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Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia

NCT07284472

RecruitingPhase 2, Phase 3

Sponsor: Exciva GmbH

Conditions: Agitation Associated With Alzheimer's Disease Dementia

Interventions: EXV-802, Placebo, EXV-801

Countries: United States, Canada, Czechia, Germany, Italy, Poland, Slovakia, Spain

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 overview

Sex: ALL

Age: 55 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (49)
  • Murrieta, California, United States
  • Indianapolis, Indiana, United States
  • Flowood, Mississippi, United States
  • Chesterfield, Missouri, United States
  • Brooklyn, New York, United States
  • New York, New York, United States
  • Independence, Ohio, United States
  • Portland, Oregon, United States
  • Bennington, Vermont, United States
  • North York, Ontario, Canada
  • North York, Ontario, Canada
  • Peterborough, Ontario, Canada
  • Whitby, Ontario, Canada
  • Kladno, Central Bohemia, Czechia
  • Hradec Králové, Hradec Králové Region, Czechia
  • Pilsen, Plzeň Region, Czechia
  • Brno, South Moravian, Czechia
  • Böblingen, Baden-Wurttemberg, Germany
  • Ebersberg, Bavaria, Germany
  • München, Bavaria, Germany
  • Berlin, State of Berlin, Germany
  • Rome, Lazio, Italy
  • Rome, Lazio, Italy
  • Tricase, Lecce, Italy
  • Brescia, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Palermo, Sicily, Italy
  • Poznan, Greater Poland Voivodeship, Poland
  • Krakow, Lesser Poland Voivodeship, Poland
  • Wroclaw, Lower Silesian Voivodeship, Poland
  • + 19 more on CT.gov