RecruitingPhase 2/3

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

United States300 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 range55 Years – 90 Years

SexALL

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

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