EXV-802 and EXV-801 to treat agitation in Alzheimer's disease dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2/3, multicenter, double-blind, placebo-controlled, three-arm randomized trial will enroll about 300 participants across up to 60 sites in the US, Canada, and Europe. Participants must have a prior diagnosis of Alzheimer's disease dementia, clinically significant agitation meeting the International Psychogeriatric Association (IPA) definition, supporting neuroimaging after dementia onset, and a Core 1 AD biomarker. Eligible participants will be randomized roughly 1:1:1 to EXV-802, EXV-801, or placebo and followed for safety and changes in agitation symptoms. Caregivers must be available to provide regular contact and assist with study procedures.

Why it matters

Who can join: the full rules

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 a wheelchair.
2. A previously established diagnosis of AD dementia.
3. The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
5. 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:

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 not secondary to AD dementia
3. The participant has a history of uncontrolled seizures or a history of epilepsy.
4. The participant has a major medical illness or unstable medical condition

Where it's running

• Esperanza Clinical
  Murrieta, California, United States Recruiting
• Josephson Wallack Munshower Neurology PC
  Indianapolis, Indiana, United States Recruiting
• Precise Research Centers
  Flowood, Mississippi, United States Recruiting
• Integrative Clinical Trials
  Brooklyn, New York, United States Recruiting
• Manhattan Behavioral Medicine
  New York, New York, United States Recruiting
• Insight Clinical Trials
  Independence, Ohio, United States Recruiting

Study contacts

• Study coordinator: Exciva Clinical Studies
• Email: studies@exciva.com
• Phone: +49 6221-6479990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating ONO-2020 for agitation in Alzheimer's patients

  This study is testing if a new medication called ONO-2020 can help reduce agitation in people with Alzheimer's disease.

  Recruiting at 36 sites Phase 2 Ono Pharmaceutical Co., Ltd. · Aichi and 38 other locations · NCT06803823

• Evaluating ITI-1284 for treating agitation in Alzheimer's patients

  This study tests whether a new medication called ITI-1284 can help reduce agitation in people with Alzheimer's disease.

  Recruiting at 59 sites Phase 2 Intra-Cellular Therapies, Inc. · Anaheim, California and 70 other locations · NCT06651567

• Using virtual darkness to reduce agitation in dementia patients

  This study is testing if using virtual darkness can help reduce agitation in people with dementia.

  Recruiting University of Bergen · Askøy, Erdal · NCT06451952

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.