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Study of KarXT (trospium chloride and xanomeline tartrate) and KarX-EC (xanomeline tartrate) for cognitive impairment in mild to moderate 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 aims to test the effectiveness of medications called KarXT and KarX-EC in treating thinking and memory problems in people with Alzheimer's Disease. These medications contain active substances called trospium chloride and xanomeline tartrate, which are taken as capsules by mouth.

The study will involve people with mild to moderate Alzheimer's Disease, who will receive either the study medications or placebo for 24 weeks. The medications are being tested to see if they can help improve cognitive function (thinking abilities) and daily functioning in people with Alzheimer's Disease.

During the study, participants will take the medication daily and attend regular check-ups where their mental abilities and overall condition will be assessed. The study will track any changes in participants' ability to think, perform daily activities, and their overall health status. Healthcare providers will monitor participants' safety throughout the study period.

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 screening

    You will undergo screening to confirm if you meet the study requirements for mild to moderate Alzheimer's Disease

    Your thinking abilities will be tested using the MMSE test (a standard memory and thinking assessment). Your score should be between 12 and 22

    You must be between 60 and 85 years old to participate

    You need to have a caregiver who spends at least 10 hours per week with you and can attend all study visits

  2. Step 2

    Medication requirements check

    If you are currently taking memory medications (AChEIs and/or memantine), you must have been on a stable dose for at least 12 weeks

    You will need to maintain this same dose throughout the study

  3. Step 3

    Treatment period

    The study will last 24 weeks (approximately 6 months)

    You will receive either KarXT + KarX-EC capsules or placebo capsules (inactive treatment)

    The medication will be taken by mouth

    Your caregiver will help ensure you take the medication as prescribed

  4. Step 4

    Monitoring and assessments

    Your thinking abilities will be tested regularly using the ADAS-Cog11 test

    Your daily activities will be assessed using the ADCS-ADL assessment

    Your behavior will be evaluated using the NPI assessment

    Regular health checks will include vital signs, heart tests (ECG), weight measurements, and laboratory tests

    Any side effects or health changes will be monitored throughout the study

  5. Step 5

    Final assessment

    At week 24, final assessments will be conducted to measure changes in your thinking abilities and overall function

    Your caregiver will provide information about changes in your daily activities and behavior

Who can join the trial?

9 criteria

  • Must be between 60 and 85 years old, both men and women can participate
  • Must have a MMSE score between 12 and 22 during screening (MMSE is a simple test that checks memory and thinking skills)
  • Must have a dedicated caregiver who:
    • Spends at least 10 hours per week with the participant
    • Can attend all study visits
    • Will help monitor the participant's condition
    • Will help with taking medications
    • Will ensure study procedures are followed
    • If currently taking memory medications (AChEIs and/or memantine):
      • Must have been on the same dose for at least 12 weeks before screening
      • Must agree to stay on the same dose throughout the study

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions or sensitivity to similar medications
  • Current diagnosis of major psychiatric disorders (such as schizophrenia, bipolar disorder, or severe depression)
  • Significant heart problems or uncontrolled high blood pressure
  • Severe liver or kidney disease
  • History of seizures or other neurological conditions besides Alzheimer's Disease
  • Current use of medications that could interact with the study drug
  • Participation in another clinical trial within the past 30 days
  • Inability to follow study procedures or attend regular visits
  • Substance abuse within the past year
  • Dementia caused by conditions other than Alzheimer's Disease
  • Severe vitamin B12 or folate deficiency
  • History of stroke or transient ischemic attack (temporary stroke-like symptoms) in the past 6 months
  • Unstable medical conditions that could interfere with the study
  • Presence of any medical devices that would prevent brain imaging if needed
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Investigated drugs

  • KarXT

    is an investigational medication being studied for treating cognitive impairment (problems with thinking and memory) in people who have mild to moderate Alzheimer's disease. It works by targeting specific brain receptors that are involved in cognitive function.

  • KarX-EC

    is a complementary medication being studied alongside KarXT. Together, these medications are being tested to see if they can help improve thinking abilities and daily functioning in people with Alzheimer's disease.

What is already known about the treatment

  • KarXT

    An investigational oral medication being studied for cognitive impairment in Alzheimer's Disease. It represents a novel therapeutic approach combining xanomeline and trospium chloride, designed to target specific brain receptors while minimizing peripheral side effects. The medication works by modulating muscarinic receptors in the brain, which are involved in memory and cognitive function, potentially helping improve thinking skills and daily functioning in people with mild to moderate Alzheimer's Disease. Currently in Phase 3 clinical trials, this drug is being evaluated as a potential treatment option that could offer a new mechanism of action in addressing cognitive decline in Alzheimer's patients.

  • KarX-EC

    A complementary investigational medication being studied alongside KarXT for treating cognitive impairment in Alzheimer's Disease. This extended-release formulation is designed to work in conjunction with KarXT to potentially enhance its therapeutic effects while maintaining a favorable safety profile. The medication is currently being evaluated in Phase 3 clinical trials as part of a combination therapy approach, with the goal of improving cognitive function and global functioning in patients with mild to moderate Alzheimer's Disease.

Investigated diseases

Alzheimer's Disease - A progressive brain disorder that gradually destroys memory, thinking skills, and the ability to carry out simple tasks. The disease begins with mild memory loss and confusion, which slowly becomes more severe over time. In mild to moderate stages, people experience increasing problems with memory, planning, language, and spatial awareness. The condition affects the parts of the brain that control thought, memory, and language. During these stages, individuals may have difficulty remembering recent events, following conversations, and managing daily activities. Changes in mood and personality may also occur, with some people becoming anxious, suspicious, or easily upset.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520747-32-00Protocol codeCN012-0052Estimated enrolment586 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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