Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Recruiting · NCT07284472 · Interventional (participants receive a specific treatment) · Lead sponsor: Exciva GmbH
View the official record on ClinicalTrials.gov →Interventions studied
EXV-801EXV-802Placebo
What this trial is about
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.
Who can take part
Age range
55 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- A previously established diagnosis of AD dementia.
- The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
- The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
- Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day.
Exclusion criteria
- The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
- The participant has symptoms of agitation that are not secondary to AD dementia
- The participant has a history of uncontrolled seizures or a history of epilepsy.
- The participant has a major medical illness or unstable medical condition
Where it is running
49 locations listed across 8 US states.
- 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
- Hospital Clinico San Carlos - Madrid, Spain
- Hospital Universitario Virgen de la Macarena - Seville, Andalusia, Spain
- Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres - Böblingen, Baden-Wurttemberg, Germany
- MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o. - Banská Bystrica, Banská Bystrica Region, Slovakia
- Curiositas ad sanum Studien und Beratungs GmbH - Ebersberg, Bavaria, Germany
- TUM Klinikum rechts der Isar - München, Bavaria, Germany
- Univerzitna nemocnica Bratislava - Bratislava, Bratislava Kraj, Slovakia
- 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
- Brain-Soultherapy s.r.o. - Kladno, Central Bohemia, Czechia
- Centrum Medyczne HCP Sp. z o.o. - Poznan, Greater Poland Voivodeship, Poland
- NeuropsychiatrieHK, sro - Hradec Králové, Hradec Králové Region, Czechia
- EPAMED s r.o. - Košice, Košice Region, Slovakia
- 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
- Krakowska Akademia Neurologii - Krakow, Lesser Poland Voivodeship, Poland
- IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli - Brescia, Lombardy, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus - Milan, Lombardy, Italy
- 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
- Scottish Brain Sciences - Edinburgh, Midlothian, United Kingdom
- Scottish Brain Sciences - Aberdeen, North East Scotland, United Kingdom
- 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
- Psychiatrie-Ambulance s.r.o - Pilsen, Plzeň Region, Czechia
- Crystal Comfort S.R.O. - Vranov nad Topľou, Presov, Slovakia
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Palermo, Sicily, Italy
- Silmedic Sp. z o.o. - Katowice, Silesian Voivodeship, Poland
- Clinhouse Sp. z o.o. - Zabrze, Silesian Voivodeship, Poland
- FNUSA - St. Anne's University Hospital Brno - Brno, South Moravian, Czechia
- Praxis Dr. med. Kirsten Hahn - Berlin, State of Berlin, Germany
- Medicinske Centrum Konzilium, s.r.o. - Dubnica nad Váhom, Trenčín Region, Slovakia
- Velocity Clinical Research, Staszów - Staszów, Świętokrzyskie Voivodeship, Poland