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Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated 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 focuses on psychosis that occurs in people with Alzheimer's disease. Psychosis involves experiencing things that are not real, such as seeing or hearing things that others do not (hallucinations) or having false beliefs (delusions). The study will test a medication called KarXT, which contains two active substances: trospium chloride and xanomeline tartrate. The purpose is to determine if KarXT can help reduce psychotic symptoms in people who have Alzheimer's disease.

During the study, participants will receive either KarXT capsules or placebo capsules to take by mouth. The medication or placebo will be given over a period of several weeks to determine if KarXT helps improve the psychotic symptoms that can occur with Alzheimer's disease. The study will compare how well KarXT works compared to the placebo in reducing these symptoms.

Before joining the study, participants will need to have brain imaging done using either magnetic resonance imaging (MRI) or computed tomography (CT) to confirm their diagnosis. Throughout the study, doctors will monitor the participants' symptoms and overall health to evaluate how well the treatment is working and ensure their safety.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and medication start

    You will begin taking KarXT or placebo (inactive substance) capsules orally. The assignment to either medication group is random.

    Your psychosis symptoms associated with Alzheimer's Disease will be evaluated using specific assessment tools.

  2. Step 2

    Treatment period

    You will continue taking the oral capsules throughout the study period.

    The medication contains a combination of two substances: trospium chloride and xanomeline tartrate.

    Regular evaluations will track changes in your hallucinations and delusions using a tool called NPI-C:H+D (a standardized assessment of mental health symptoms).

    Your overall condition will be monitored using a scale called CGI-S (a measure of symptom severity).

  3. Step 3

    Final evaluation

    At the end of the treatment period, your symptoms will be assessed one final time.

    The changes in your condition from the beginning to the end of treatment will be measured.

    The study is expected to conclude by February 27, 2026.

Who can join the trial?

7 criteria

  • Must be between 55 and 90 years old
  • Must have a confirmed diagnosis of Alzheimer's Disease according to the 2024 National Institute on Aging – Alzheimer's Association criteria with biomarker confirmation
  • Must have had a brain scan (either MRI or CT) within the past 5 years since dementia onset to rule out other brain conditions (such as stroke, tumors, or bleeding under the skull)
  • Must have experienced psychotic symptoms (such as hallucinations or delusions) for at least 2 months before the initial screening visit
  • Both men and women can participate in the study
  • The brain scan must have been done after dementia symptoms started
  • Must be able to undergo required medical tests and evaluations during the study

Who cannot join the trial?

13 criteria

  • History of schizophrenia or other psychotic disorders not related to Alzheimer's Disease
  • Current use of antipsychotic medications (medications used to treat psychosis symptoms)
  • Severe or unstable medical conditions that could interfere with study participation
  • History of seizures within the past year
  • Significant heart problems or abnormal heart rhythm
  • Active substance abuse or dependence within the past 6 months
  • Previous participation in clinical trials involving investigational drugs within 30 days
  • Severe kidney or liver problems
  • Unable to comply with study procedures or visits
  • Current thoughts of self-harm or history of suicide attempts in the past 6 months
  • Taking medications that could interact with the study drug
  • Presence of other neurological disorders besides Alzheimer's Disease
  • Inability to provide informed consent (either directly or through a legal representative)
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Investigated drugs

KarXT is an investigational medication being studied for treating psychosis symptoms (such as hallucinations and delusions) in people with Alzheimer's disease. It is designed to help reduce psychiatric symptoms that can occur in Alzheimer's patients without causing some of the common side effects associated with current antipsychotic medications. The trial also includes a placebo, which is an inactive substance used to compare the effects of the actual medication.

What is already known about the treatment

KarXT - A novel investigational drug being studied for the treatment of psychosis associated with Alzheimer's Disease, administered orally. This medication combines xanomeline (a muscarinic agonist) with trospium (a muscarinic antagonist) to target specific receptors in the brain while reducing peripheral side effects. KarXT works by selectively activating M1 and M4 muscarinic receptors in the central nervous system, which are believed to play a crucial role in managing psychotic symptoms. Currently in Phase 3 clinical trials, this medication represents a potential new approach to treating hallucinations and delusions in Alzheimer's patients without the significant side effects associated with traditional antipsychotics.

Investigated diseases

Psychosis Associated with Alzheimer's Disease – A condition that occurs in some people with Alzheimer's disease where patients experience hallucinations and delusions. Hallucinations involve seeing, hearing, or feeling things that are not actually present, while delusions are false beliefs that persist despite evidence to the contrary. This condition typically develops as Alzheimer's disease progresses, causing significant changes in perception and thought processes. The symptoms can include seeing nonexistent people or objects, hearing voices, or having persistent unfounded suspicions about family members or caregivers. These psychotic symptoms can fluctuate in intensity over time and may become more pronounced in the later afternoon or evening.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516363-92-00Protocol codeCN0120056Estimated enrolment358 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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