EXV-802 + EXV-801 for Alzheimer's Disease

(SERENADA Trial)

Recruiting at 13 trial locations

Overseen By Exciva Clinical Studies

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Exciva GmbH

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 55 and 90 years old and can move around on my own or with help.

I have been diagnosed with agitation as defined by the IPA.

I have been diagnosed with Alzheimer's disease dementia.

Exclusion Criteria

I have symptoms of agitation not caused by Alzheimer's dementia.

Participant has a history of uncontrolled seizures or a history of epilepsy

I have been diagnosed with a dementia-related disease that is not Alzheimer's.

What Are the Treatments Tested in This Trial?

Interventions

• EXV-801
• EXV-802

How Is the Trial Designed?

Group I: EXV-802 Experimental Treatment 1 Intervention

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

Group II: EXV-801 Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Exciva GmbH

Lead Sponsor