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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Agitation Associated With Alzheimer's Disease Dementia

In brief

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.

Key facts

Study ID

NCT07284472

Run by

Exciva GmbH

People needed

300

Starts

2026-02-02

Expected to finish

2029-02-01

Last updated by the study team

2026-06-05

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Esperanza Clinical — Murrieta, California, United States (enrolling)
• Josephson Wallack Munshower Neurology PC — Indianapolis, Indiana, United States (enrolling)
• Precise Research Centers — Flowood, Mississippi, United States (enrolling)
• Integrative Clinical Trials — Brooklyn, New York, United States (enrolling)
• Manhattan Behavioral Medicine — New York, New York, United States (enrolling)
• Insight Clinical Trials — Independence, Ohio, United States (enrolling)
• The Memory Clinic — Bennington, Vermont, United States (enrolling)
• Kawartha Centre — Peterborough, Ontario, Canada (enrolling)
• Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres — Böblingen, Baden-Wurttemberg, Germany (enrolling)
• Silmedic Sp. z o.o. — Katowice, Silesian Voivodeship, Poland (enrolling)
• Velocity Clinical Research, Staszów — Staszów, Świętokrzyskie Voivodeship, Poland (enrolling)
• Hospital Clinico San Carlos — Madrid, Spain (enrolling)
• Scottish Brain Sciences — Edinburgh, Midlothian, United Kingdom (enrolling)
• Scottish Brain Sciences — Aberdeen, North East Scotland, United Kingdom (enrolling)
• NeuropsychiatrieHK, sro — Hradec Králové, Hradec Králové Region, Czechia
• Psychiatrie-Ambulance s.r.o — Pilsen, Plzeň Region, Czechia
• FNUSA - St. Anne's University Hospital Brno — Brno, South Moravian, Czechia
• Hospital Universitario Rio Hortega — Valladolid, Castille and León, Spain
• Curiositas ad sanum Studien und Beratungs GmbH — Ebersberg, Bavaria, Germany
• TUM Klinikum rechts der Isar — München, Bavaria, Germany
• Praxis Dr. med. Kirsten Hahn — Berlin, State of Berlin, Germany
• 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
• IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli — Brescia, Lombardy, Italy

Full record on ClinicalTrials.gov

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