NCT07284472 · Phase 2 · RECRUITING
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
This trial is testing two experimental drugs, EXV-802 and EXV-801, against a placebo in people who already have Alzheimer's dementia and moderate to severe agitation. It looks at safety and whether agitation improves. It is a Phase 2 trial, meaning early testing of whether it works and is safe, not yet proven or approved.
You may qualify if
- The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair.
- A previously established diagnosis of AD dementia.
- The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
- The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
- Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day.
You're excluded if
- The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
- The participant has symptoms of agitation that are not secondary to AD dementia
- The participant has a history of uncontrolled seizures or a history of epilepsy.
- The participant has a major medical illness or unstable medical condition
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-14