At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- EXV-802 (drug), Placebo (drug), EXV-801 (drug)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- EXV-802 — drug: Specified dose twice daily · Placebo — drug: Specified dose twice daily · EXV-801 — drug: Specified dose twice daily
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing two medicines, called EXV-802 and EXV-801, to see if they are safe and help people with agitation linked to dementia caused by Alzheimer's disease. Agitation here means moderate or severe restlessness or distress. The study is run and paid for by a company called Exciva GmbH.
Who can take part
- Adults aged 55 to 90, male or female, who can move around on their own, with a walker, or in a wheelchair.
- An existing diagnosis of dementia caused by Alzheimer's disease.
- Moderate or severe agitation that has been present at the screening check and for at least 2 weeks before joining the study.
- The agitation matches the description set out by the International Psychogeriatric Association (IPA).
- A caregiver who is willing and able to follow all study steps, and who is with the participant on at least 4 separate days a week for at least 2 hours each day.
Who may not be able to
- A confirmed main diagnosis of a dementia that is not caused by Alzheimer's disease.
- Agitation that is not caused by Alzheimer's disease dementia.
- A history of epilepsy or of seizures (fits) that are not controlled.
- A major illness or a medical condition that is not stable.
What taking part involves
- • Taking part involves treatment with the study medicines EXV-802 and EXV-801.
- • How the medicines are given (for example, as a tablet or an injection), the dose, and how long they are taken for — Not stated — ask the trial team.
- • Whether some people receive a dummy medicine (placebo) instead — Not stated — ask the trial team.
Time commitment: How many visits there are and how long the study lasts — Not stated — ask the trial team; a caregiver must be with the participant for at least 2 hours a day on at least 4 days a week and follow all study steps.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 55 Years to 90 Years
- Who
- All
- Number of participants
- 300
- Started
- 2026-02-02
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for agitation associated with alzheimer's disease dementia
- • Phase2/Phase3 - 300 participants
- • 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 take part?
- • Ages 55 Years to 90 Years
- • Diagnosed with agitation associated with alzheimer's disease dementia
Where?
- • Edinburgh - Scottish Brain Sciences
- • Aberdeen - Scottish Brain Sciences
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a Phase 2/3 multicenter, double-blind, placebo-controlled, three-arm, multicenter study evaluating the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia. The diagnosis of agitation will be based on the consensus definition for agitation in patients with cognitive disorders developed by te International Psychogeriatric Association (IPA) Agitation Definition Work Group as well as neuroimaging performed after onset of dementia symptoms and a Core 1 AD biomarker. The study will be conducted at up to 60 centers in the US, Canada and Europe.. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study. Approximately 100 patients per arm will be randomized (300 total).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 55 Years - 90 Years
- Who can join: All genders
What the study is looking for
- ✓The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by...
- ✓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...
- ✓The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of...
- ✓Caregiver who is able and willing to comply with all required study procedures and who is in contact with the...
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
Scottish Brain Sciences
Edinburgh EH12 5PJ, United Kingdom
Scottish Brain Sciences
Aberdeen AB25 2XE, United Kingdom
How to Get in Touch
Exciva Clinical Studies
Sponsor contactCONTACT