report on how the participant is doing. If someone is already taking other Alzheimer's medicines, like acetylcholinesterase inhibitors or memantine, they usually need to have been on a steady dose for at least 3 months and agree to continue that same dose throughout the study.
However, this study isn't suitable for everyone. People with serious medical conditions like liver or kidney problems, or uncontrolled blood pressure issues, wouldn't be able to join. Also, individuals with other major mental health conditions like severe depression or bipolar disorder, or a history of schizophrenia, would not be eligible. This is to ensure the safety of participants and to make sure the study results are as clear as possible.
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 60 and 85 years old?
- Do you have a mild to moderate diagnosis of Alzheimer's disease?
- Do you have a caregiver who can spend at least 10 hours a week with you and attend appointments?
- Are you able to commit to taking study medication and attending regular appointments?
- Do you have any serious liver, kidney, or heart problems?
- Do you have a primary mental health condition like severe depression or a history of schizophrenia?
What does participation involve?
Taking part in this study would involve regular visits to a clinic over a period of time. You would have different tests and assessments to check your memory and thinking skills. You would also have blood tests and other health checks to monitor your general health and see how your body is reacting to the medicine.
You would be given either the new study medicine or a placebo (a dummy pill, as described before). It's important to take the medicine exactly as instructed. Your caregiver would play a key role in helping with this and attending appointments with you.
The study would involve regular check-ups to see if the medicine is working and if there are any side effects. The total duration of your involvement in the study would be explained by the study team, and it would likely span several months.
Potential risks and benefits
Locations (106)
- Healthy Brain ClinicVerified postcodeLong Beach, United States· Recruiting
- Anderson Clinical ResearchVerified postcodeRedlands, United States· Recruiting
- Mountain Neurological Research CenterVerified postcodeBasalt, United States· Recruiting
- Georgetown University Medical CenterVerified postcodeWashington D.C., United States· Recruiting
- JEM Research InstituteVerified postcodeAtlantis, United States· Recruiting
- VIN-Julie SchwartzbardVerified postcodeAventura, United States· Recruiting
- Merritt Island Medical Research, LLCVerified postcodeMerritt Island, United States· Recruiting
- Renstar Medical ResearchVerified postcodeOcala, United States· Recruiting
- Alzheimer's Research and Treatment CenterVerified postcodeStuart, United States· Recruiting
- Charter Research - Lady LakeVerified postcodeThe Villages, United States· Recruiting
- Local Institution - 0016Verified postcodeColumbus, United States· Withdrawn
- Center for Advanced Research & EducationVerified postcodeGainesville, United States· Recruiting
Common questions
What is KarXT + KarX-EC?
It's a new combination medicine being tested to see if it can help with memory and thinking problems in people with Alzheimer's disease.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but doesn't contain any active ingredients. It's used to compare against the real medicine.
Who can be a caregiver in this study?
A caregiver needs to be someone trusted who can spend at least 10 hours a week with you, attend appointments, and help with medication.
Is this medicine approved for use yet?
No, this is a research study (Phase 3), meaning the medicine is still being tested and is not yet available to the public.
Will I know if I'm getting the real medicine or the placebo?
No, during the study, neither you, your caregiver, nor the study doctors will know who is receiving the active medicine and who is receiving the placebo. This is to keep the study fair.
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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