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RecruitingPhase 2/Phase 3

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

Exciva GmbH · NCT07284472

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
300
US sites recruiting
7
Study start
February 2, 2026
Record last updated
August 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: EXV-802; Placebo; EXV-801

Conditions: Agitation Associated With Alzheimer's Disease Dementia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Exciva Clinical Studies · +49 6221-6479990 · studies@exciva.com
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Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of… (NCT07284472) | Bored Studies