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Study of xanomeline tartrate and trospium chloride combination for treating agitation in Alzheimer's disease patients

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What is this trial about?

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

This clinical trial aims to test the effectiveness of medications called KarXT and KarX-EC in treating agitation in people with Alzheimer's Disease. Agitation is a common symptom in Alzheimer's Disease that includes restlessness, emotional distress, and aggressive behavior. The medications being studied contain active substances called xanomeline tartrate and trospium chloride, which are taken as capsules by mouth.

The study will compare these medications to placebo to see if they can help reduce agitation symptoms in people with Alzheimer's Disease. During the study, participants will be randomly assigned to receive either the study medications or placebo. Neither the participants nor their doctors will know which treatment they are receiving.

The main way of measuring if the treatment works will be through a special rating scale that measures agitation behaviors. Throughout the study, participants will need to have a caregiver who spends at least 10 hours per week with them to help monitor their condition and assist with taking the medication correctly.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo evaluation to confirm your Alzheimer's disease diagnosis through specific tests that measure protein markers in your blood or brain scans if needed.

    Your mental status will be assessed using a standard examination with a score range of 5 to 22.

    Your level of agitation will be evaluated using specific assessment tools to ensure it meets the study criteria.

  2. Step 2

    Caregiver confirmation

    Your caregiver must be identified and confirmed to spend at least 10 hours per week with you.

    The caregiver will need to attend all visits and help with medication management.

    The caregiver will participate in assessments throughout the study.

  3. Step 3

    Treatment period

    You will receive either KarXT with KarX-EC capsules or a placebo (inactive capsules) to take by mouth.

    The medication or placebo will be given according to a specific schedule that will be provided.

    Neither you nor your doctor will know whether you are receiving the actual medication or placebo.

  4. Step 4

    Regular assessments

    Your agitation levels will be monitored regularly using specific rating scales.

    Your overall condition will be evaluated throughout the study period.

    The study will track changes in your behavior and agitation symptoms compared to when you started.

  5. Step 5

    Study completion

    The study will continue until the end of the prescribed treatment period.

    Final assessments will be conducted to measure changes in your agitation levels.

    Your overall response to the treatment will be evaluated using standardized measurements.

Who can join the trial?

15 criteria

  • You must have a confirmed diagnosis of Alzheimer's disease (AD) with evidence from one of these tests:
    • Previous brain scan showing amyloid deposits (amyloid PET scan)
    • Previous spinal fluid test showing specific protein markers
    • Blood test showing specific protein markers
    • Your score on the Mini-Mental State Examination (MMSE), which is a test that measures thinking and memory abilities, must be between 5 and 22
    • You must have a dedicated caregiver who:
      • Spends at least 10 hours per week with you
      • Can attend all study visits with you
      • Will help you take medications as prescribed
      • Agrees to participate in study assessments
      • You must have shown signs of agitation for at least two weeks before starting the study
      • You must have a certain level of agitation as measured by specific medical tests:
        • A score of 4 or higher on the NPI Agitation/Aggression scale
        • A score of 4 or higher on the CGI-S scale for agitation
        • You must show at least one of these behavioral patterns:
          • One or more aggressive behaviors several times per week
          • Two or more aggressive behaviors once or twice per week
          • Three or more aggressive behaviors less than once per week
          • Both men and women may participate in the study

Who cannot join the trial?

15 criteria

  • History of schizophrenia or other psychotic disorders
  • Severe kidney disease requiring dialysis treatment
  • Current diagnosis of major depressive disorder
  • Known allergy or sensitivity to the study medication components
  • Participation in another clinical trial within the past 30 days
  • Unstable medical conditions that could interfere with the study procedures
  • History of substance abuse within the past 12 months
  • Use of prohibited medications that might interact with the study drug
  • Severe liver disease or abnormal liver function tests
  • History of seizures or other significant neurological conditions
  • Inability to comply with study procedures due to severe cognitive impairment
  • Presence of any condition that, in the investigator's opinion, would make participation unsafe
  • Uncontrolled high blood pressure or significant heart problems
  • History of severe allergic reactions to medications
  • Pregnant women or women planning to become pregnant during the study period
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Investigated drugs

  • KarXT

    and KarX-EC are investigational medications being studied for treating agitation in people with Alzheimer's disease. These medications are being tested together as a combination therapy.

  • KarXT

    is an experimental drug that works in the brain to help control agitated behaviors that can occur in people with Alzheimer's disease. This medication aims to reduce symptoms like restlessness, aggression, and emotional distress.

  • KarX-EC

    is designed to work together with KarXT. The EC in its name likely indicates it has a special coating that controls how the medication is released in the body. It is being studied to see if it can enhance or complement the effects of KarXT in managing agitation symptoms.

What is already known about the treatment

  • KarXT

    A novel investigational medication administered orally that is being studied for the treatment of agitation in patients with Alzheimer's Disease. This drug combines xanomeline (a muscarinic receptor agonist) with trospium (a muscarinic receptor antagonist) to create a unique therapeutic approach. KarXT works by selectively targeting certain muscarinic receptors in the brain while reducing peripheral cholinergic side effects, making it a promising candidate for managing behavioral symptoms in Alzheimer's patients. Currently in Phase 3 clinical trials, this medication represents a potential new treatment option in the challenging field of Alzheimer's disease management.

  • KarX-EC

    An extended-release formulation being tested in combination with KarXT for the treatment of agitation associated with Alzheimer's Disease. This medication is designed to provide prolonged drug release and potentially improve the overall therapeutic effect when used alongside KarXT. The extended-release formulation aims to maintain steady drug levels in the body, which may help provide more consistent symptom control throughout the day. Currently being evaluated in Phase 3 clinical trials, this combination therapy represents an innovative approach to managing behavioral symptoms in Alzheimer's patients.

Investigated diseases

Agitation Associated with Alzheimer's Disease - A behavioral symptom that commonly occurs in people with Alzheimer's disease, characterized by restlessness, emotional distress, and various forms of disruptive behavior. Patients may exhibit physical aggression, verbal outbursts, resistance to care, wandering, or repetitive actions. The condition typically fluctuates in severity throughout the day and tends to worsen as Alzheimer's disease progresses. This behavioral disturbance can manifest as pacing, repeated movements, or constant demands for attention. The agitation often becomes more pronounced in unfamiliar environments or during times of stress.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520613-31-00Protocol codeCN012-0023Estimated enrolment354 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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