Clinical Trials in Italy / NCT07284472
Recruiting
Phase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
NCT07284472 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Agitation Associated With Alzheimer's Disease Dementia
Investigational drug(s) / intervention(s)
EXV-802PlaceboEXV-801
EXV-802: Specified dose twice daily
Placebo: Specified dose twice daily
EXV-801: Specified dose twice daily
Study 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
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
Primary outcome measure(s)
- Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score — Baseline to Week 6
The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviors while lower scores indicate lower frequency of agitated behaviors The CMAI-IPA includes 19 items that were mapped to IPA agitation domains. The total score ranges from 19 to 133 with higher scores indicating more severity.
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
+ 9 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07284472 on ClinicalTrials.gov ↗ ← All trials in Italy