Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in 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.

Interventions

• EXV-802 · DRUG

  Specified dose twice daily

• Placebo · DRUG

  Specified dose twice daily

• EXV-801 · DRUG

  Specified dose twice daily

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion criteria:

1. 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.
2. A previously established diagnosis of AD dementia.
3. The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
5. 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:

1. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
2. The participant has symptoms of agitation that are not secondary to AD dementia
3. The participant has a history of uncontrolled seizures or a history of epilepsy.
4. The participant has a major medical illness or unstable medical condition

Sites (49)

• Esperanza Clinical, Murrieta, California · Recruiting
• Josephson Wallack Munshower Neurology PC, Indianapolis, Indiana · Recruiting
• Precise Research Centers, Flowood, Mississippi · Recruiting
• Galen Research LLC, Chesterfield, Missouri · Not yet recruiting
• Integrative Clinical Trials, Brooklyn, New York · Recruiting
• Manhattan Behavioral Medicine, New York, New York · Recruiting
• Insight Clinical Trials, Independence, Ohio · Recruiting
• Oregon Health & Science University, Portland, Oregon · Not yet recruiting
• The Memory Clinic, Bennington, Vermont · Recruiting
• Sunnybrook Health Sciences Centre, North York, Ontario · Not yet recruiting
• Baycrest Centre for Geriatric Care, North York, Ontario · Not yet recruiting
• Kawartha Centre, Peterborough, Ontario · Recruiting
• Ontario Shores Centre for Mental Health Sciences, Whitby, Ontario · Not yet recruiting
• Brain-Soultherapy s.r.o., Kladno, Central Bohemia · Recruiting
• NeuropsychiatrieHK, sro, Hradec Králové, Hradec Králové Region · Recruiting
• Psychiatrie-Ambulance s.r.o, Pilsen, Plzeň Region · Not yet recruiting
• FNUSA - St. Anne's University Hospital Brno, Brno, South Moravian · Not yet recruiting
• Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres, Böblingen, Baden-Wurttemberg · Recruiting
• Curiositas ad sanum Studien und Beratungs GmbH, Ebersberg, Bavaria · Recruiting
• TUM Klinikum rechts der Isar, München, Bavaria · Not yet recruiting
• Praxis Dr. med. Kirsten Hahn, Berlin, State of Berlin · Recruiting
• Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome, Lazio · Not yet recruiting
• Universita degli Studi di Roma ''La Sapienza" - Azienda Ospedaliera Sant'Andrea, Rome, Lazio · Not yet recruiting
• Azienda Ospedaliera Cardinale Giovanni Panico, Tricase, Lecce · Recruiting
• IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Lombardy · Recruiting
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus, Milan, Lombardy · Recruiting
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicily · Recruiting
• Centrum Medyczne HCP Sp. z o.o., Poznan, Greater Poland Voivodeship · Recruiting
• Krakowska Akademia Neurologii, Krakow, Lesser Poland Voivodeship · Recruiting
• NZOZ Wroclawskie Centrum Alzheimerowskie, Wroclaw, Lower Silesian Voivodeship · Recruiting
• FutureMeds Wroclaw, Wroclaw, Lower Silesian Voivodeship · Recruiting
• NZOZ Neuromed M. i M. Nastaj Spolka Partnerska, Lublin, Lublin Voivodeship · Not yet recruiting
• RCMed Oddzial Sochaczew, Sochaczew, Masovian Voivodeship · Recruiting
• ETG Neuroscience Sp. z o.o., Warsaw, Masovian Voivodeship · Recruiting
• Silmedic Sp. z o.o., Katowice, Silesian Voivodeship · Recruiting
• Clinhouse Sp. z o.o., Zabrze, Silesian Voivodeship · Recruiting
• Velocity Clinical Research, Staszów, Staszów, Świętokrzyskie Voivodeship · Recruiting
• MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o., Banská Bystrica, Banská Bystrica Region · Not yet recruiting
• Univerzitna nemocnica Bratislava, Bratislava, Bratislava Kraj · Not yet recruiting
• EPAMED s r.o., Košice, Košice Region · Not yet recruiting
• Crystal Comfort S.R.O., Vranov nad Topľou, Presov · Recruiting
• Medicinske Centrum Konzilium, s.r.o., Dubnica nad Váhom, Trenčín Region · Not yet recruiting
• Hospital Universitario Virgen de la Macarena, Seville, Andalusia · Recruiting
• Hospital Universitario Rio Hortega, Valladolid, Castille and León · Recruiting
• Hospital Virgen de la Concha, Zamora, Castille and León · Recruiting
• Hospital Universitari Germans Trias i Pujol, Barcelona, Catalonia · Not yet recruiting
• Hospital Clinico San Carlos, Madrid, Spain · Recruiting
• Scottish Brain Sciences, Edinburgh, Midlothian · Recruiting
• Scottish Brain Sciences, Aberdeen, North East Scotland · Recruiting