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

Plain Language Summary

Simplified for easier understanding

This study is testing two new drugs, EXV-802 and EXV-801, to see if they are safe and effective at reducing agitation in people with Alzheimer's disease dementia — a common and distressing symptom where patients become physically or verbally aggressive, restless, or extremely unsettled. **You may be eligible if...** - You are between 55 and 90 years old - You have a diagnosis of Alzheimer's disease dementia - You have significant agitation that has been present for at least 2 weeks before the study - Your agitation meets the formal International Psychogeriatric Association definition - You can move around on your own, with a walker, or in a wheelchair - You have a caregiver who can be with you at least 2 hours a day on 4 days per week and is willing to help with study requirements **You may NOT be eligible if...** - Your primary diagnosis is a different type of dementia (not Alzheimer's) - Your agitation is mild and does not meet the clinical threshold - You do not have a reliable caregiver available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEXV-802

Specified dose twice daily

DRUGPlacebo

Specified dose twice daily

DRUGEXV-801

Specified dose twice daily


Locations(14)

Esperanza Clinical

Murrieta, California, United States

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, United States

Precise Research Centers

Flowood, Mississippi, United States

Integrative Clinical Trials

Brooklyn, New York, United States

Manhattan Behavioral Medicine

New York, New York, United States

Insight Clinical Trials

Independence, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

The Memory Clinic

Bennington, Vermont, United States

Sunnybrook Health Sciences Centre

North York, Ontario, Canada

Baycrest Centre for Geriatric Care

North York, Ontario, Canada

Kawartha Centre

Peterborough, Ontario, Canada

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, Canada

Scottish Brain Sciences

Edinburgh, Midlothian, United Kingdom

Scottish Brain Sciences

Aberdeen, North East Scotland, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07284472


Related Trials