BioXcel's BXCL501 Phase 3 Trial for Alzheimer's-Related Agitation

BioXcel Therapeutics, a company that uses AI to create new medicines, is planning a new study on a drug called BXCL501. This drug is a special type of dexmedetomidine that can dissolve in your mouth and they think it can help with a problem called agitation in people who have Alzheimer's disease. Agitation can make people with Alzheimer's feel restless and upset.

The study, named TRANQUILITY In-Care, will be very careful and thorough. It will compare BXCL501 with a dummy pill that has no medicine in it to see which is better. The plan is to give this drug to around 150 people who are 55 years old or older and have different levels of Alzheimer's disease. These people will live in places where they get special care because of their condition.

In the study, the people will take the drug or the dummy pill when they start to feel agitated. The main goal of the study is to see if the drug can make the agitation better after two hours. They will also check other things, like how the person feels overall.

BioXcel Therapeutics has already talked to the FDA, which is a group that makes sure medicines are safe, about this study. They are excited because there is no other medicine that is approved to help with this kind of agitation in the U.S. right now.

The company also makes a medicine called IGALMI, which is used for agitation in people with mental illnesses like schizophrenia and bipolar disorder. But IGALMI has not been tested on children and its safety for longer than a day is not known.

IGALMI can cause some problems like making your blood pressure drop, making your heart beat slower, and making you feel sleepy. If you use it, you should tell your doctor about any health problems you have and any other medicines you are taking.

The company is hoping that this new study will help them learn more about BXCL501 and how it can help people with Alzheimer's disease. They will also be looking at how safe it is to use for a long time.