Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age55-90
SponsorExciva GmbH
About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- EXV-802
- Placebo
- EXV-801
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov