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: Not yet 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 learn if the investigational drugs EXV-802 and EXV-801 can safely and effectively reduce agitation in participants with Alzheimer's Disease Dementia.

Researchers will compare EXV-802 and EXV-801 with a placebo to see if EXV-802 and/or EXV-801 reduces agitation more effectively than the placebo.

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 with a wheelchair.
2. A previously established diagnosis of AD dementia.
3. The participant meets definition for agitation which require treatment with medicines.
4. The severity of agitation is at least moderate.

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 due to psychiatric conditions other than AD dementia.
3. The participant has a history of uncontrolled seizures or a history of epilepsy.
4. The participant lacks a caregiver or support person who attends regularly to the participants' needs.

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

Treatment:

Drug: EXV-802

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

EXV-801

Experimental group

Treatment:

Drug: EXV-801