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

Exciva GmbH

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Agitation Associated With Alzheimer's Disease Dementia

Treatments: Drug: EXV-801; Drug: Placebo; Drug: EXV-802

Study type: Interventional

Funder types: Industry

Identifiers

NCT07284472

2024-517388-22-00 (EU Trial (CTIS) Number)

EXV802-2-1

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

EXV-802

Experimental group

Description:

Participants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.

Treatment:

Drug: EXV-802

Placebo

Placebo Comparator group

Description:

Participants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.

Treatment:

Drug: Placebo

EXV-801

Experimental group

Description:

Participants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.

Treatment:

Drug: EXV-801