EXV-802 and EXV-801 to treat agitation in Alzheimer's disease dementia
Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants With Alzheimer's Disease Dementia
This study will test whether two experimental medicines, EXV-802 and EXV-801, can reduce moderate-to-severe agitation in adults aged 55–90 with Alzheimer's disease dementia.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | Exciva GmbH Industry-sponsored |
| Locations | 14 sites (Murrieta, California and 13 other locations) |
| Trial ID | NCT07284472 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 55–90 years old with a prior diagnosis of Alzheimer's disease dementia, clinically significant moderate-to-severe agitation per the IPA definition, required AD biomarker/neuroimaging, and a caregiver who can participate in study visits are the intended participants.
Not a fit: People whose agitation is primarily due to a different condition or non-AD dementia, those with uncontrolled seizures or epilepsy, or those outside the age range or unable to attend study visits are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, these medicines could reduce agitation symptoms, improving daily life for patients and easing caregiver burden.
How similar studies have performed: Pharmacologic trials for agitation in Alzheimer's have produced mixed results and few new approved options, so this approach is somewhat novel and exploratory compared with existing off-label treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Murrieta, California and 13 other locations
- 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)
- Oregon Health & Science University — Portland, Oregon, United States (Not_yet_recruiting)
- The Memory Clinic — Bennington, Vermont, United States (Not_yet_recruiting)
- Sunnybrook Health Sciences Centre — North York, Ontario, Canada (Not_yet_recruiting)
- Baycrest Centre for Geriatric Care — North York, Ontario, Canada (Not_yet_recruiting)
- Kawartha Centre — Peterborough, Ontario, Canada (Not_yet_recruiting)
- Ontario Shores Centre for Mental Health Sciences — Whitby, Ontario, Canada (Not_yet_recruiting)
- Scottish Brain Sciences — Edinburgh, Midlothian, United Kingdom (Recruiting)
- Scottish Brain Sciences — Aberdeen, North East Scotland, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Exciva Clinical Studies
- Email: studies@exciva.com
- Phone: +49 6221-6479990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.