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Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer's-Related Psychosis

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 clinical trial is focused on studying the long-term safety and how well people tolerate a medication called KarXT in individuals experiencing psychosis associated with Alzheimer's disease. Psychosis in this context refers to symptoms like hallucinations or delusions that can occur in people with Alzheimer's disease. The medication being tested, KarXT, is taken in capsule form and contains two active substances: trospium chloride and xanomeline tartrate. These substances are designed to work together to help manage symptoms of psychosis.

The purpose of this study is to understand how safe KarXT is when used over a long period and how well it is tolerated by participants. Participants in the study will take the medication orally, meaning by mouth, in capsule form. The study will last for up to 52 weeks, during which participants will be monitored for any side effects or changes in their condition. Some participants may receive a placebo, which is a capsule that looks like the medication but does not contain the active substances.

Throughout the study, researchers will keep track of any side effects, known as treatment-emergent adverse events (TEAEs), that participants experience. They will also monitor for any serious side effects or any that might lead to stopping the medication. This information will help determine the long-term safety and tolerability of KarXT for people with psychosis associated with Alzheimer's disease. The study aims to provide valuable insights into the potential benefits and risks of using KarXT for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing a previous study, either KAR-031 or KAR-032.

    Eligibility includes being between 55 and 90 years old at the time of enrollment in the previous study.

    Understanding the study's nature and requirements is necessary, and informed consent must be provided. If unable to consent, a legally acceptable representative or caregiver must do so.

  2. Step 2

    Medication administration

    The medication used in the study is called KarXT, which is taken orally in the form of a capsule.

    KarXT contains the active substances trospium chloride and xanomeline tartrate.

    The dosage, frequency, and duration of administration are determined by the study protocol and will be communicated during the study.

  3. Step 3

    Monitoring and assessments

    Regular visits are required to monitor the long-term safety and tolerability of KarXT.

    A caregiver must attend all visits, oversee medication compliance, and participate in assessments.

    The study aims to observe any side effects, known as treatment-emergent adverse events (TEAEs).

  4. Step 4

    Completion of the study

    The study is estimated to end by June 30, 2026.

    Participants will be informed about the study's completion and any necessary follow-up actions.

Who can join the trial?

6 criteria

  • Must have completed study KAR-031 or KAR-032.
  • Must be between 55 to 90 years old at the time of joining the previous study (KAR-031 or KAR-032).
  • Must understand the study and agree to participate by signing a consent form. If unable to do so, a legal representative or caregiver must provide consent, and the participant must agree electronically or on paper.
  • If moving to a nursing home during the study, approval from the study's Sponsor or Medical Monitor is required to continue participation.
  • Must be able to move around by themselves, with or without help from a device, and have a caregiver who spends about 10 hours a week with them. The caregiver must attend all visits, help with medication and study tasks, and agree to participate in the study.
  • Female participants must not be pregnant or breastfeeding. Women who can have children, or men whose partners can have children, must use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication. Sperm donation is not allowed for 30 days after the last dose. A woman is considered able to have children from her first period until she has not had a period for 12 months or has had surgery to prevent pregnancy.

Who cannot join the trial?

5 criteria

  • Patients who do not have psychosis related to Alzheimer's Disease cannot participate. Psychosis means having trouble with reality, like seeing or hearing things that aren't there.
  • Patients who are not in the specified age range cannot participate. The age range includes older adults.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is defined by certain characteristics needed for the study.
  • Both men and women can participate, but if a patient does not meet other criteria, they cannot join.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need extra protection in a study.
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Investigated drugs

KarXT is a medication being studied for its potential to help people with psychosis related to Alzheimer's Disease. The trial aims to understand how safe and tolerable this medication is when used over a long period. KarXT is designed to target specific symptoms of psychosis, which can include hallucinations or delusions, and may help improve the quality of life for those affected by these symptoms.

What is already known about the treatment

KarXT – KarXT is administered orally in the form of tablets. It is currently being studied in clinical trials to evaluate its long-term safety and tolerability for treating psychosis associated with Alzheimer's Disease. The medication is primarily indicated for managing symptoms of psychosis in patients with Alzheimer's. KarXT works by modulating specific neurotransmitter receptors in the brain, which helps in reducing psychotic symptoms. It is classified as a neuropsychiatric medication, focusing on altering brain chemistry to improve mental health conditions.

Investigated diseases

Psychosis associated with Alzheimer's Disease – This condition involves experiencing symptoms of psychosis, such as hallucinations or delusions, in individuals diagnosed with Alzheimer's Disease. Alzheimer's Disease is a progressive neurological disorder that leads to memory loss and cognitive decline. As the disease advances, some individuals may develop psychotic symptoms, which can include seeing or hearing things that are not present or holding false beliefs. These symptoms can vary in intensity and may fluctuate over time. The presence of psychosis can complicate the management of Alzheimer's Disease, affecting the individual's behavior and interactions. Understanding and addressing these symptoms is crucial for improving the quality of life for those affected.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504151-27-00Protocol codeKAR-033Estimated enrolment320 patientsSponsorKaruna Therapeutics Inc.

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