RecruitingPhase 2Phase 3NCT07284472
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants With Alzheimer's Disease Dementia
Sponsor
Exciva GmbH
Enrollment
300 participants
Start Date
Feb 2, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 55 YearsMax Age: 90 Years
Inclusion Criteria5
- 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.
Exclusion Criteria4
- 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
Interventions
DRUGEXV-802
Specified dose twice daily
DRUGPlacebo
Specified dose twice daily
DRUGEXV-801
Specified dose twice daily
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07284472