NCT07284472 · Exciva GmbH
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
(SERENADA)
What this study is about
The goal of this clinical trial is to evaluate the safety and effectiveness of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Murrieta, California
- Indianapolis, Indiana
- Flowood, Mississippi
- Chesterfield, Missouri
- Brooklyn, New York
- New York, New York
- Independence, Ohio
- Portland, Oregon
- Bennington, Vermont
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations