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A study testing xanomeline tartrate and trospium chloride for treating agitation in patients 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 involves people who have Alzheimer's disease and are experiencing agitation, which means they may have behaviors such as restlessness, aggression, or emotional distress that are related to their condition. The treatments being tested in this study are KarXT, which is a capsule containing two substances called xanomeline tartrate and trospium chloride, and KarX-EC, which is a capsule containing only xanomeline tartrate. Some people in the study will receive these medications while others will receive placebo. The medications are also known by their code names BMS-986510 for KarXT and BMS-986519 for KarX-EC.

The purpose of this study is to find out if KarXT combined with KarX-EC works better than placebo in reducing agitation in people with Alzheimer's disease. During the study, the effectiveness of the treatment will be measured using a rating scale that tracks agitation behaviors, such as physical and verbal aggression, and how often these behaviors occur. Doctors will also assess the overall severity of agitation symptoms to see if there is improvement with the treatment.

People taking part in this study will need to have a caregiver who spends enough time with them each week to observe their symptoms and help them follow the study requirements. The caregiver will attend study visits and provide information about the person's agitation and overall condition. The study will involve taking the study medication or placebo in capsule form by mouth over a period of time, with regular visits to monitor safety and measure changes in agitation symptoms.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    You will be randomly assigned to receive either the study medication or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active treatment.

    The study medication is called KarXT, which contains xanomeline tartrate, combined with KarX-EC, which contains trospium chloride and xanomeline tartrate.

    This is a double-blind study, which means neither you nor your doctor will know whether you are receiving the active medication or placebo during the treatment period.

  2. Step 2

    Taking the study medication

    You will take the assigned medication by mouth in the form of capsules.

    Your caregiver will help ensure that you take the medication as prescribed and will monitor your compliance with the medication schedule.

    The exact dosage, frequency, and duration of treatment will be determined by the study doctor based on the study protocol.

  3. Step 3

    Regular study visits

    You will attend regular visits at the study site throughout the treatment period.

    Your caregiver must accompany you to all visits to provide information about your condition and behavior.

    During these visits, the study team will assess your agitation symptoms using standardized questionnaires and scales.

  4. Step 4

    Agitation assessments

    Your agitation symptoms will be measured using the CMAI-IPA scale. This scale evaluates different types of agitated behaviors, including physical and verbal aggression.

    The study team will also use the CGI-S scale, which is a rating of the overall severity of your agitation symptoms.

    Your caregiver will provide information about your behavior and any changes in your agitation symptoms since the previous visit.

  5. Step 5

    Safety monitoring

    Throughout the study, the medical team will monitor you for any side effects or adverse reactions to the medication.

    You should report any new symptoms or changes in your health to the study team.

    Your caregiver will also help monitor your condition and report any concerns to the study team.

  6. Step 6

    End of treatment

    At the end of the treatment period, you will have a final assessment to measure any changes in your agitation symptoms compared to the beginning of the study.

    The study team will evaluate the effectiveness of the treatment by comparing your scores on the CMAI-IPA and CGI-S scales from the start to the end of treatment.

    After completing the treatment phase, the study team will provide information about any follow-up procedures or next steps.

Who can join the trial?

9 criteria

  • Have a diagnosis of Alzheimer's disease, which is a brain condition that affects memory and thinking, confirmed by one of these special tests: a brain scan called amyloid PET, or blood or spinal fluid tests that look for specific proteins related to Alzheimer's disease
  • Score between 5 and 22 on the Mini-Mental State Examination, which is a test that measures memory and thinking abilities
  • Have one main caregiver who spends at least 10 hours per week with the patient and is willing to attend all study visits, help the patient take medications correctly, and answer questions about the patient's behavior and symptoms
  • Have a history of agitation, which means showing behaviors like restlessness, pacing, or becoming upset easily, that started at least two weeks before joining the study
  • Score 4 or higher on a specific agitation rating scale at two different study visits, showing that agitation symptoms are present
  • Score 4 or higher on the Clinical Global Impression-Severity scale, which measures how severe the agitation symptoms are, at two different study visits
  • Show at least one of these patterns of aggressive behavior at two different study visits: one or more aggressive behaviors happening several times per week, two or more aggressive behaviors happening once or twice per week, or three or more aggressive behaviors happening less than once per week
  • Be an adult or elderly person, as the study includes participants from these age groups
  • Both male and female patients can participate in this study

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed information about which conditions or situations would prevent participation, it is not possible to list the specific reasons that would make someone ineligible for this clinical trial
  • Typically, exclusion criteria might include certain medical conditions, medications being taken, or other health factors, but these specific details are not available in the provided information
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Investigated drugs

  • KarXT

    is an investigational medication being studied for the treatment of agitation in people with Alzheimer's disease. This medication is being tested to see if it can help reduce agitation symptoms such as restlessness, aggression, or other behavioral problems that may occur in patients with Alzheimer's disease.

  • KarX-EC

    is an investigational medication that is given together with KarXT in this study. It is designed to work alongside KarXT to help treat agitation associated with Alzheimer's disease. The combination of these two medications is being evaluated to determine if it is safe and effective in reducing agitation symptoms in study participants.

What is already known about the treatment

  • KarXT

    KarXT is an investigational medication currently being studied in clinical trials for treating agitation in people with Alzheimer's disease, meaning it has not yet received full approval for widespread medical use. This drug is administered along with KarX-EC, which helps reduce side effects, and works by targeting specific receptors in the brain called muscarinic receptors that help regulate mood and behavior. It belongs to a class of drugs known as muscarinic receptor agonists, which aim to restore balance in brain chemicals that become disrupted in Alzheimer's disease. The medication is being tested to see if it can safely and effectively reduce symptoms of agitation, such as restlessness and aggressive behavior, in patients suffering from this condition.

  • KarX-EC

    KarX-EC is an experimental companion medication given together with KarXT during clinical trials for agitation associated with Alzheimer's disease, and it is not yet approved for general medical use. This medication is taken orally and is specifically designed to block certain receptors outside the brain to minimize unwanted side effects that KarXT might cause in other parts of the body, such as the digestive system. It works as a peripheral muscarinic receptor antagonist, meaning it prevents KarXT from affecting areas outside the central nervous system while allowing the main drug to work effectively in the brain. By protecting patients from side effects, KarX-EC helps make the treatment safer and better tolerated during the study.

Investigated diseases

Alzheimer's Disease – Alzheimer's disease is a progressive brain disorder that gradually destroys memory and thinking skills. The disease occurs when abnormal protein deposits form in the brain, causing nerve cells to die. As the condition advances, individuals experience increasing difficulty with daily activities and communication. Memory loss typically begins with forgetting recent events and conversations. Over time, confusion, disorientation, and changes in behavior become more pronounced. In some cases, individuals may develop agitation, which involves restlessness, irritability, and emotional distress.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520612-34-00Protocol codeCN012-0024Estimated enrolment354 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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