NCT07284472 Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
| NCT ID | NCT07284472 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Exciva GmbH |
| Condition | Agitation Associated With Alzheimer's Disease Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2026-02-02 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07284472 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 90 Years, studying Agitation Associated With Alzheimer's Disease Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07284472 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07284472 currently recruiting?
Yes, NCT07284472 is actively recruiting participants. Contact the research team at studies@exciva.com for enrollment information.
Where is the NCT07284472 trial being conducted?
This trial is being conducted at Murrieta, United States, Indianapolis, United States, Flowood, United States, Chesterfield, United States and 11 additional locations.
Who is sponsoring the NCT07284472 clinical trial?
NCT07284472 is sponsored by Exciva GmbH. The trial plans to enroll 300 participants.
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