Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia

To be considered for this study, you would need to be an adult between 55 and 90 years old. You should have a confirmed diagnosis of Alzheimer's disease dementia and be experiencing moderate to severe agitation that has lasted for at least two weeks. It's also important to have a caregiver who is able to help with the study requirements and spends at least two hours a day with you, four days a week.

There are a few reasons why someone might not be able to join. For example, if your memory problems are caused by a different disease, or if your agitation is not directly related to your Alzheimer's. You also wouldn't be able to take part if you have uncontrolled seizures, epilepsy, or another serious, unstable medical condition.

If you join this study, you would first go through a screening period, which lasts about four weeks, to check if you meet all the criteria. If you are eligible, you would then be randomly assigned to one of three groups: one group would receive EXV-802, another would receive EXV-801, and the third group would receive a placebo (a dummy treatment). Neither you, your caregiver, nor your study doctors would know which treatment you are getting. You would take the study medication as directed, and researchers would regularly check your health, agitation levels, and watch for any side effects. The study involves regular visits over a period of time, and your caregiver's involvement is also important for reporting your agitation symptoms. The total length of your participation would be explained to you in detail by the study team.