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A study to evaluate the safety and effectiveness of dextromethorphan, deramciclane fumarate, and deramciclane in treating agitation in people with Alzheimer's disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the safety and effectiveness of two experimental medications, EXV-802 and EXV-801, for treating agitation in individuals living with Alzheimer’s disease dementia. Agitation refers to feelings of restlessness, irritability, or anxious behavior that can occur in people with this type of memory-related brain disorder. The medication EXV-802 contains a combination of dextromethorphan and deramciclane fumarate, while EXV-801 contains deramciclane. Participants in the study may receive one of these active treatments or a placebo.

The study follows a double-blind design, which means that neither the participants nor the researchers know who is receiving the active medication and who is receiving the placebo. This method is used to prevent bias in the results. During the course of the study, participants will take an oral capsule for a period of time to monitor how the medications affect their symptoms and general well-being.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    You will receive either exv-802, exv-801, or a placebo, which is an inactive substance that looks like the medicine.

    If assigned to exv-801, you will take 60 mg of deramciclane in a capsule form taken by mouth.

    If assigned to exv-802, you will take a capsule containing dextromethorphan and deramciclane fumarate by mouth.

    The medication administration phase lasts for 6 weeks.

  2. Step 2

    <b>monitoring and assessments</b>

    Throughout the 6-week period, different measurements are taken to monitor agitation, which refers to feelings of restlessness or being upset.

    Assessments include evaluating symptoms through tools like the cohen-mansfield agitation inventory and the clinical global impression of severity of illness score.

    Caregivers may be asked to provide information regarding irritability, sleep disorders, and distress related to aggression or agitation.

    Health monitoring includes physical examinations, checking vital signs (such as heart rate and blood pressure), electrocardiograms (tests that check the heart's electrical activity), and clinical laboratory values (tests of blood or other fluids).

    Cognitive and mental health screenings are performed using the mini-mental state examination (a test for memory and thinking) and the columbia suicide severity rating scale (a tool to check for thoughts of self-harm).

Who can join the trial?

5 criteria

  • You must be an adult male or female between the ages of 55 and 90 years.
  • You must be able to move around independently, either by walking on your own, using a walker (a device that helps you walk), or using a wheelchair.
  • You must have a previously confirmed diagnosis of Alzheimer's Disease dementia, which is a brain condition that affects memory, thinking, and behavior.
  • You must experience agitation, which refers to feeling restless, upset, or behaving in an anxious way, that is severe enough to require treatment with medicines.
  • The level of your agitation must be at least moderate, meaning it is more than mild but not yet extreme.

Who cannot join the trial?

4 criteria

  • The participant has a confirmed diagnosis of a type of dementia, which is a condition that causes a decline in memory and thinking skills, that is not Alzheimer's disease.
  • The participant experiences agitation, which refers to feelings of restlessness or nervousness, that is caused by a psychiatric condition, or a mental health disorder, other than Alzheimer's disease.
  • The participant has a history of epilepsy or uncontrolled seizures, which are sudden, uncontrolled electrical disturbances in the brain that can cause changes in behavior or movement.
  • The participant does not have a caregiver, which is a person who provides regular assistance and support, to help meet their daily needs.
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Investigated drugs

  • EXV-802

    is an oral capsule that combines two different medicines used to help treat agitation in people living with Alzheimer's disease.

  • EXV-801

    is an oral capsule containing a single medicine intended to help manage agitation in people living with Alzheimer's disease.

What is already known about the treatment

  • Dextromethorphan

    This medication is taken orally in a capsule form and is currently used widely in medicine as a cough suppressant. It belongs to a class of drugs that works by blocking certain signals in the brain to reduce the urge to cough. In this specific study, it is being investigated for its role in helping to manage agitation in people with Alzheimer's disease.

  • Deramciclane fumarate

    This substance is administered orally through a capsule and is currently being studied in clinical trials for its potential medical uses. It is classified as a medication that targets specific receptors in the nervous system to calm brain activity. Its primary goal in this research is to help reduce agitation and restlessness in patients living with Alzheimer's disease dementia.

Investigated diseases

Agitation in Alzheimer's Disease Dementia - This condition involves a state of restlessness, irritability, or emotional distress occurring in individuals with Alzheimer's disease. It often manifests as repetitive behaviors, pacing, or vocal outbursts. As the underlying dementia progresses, these behavioral symptoms may increase in frequency and intensity. The agitation can be triggered by various environmental factors or changes in the person's mental state. It represents a neuropsychiatric symptom that complicates the daily management of the primary cognitive decline.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517388-22-00Protocol codeEXV802-2-1Estimated enrolment324 patients

sourced from the EU Clinical Trials Register and site verification

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