AuthorisedPhase II and Phase III (Integrated)Interventional

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 is investigating two potential new treatments, EXV-802 and EXV-801, for people living with Alzheimer's disease who struggle with agitation. Agitation can include restlessness, aggression, or distress. The main goal is to find out if these new medicines can help reduce these symptoms. Participants will be given either one of the new medicines or a 'dummy' pill called a placebo. This is to fairly compare if the medicines work better than no active treatment. Researchers will carefully monitor changes in agitation over six weeks, as well as checking how safe the medicines are and if they cause any side effects. This type of study is called a 'double-blind' trial, meaning neither the participants nor the doctors know who is receiving the actual medicine or the placebo.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Exciva GmbH

Enrolment target

222

Start

28 Apr 2026

Agitation in Alzheimer's Disease Dementia

What is this study about?

This research study is looking into two new experimental medicines, called EXV-802 and EXV-801. These medicines are being tested for their potential to help people who have Alzheimer's disease and experience agitation. Agitation can involve a range of distressing behaviours, such as restlessness, shouting, hitting out, or general distress. These symptoms can be very challenging for both the person with Alzheimer's and their carers.

The main aim of the study is to see if these new medicines can reduce agitation more effectively than a dummy pill (what doctors call a 'placebo'). Participants will be randomly given either EXV-802, EXV-801, or the placebo. Neither the patient nor their doctor will know which treatment they are receiving until the study is over. This is a common and important way to ensure the results are accurate and unbiased.

Over a period of six weeks, the research team will closely monitor changes in agitation using special questionnaires. They will also look at other important things, like overall changes in the patient's condition, how the agitation affects caregivers, and any effects on sleep or irritability. A very important part of the study is also to thoroughly check for any side effects and to make sure the medicines are safe for people to take.

Key takeaways

This study is testing two new medicines, EXV-802 and EXV-801, for symptoms of agitation in Alzheimer's disease.
It compares these medicines to a dummy pill (placebo) to see if they can effectively reduce agitation.
The study also carefully checks the safety of these new treatments and any side effects.
Neither patients nor doctors will know who is receiving the active medicine or the placebo during the study.
Participation involves taking medication for six weeks and attending several clinic visits for assessments.

Who may be eligible?

This study is open to both men and women, aged 18 years and older. There is no upper age limit for taking part.

To be eligible, you or the person you care for must have a diagnosis of Alzheimer's disease and be experiencing agitation. This would be carefully checked by the study doctors to make sure it fits the study's specific requirements.

There will also be other health checks and criteria to ensure the study is safe and suitable for you. These will be discussed in detail by the study team if you are interested in taking part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Do you have a diagnosis of Alzheimer's disease?
Are you currently experiencing agitation related to your Alzheimer's?
Are you, or the person you care for, able to attend regular clinic appointments?
Are you willing to potentially receive a dummy pill (placebo) instead of an active medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have several visits to the study clinic over about six weeks. These visits will involve various assessments, like filling out questionnaires about agitation and your general health. You will also have check-ups including blood tests, physical examinations, and possibly ECGs (heart rhythm checks) to monitor your health and safety.

You would receive either one of the study medicines (EXV-802 or EXV-801) or a matching dummy pill (placebo). You would be given instructions on how and when to take this study medication. Throughout the study, the research team will keep in close contact to monitor your progress and answer any questions. The total duration of the active treatment part of the study is six weeks, with follow-up assessments.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new experimental treatments not yet widely available, and close medical monitoring. However, there are also potential risks, like experiencing side effects from the study medication, or the treatment not being effective. It's also possible you could receive the placebo. Your safety and well-being are the top priority. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Slovakia
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Unverified
Spain
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Unverified
Poland
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Unverified
Czechia
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Unverified
Germany

Common questions

What is 'agitation' in this study?

Agitation in this study refers to restless or distressed behaviors sometimes seen in people with Alzheimer's, like pacing, shouting, or being easily upset.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredients. It helps researchers fairly compare how well the new medicine works.

Will I know if I'm getting the real medicine or the placebo?

No, neither you, your family, nor your doctor will know whether you are receiving the active medicine or the placebo during the study. This is called 'double-blind' and makes the study results more reliable.

How long will I take part in the study?

The main treatment phase of the study lasts for six weeks, during which you will take the study medicine or placebo and attend regular check-up appointments.

What happens if I want to stop participating?

You are free to stop participating in the study at any time, for any reason. Your decision will not affect your ongoing medical care.