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A study to evaluate the effect of xanomeline tartrate and trospium chloride on cognitive impairment in adults with schizophrenia.

Verified siteInvestigationalNo placebo
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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 individuals living with Schizophrenia, a mental health disorder that can affect how a person thinks, feels, and behaves. A major aspect of this condition is cognitive impairment, which refers to difficulties with mental processes such as memory, attention, and problem-solving. The research aims to evaluate the effectiveness of a new medication called KarXT, which contains two active substances: xanomeline tartrate and trospium chloride. This medication is taken in the form of an oral capsule.

The purpose of the study is to determine if KarXT can improve mental functions in adults with this condition. During the study, participants will take different doses of the medication over a period of time. The process involves monitoring changes in mental abilities and other symptoms over 24 and 52 weeks to see how the treatment works over the long term.

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

    Participation in the study

    The study begins with the administration of the test medication, which contains xanomeline tartrate and trospium chloride. this medication is provided in capsule form and is taken by mouth (oral).

    The specific dose of the capsule may be 100 mg, 200 mg, or 250 mg.

  2. Step 2

    Treatment period

    The medication is taken for a total duration of up to 52 weeks.

    At the 24-week mark, an assessment of cognitive function (the ability to think, learn, and remember) is conducted using a tool called the BACS composite score.

    At the 24-week mark, an evaluation of negative symptoms (such as reduced emotional expression or lack of motivation) is also performed using the PANSS negative subscale.

  3. Step 3

    Completion of the study

    The final assessment of cognitive function is performed at the end of the 52-week treatment period.

Who can join the trial?

8 criteria

  • You must be between 18 and 55 years old.
  • You must be willing and able to agree to participate in the study after all the details have been explained to you. This includes being able to understand the informed consent, which is a formal document that explains all the risks and benefits of the study before you decide to join.
  • You must have a diagnosis of schizophrenia, which is a long-term mental health condition, that has been confirmed by a specific clinical interview called the MINI.
  • Your symptoms, as measured by specific medical rating scales called PANSS and G8/G10, must fall within a certain required range.
  • You must have been taking a stable dose of oral antipsychotic medication (pills used to manage symptoms of psychosis) for at least 4 weeks before the start of the study.
  • You must be taking only one type of antipsychotic medication, which is known as monotherapy, at the time of your first visit.
  • Your score on the SCIP, which is a test used to measure how much the condition affects your daily life, must be below 70.
  • If you are a female who is able to become pregnant, you must have a negative pregnancy test at the start of the study and must use a highly effective contraceptive method (a reliable way to prevent pregnancy) during the study and for 30 days after it ends.

Who cannot join the trial?

19 criteria

  • You are pregnant, breastfeeding, or have given birth within the last 3 months.
  • You currently meet the medical definitions for a manic episode (a period of extremely high energy or mood) or major depressive disorder (a period of severe sadness or low mood) as confirmed by a specific clinical interview.
  • You currently have a severe substance use disorder (addiction to drugs) or alcohol use disorder (addiction to alcohol) as confirmed by a clinical interview.
  • Your urine tests show the presence of phencyclidine, amphetamines, opiates (unless you have a valid prescription for short-term use), cocaine, or alcohol.
  • You have an intellectual disability (limitations in mental functioning), drug-induced psychosis (mental health symptoms caused by drug use), or a history of significant brain trauma (injury to the brain).
  • You are currently using, or have recently used, clozapine (a specific type of medication for mental health) for at least 6 weeks, or you use long-acting injectable antipsychotics (medications given by injection that last a long time), or anticholinergic treatment (medications that block certain nerve signals) that you cannot stop before the study starts.
  • You will need more than the allowed amount of psychotropic concomitant medication (other mental health medicines used alongside the study drug), such as high doses of benzodiazepines (medications used for anxiety or sleep), quetiapine (an antipsychotic), or antidepressants. Note that stable use of mood stabilizers (medications used to level out extreme moods) is allowed if the dose has been the same for at least 4 weeks.
  • You have a known allergy to xanomeline, trospium chloride, or any other ingredients in the study drug.
  • You have significant abnormal results from a physical examination, medical history review, ECG (a test that records the electrical activity of your heart), or laboratory tests.
  • You have participated in cognitive remediation (brain training programs) or completed the BACS (a specific test of brain function) within the last 4 weeks.
  • You have serious medical conditions affecting your cardiovascular (heart), pulmonary (lungs), renal (kidneys), hematologic (blood), gastrointestinal (stomach and intestines), endocrine (hormones), immunologic (immune system), dermatologic (skin), neurologic (nervous system), or oncologic (cancer) systems.
  • You have a history or high risk of urinary retention (difficulty emptying the bladder).
  • You have hepatic impairment (liver damage) of any level, or high levels of hepatic transaminases (liver enzymes that show liver stress) or bilirubin (a yellow substance in the blood) in your blood tests.
  • You have a history or high risk of narrow-angle glaucoma (a serious condition involving eye pressure).
  • You have active biliary disease (problems with the gallbladder or bile ducts, such as gallstones) or a history of bladder stones or frequent urinary tract infections.
  • For men, your serum prostate-specific antigen (a protein produced by the prostate) is higher than 10 ng/mL, or you have specific scores on the IPSS (a questionnaire used to check prostate health) that indicate prostate issues.
  • Your eGFR (a measure of how well your kidneys filter blood) is less than 60 mL/min, which indicates renal dysfunction (kidney problems).
  • You have a history of unstable hypertension (high blood pressure) or tachycardia (a heart rate that is too fast) at the time of the screening.
  • You are at a significant risk of suicide, defined as having active thoughts of suicide with an intent or a specific plan, as determined by a clinical assessment.
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Investigated drugs

KarXT is an oral capsule being tested to see if it can help improve thinking, memory, and attention in adults with schizophrenia.

What is already known about the treatment

KarXT - This medication is taken orally in the form of a capsule to help treat symptoms of schizophrenia. It is currently being studied in clinical trials to evaluate its effectiveness in improving thinking and memory problems. The treatment works by combining two substances that target specific receptors in the brain to balance chemical signals, while one component helps prevent unwanted side effects in the rest of the body. It is classified as a new type of antipsychotic medication that works through the cholinergic system rather than traditional pathways.

Investigated diseases

Schizophrenia - This is a mental disorder that affects how a person thinks, feels, and behaves. It often involves a disconnection from reality, which can cause people to see or hear things that are not there. Symptoms can include unusual beliefs or difficulty organizing thoughts and speech. Over time, it may also lead to a decrease in motivation or a reduction in social interaction. The condition can progress through different stages, impacting various aspects of daily functioning.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523060-20-00Protocol codeSHINEEstimated enrolment171 patientsSponsorEuropean Group for Research in Schizophrenia Stichting

sourced from the EU Clinical Trials Register and site verification

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