Evaluating Safety and Effectiveness of EXV-802 and EXV-801 for Treating Agitation in Adults with Alzheimers Disease Dementia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two drugs, EXV-802 and EXV-801, for treating agitation in people with Alzheimers Disease dementia. This Phase 23 clinical trial is multicenter, double-blind, placebo-controlled, and includes about 300 participants diagnosed with Alzheimers-related agitation based on established criteria and biomarkers. The trial is sponsored by Exciva GmbH and conducted in the US, Canada, and Europe. Participants will be randomly assigned to one of three groups receiving EXV-802 capsules, EXV-801 capsules, or placebo capsules, each taken twice daily for 6 weeks. Before treatment, a screening period of about 4 weeks will ensure participants meet all criteria. The trial compares these treatments to assess potential benefits and safety. During the study, participants will be monitored regularly, including assessments of agitation severity using the Cohen-Mansfield Agitation Inventory and Clinical Global Impression of Severity scores at baseline and after 6 weeks. Caregivers will play a key role by being in contact with participants for at least two hours on four separate days weekly. Safety and treatment effects will be followed throughout the trial until its completion in 2029.

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