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

Phase 3RecruitingNCT07284472

Exciva GmbH300 enrolled

Overview

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.

This is a Phase 2/3 multicenter, double-blind, placebo-controlled, three-arm, multicenter study evaluating the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia. The diagnosis of agitation will be based on the consensus definition for agitation in patients with cognitive disorders developed by te International Psychogeriatric Association (IPA) Agitation Definition Work Group as well as neuroimaging performed after onset of dementia symptoms and a Core 1 AD biomarker. The study will be conducted at up to 60 centers in the US, Canada and Europe.. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study. Approximately 100 patients per arm will be randomized (300 total).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Agitation Associated With Alzheimer's Disease Dementia

Interventions

EXV-802DRUG

Specified dose twice daily

PlaceboDRUG

Specified dose twice daily

EXV-801DRUG

Specified dose twice daily

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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 (14)

Esperanza Clinical

Murrieta, California, United States

RECRUITING

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score

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.

Time frame: Baseline to Week 6

Secondary Outcomes

Changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score as related to symptoms of agitation

The CGI-S is an observer-rated scale that measures illness severity. The CGI-S is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = extremely ill) that assessed the severity of agitation in this study. Higher scores indicate severe agitation, while the lower scores indicate little or no agitation.

Time frame: Baseline to Week 6

Central Contacts

Exciva Clinical Studies

CONTACT

+49 6221-6479990 studies@exciva.com

Data from ClinicalTrials.gov

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