RecruitingPhase 2/3

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

United States, Canada, Czechia300 participantsStarted 2026-02-02

Plain-language 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.

Who can participate

Age range

55 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. A previously established diagnosis of AD dementia.
. The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
. 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

. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
. The participant has symptoms of agitation that are not secondary to AD dementia
. The participant has a history of uncontrolled seizures or a history of epilepsy.
. The participant has a major medical illness or unstable medical condition

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to Week 6

Trial details

NCT IDNCT07284472

SponsorExciva GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Exciva Clinical Studies

+49 6221-6479990 studies@exciva.com

View on ClinicalTrials.gov More Agitation Associated With Alzheimer's Disease Dementia trials