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Study of trospium chloride and xanomeline tartrate combination for agitation in Alzheimer's disease patients: Long-term safety evaluation

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What is this trial about?

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

This study focuses on testing medications called KarXT and KarX-EC in people who have Alzheimer's Disease with agitation - a condition where patients show signs of restlessness, emotional distress, and aggressive behavior. The purpose is to evaluate how safe these medications are and how well patients tolerate them when used for a long period.

The medications being tested contain active substances called trospium chloride and xanomeline tartrate. They come in the form of capsules that are taken by mouth. The study will involve patients who have previously participated in related research studies of these medications.

During the study, researchers will monitor various aspects of participants' health, including any side effects, changes in body weight, blood pressure, heart rate, and mental function. They will also check for any unusual movements, restlessness, and other health-related factors to ensure the medications' safety over extended use.

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 qualification

    To participate in this study, you must have completed either study CN0120023 or CN0120024

    You will need to sign a new informed consent form

    You must have a caregiver who can accompany you to all study visits, ensure medication compliance, and participate in behavioral assessments (approximately 10 hours per week)

  2. Step 2

    Medication administration

    You will receive oral capsules of KarXT and KarX-EC

    These medications contain active substances: trospium chloride and xanomeline tartrate

    The medication will be taken by mouth according to the prescribed schedule

  3. Step 3

    Regular monitoring

    Your health will be monitored through regular assessments including:

    Blood pressure and heart rate measurements

    Body weight checks

    Laboratory blood tests

    Evaluation of any unusual body movements or restlessness

    Assessment of cognitive function

    Monitoring of urinary function

    Mental health status checks

  4. Step 4

    Safety monitoring

    Any side effects or health changes will be recorded and monitored

    The study team will track any adverse events that may occur during treatment

    Special attention will be paid to specific health concerns related to the medication

  5. Step 5

    Study duration

    The study begins in November 2025

    The estimated completion date is July 2029

    Your participation will help evaluate the long-term safety of the medication for treating agitation in Alzheimer's Disease

Who can join the trial?

11 criteria

  • Must have completed participation in either study CN0120023 or CN0120024
  • Must be able to sign a new informed consent form showing agreement to participate in the study
  • Must have a dedicated caregiver who can:
    • Accompany the participant to all study visits
    • Ensure medication is taken as prescribed
    • Help follow study procedures
    • Participate in interviews about participant's behavior
    • Dedicate approximately 10 hours per week or more to these tasks
    • Both men and women can participate in the study
    • Must be an adult (age ranges included in the study are adults and elderly)
    • Must be capable of following study procedures and requirements
    • Must be willing to participate in interviews and complete questionnaires about behavior changes

Who cannot join the trial?

13 criteria

  • History of severe allergic reactions to medications similar to those used in the study
  • Current participation in other clinical trials or within 30 days before this study
  • Significant heart conditions or abnormal heart rhythm (diagnosed through ECG)
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • History of major psychiatric disorders other than Alzheimer's-related agitation
  • Current use of medications that could interact with the study drug
  • Presence of any medical condition that could interfere with the study results
  • Unable to comply with study procedures or follow-up visits
  • Substance abuse or alcohol dependency within the past year
  • Any unstable medical condition that requires immediate treatment
  • History of seizures or other neurological conditions besides Alzheimer's
  • Participation in an experimental drug trial within the last 3 months
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Investigated drugs

  • KarXT

    is an investigational medication being studied for treating agitation in people with Alzheimer's disease. It works by targeting specific brain receptors that may help control agitated behaviors and symptoms that are common in Alzheimer's patients.

  • KarX-EC

    is a supplementary medication used in combination with KarXT. It is being studied to understand how well these medications work together for long-term treatment of agitation symptoms in people with Alzheimer's disease.

What is already known about the treatment

  • KarXT

    A novel investigational medication being studied for the treatment of agitation associated with Alzheimer's Disease (AD). This compound is currently undergoing Phase 3 clinical trials to evaluate its long-term safety and tolerability. KarXT is being developed as an oral medication, and while its complete mechanism of action is still under investigation, it represents a potential new therapeutic option for managing behavioral symptoms in AD patients. The medication belongs to a new class of pharmaceuticals specifically designed to address the challenging neuropsychiatric symptoms that often accompany Alzheimer's Disease.

  • KarX-EC

    A complementary formulation being studied alongside KarXT in clinical trials for agitation associated with Alzheimer's Disease. This extended-release formulation is being evaluated in Phase 3 trials to determine its long-term safety profile when used in combination with KarXT. The medication is being developed as an oral preparation, and its primary purpose is to enhance or support the therapeutic effects of KarXT in managing agitation symptoms in Alzheimer's Disease patients.

Investigated diseases

  • Agitation Associated with Alzheimer's Disease

    A behavioral symptom that commonly occurs in people who have Alzheimer's disease, characterized by excessive psychomotor activity, emotional lability, and a heightened state of arousal. Patients may display restlessness, pacing, verbal aggression, and physical aggression. The condition tends to fluctuate throughout the day and often worsens in the late afternoon or evening. It typically develops as Alzheimer's disease progresses and can significantly impact daily activities and social interactions. The agitation may be triggered by environmental changes, confusion, or inability to communicate effectively.

  • Alzheimer's Disease

    A progressive brain disorder that slowly destroys memory, thinking skills, and the ability to carry out simple tasks. The disease begins with mild memory loss and confusion, gradually affecting various cognitive functions. Brain changes typically start years before the first symptoms appear. As the disease advances, individuals experience increasing difficulty with communication, reasoning, and judgment. The condition affects different parts of the brain, leading to various cognitive and behavioral changes over time.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519994-20-00Protocol codeCN012-0025Estimated enrolment602 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).