EXV-802 and EXV-801 for agitation in people with Alzheimer's disease dementia
Tests EXV-802 and EXV-801 against placebo for agitation in Alzheimer's disease dementia.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Key facts
- Where
- Brescia, Chieti Scalo, Milan, Palermo, Rome, and Tricase, ItalySee the 7 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
Source: NCT07284472, who can take part
Where in Italy
- Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio FatebenefratelliBrescia, ItalyTaking people
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
- Pia Fondazione Di Culto E Religione Card G PanicoTricase, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Exciva GmbH
- Trial code
- NCT07284472EU 2024-517388-22-00
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.