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

Agitation Associated With Alzheimer's Disease Dementia

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.

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Interventions

DRUGEXV-802

Specified dose twice daily

DRUGPlacebo

Specified dose twice daily

DRUGEXV-801

Specified dose twice daily

Locations(49)

Esperanza Clinical

Murrieta, California, United States

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, United States

Precise Research Centers

Flowood, Mississippi, United States

Galen Research LLC

Chesterfield, Missouri, 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

Brain-Soultherapy s.r.o.

Kladno, Central Bohemia, Czechia

NeuropsychiatrieHK, sro

Hradec Králové, Hradec Králové Region, Czechia

Psychiatrie-Ambulance s.r.o

Pilsen, Plzeň Region, Czechia

FNUSA - St. Anne's University Hospital Brno

Brno, South Moravian, Czechia

Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres

Böblingen, Baden-Wurttemberg, Germany

Curiositas ad sanum Studien und Beratungs GmbH

Ebersberg, Bavaria, Germany

TUM Klinikum rechts der Isar

München, Bavaria, Germany

Praxis Dr. med. Kirsten Hahn

Berlin, State of Berlin, Germany

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Lazio, Italy

Universita degli Studi di Roma ''La Sapienza" - Azienda Ospedaliera Sant'Andrea

Rome, Lazio, Italy

Azienda Ospedaliera Cardinale Giovanni Panico

Tricase, Lecce, Italy

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, Lombardy, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus

Milan, Lombardy, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, Italy

Centrum Medyczne HCP Sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland

Krakowska Akademia Neurologii

Krakow, Lesser Poland Voivodeship, Poland

NZOZ Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, Poland

FutureMeds Wroclaw

Wroclaw, Lower Silesian Voivodeship, Poland

NZOZ Neuromed M. i M. Nastaj Spolka Partnerska

Lublin, Lublin Voivodeship, Poland

RCMed Oddzial Sochaczew

Sochaczew, Masovian Voivodeship, Poland

ETG Neuroscience Sp. z o.o.

Warsaw, Masovian Voivodeship, Poland

Silmedic Sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Clinhouse Sp. z o.o.

Zabrze, Silesian Voivodeship, Poland

Velocity Clinical Research, Staszów

Staszów, Świętokrzyskie Voivodeship, Poland

MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.

Banská Bystrica, Banská Bystrica Region, Slovakia

Univerzitna nemocnica Bratislava

Bratislava, Bratislava Kraj, Slovakia

EPAMED s r.o.

Košice, Košice Region, Slovakia

Crystal Comfort S.R.O.

Vranov nad Topľou, Presov, Slovakia

Medicinske Centrum Konzilium, s.r.o.

Dubnica nad Váhom, Trenčín Region, Slovakia

Hospital Victoria Eugenia Cruz Roja Sevilla

Seville, Andalusia, Spain

Hospital Universitario Rio Hortega

Valladolid, Castille and León, Spain

Hospital Virgen de la Concha

Zamora, Castille and León, Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, Catalonia, Spain

Hospital Clinico San Carlos

Madrid, Spain

Scottish Brain Sciences

Edinburgh, Midlothian, United Kingdom

Scottish Brain Sciences

Aberdeen, North East Scotland, United Kingdom

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NCT07284472

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