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Tests treatment safety and results for Agitation Associated With Alzheimer's Disease Dementia
Official title Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
ClinicalTrials.gov ID: NCT07284472
What this study is testing
What is EXV-802?
EXV-802 is an investigational medicine, given as an once-daily, being studied as a potential treatment for agitation associated with alzheimer's disease dementia.
Also referred to as Dextromethorphan + EXV-801.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Murrieta, California, United States
- Indianapolis, Indiana, United States
- Flowood, Mississippi, United States
- Chesterfield, Missouri, United States
- Brooklyn, New York, United States
- New York, New York, United States
- Independence, Ohio, United States
- Portland, Oregon, United States
- Bennington, Vermont, United States
- North York, Ontario, Canada
- Peterborough, Ontario, Canada
- Whitby, Ontario, Canada
- Kladno, Central Bohemia, Czechia
- Hradec Králové, Hradec Králové Region, Czechia
- Pilsen, Plzeň Region, Czechia
- Brno, South Moravian, Czechia
- Böblingen, Baden-Wurttemberg, Germany
- Ebersberg, Bavaria, Germany
- München, Bavaria, Germany
- Berlin, State of Berlin, Germany
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Murrieta, California, United States; Indianapolis, Indiana, United States; Flowood, Mississippi, United States; Chesterfield, Missouri, United States; Brooklyn, New York, United States; New York, New York, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.