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 UK tracker

Sponsor

Exciva GmbH

Phase

Phase 2/3

Started

2026-02-02

Last updated

2026-08-14

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

Sex

ALL

Min age

55 Years

Max age

90 Years

Healthy volunteers

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 the UK