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
Exciva GmbH
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.
Description
This is a Phase 2/3 multicenter, double-blind, placebo-controlled, three-arm, multicenter study evaluating the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia. The diagnosis of agitation will be based on the consensus definition for agitation in patients with cognitive disorders developed by te International Psychogeriatric Association (IPA) Agitation Definition Work Group as well as neuroimaging performed after onset of dementia symptoms and a Core 1 AD biomarker. The study will be conducted at up to 60 centers in the US,…
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. 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. 2. A previously established diagnosis of AD dementia. 3. The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization 4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation. 5. Caregiver who is able and willing to comply with all required study procedures and who…
Interventions
- DrugEXV-802
Specified dose twice daily
- DrugPlacebo
Specified dose twice daily
- DrugEXV-801
Specified dose twice daily
Locations (14)
- Esperanza ClinicalMurrieta, California
- Josephson Wallack Munshower Neurology PCIndianapolis, Indiana
- Precise Research CentersFlowood, Mississippi
- Integrative Clinical TrialsBrooklyn, New York
- Manhattan Behavioral MedicineNew York, New York
- Insight Clinical TrialsIndependence, Ohio