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Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-02-02
Completion Date
2029-02
Last Updated
2026-06-05
Healthy Volunteers
No
Interventions
EXV-802
Specified dose twice daily
Placebo
Specified dose twice daily
EXV-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