Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of xanomeline tartrate and trospium chloride combination for cognitive impairment in people with mild to moderate Alzheimer's disease

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial aims to test a combination 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 xanomeline tartrate and trospium chloride, which will be given as capsules taken by mouth. Some participants will receive the actual medications while others will receive a placebo.

The study will focus on people who have mild to moderate Alzheimer's Disease, which is a brain condition that affects memory, thinking, and behavior. The medications will be tested to see if they can help improve cognitive function (thinking and memory skills) and overall daily functioning in people with this condition.

During the study, which will last 24 weeks, participants will take the study medications or placebo daily. Healthcare providers will monitor participants' thinking abilities, daily functioning, and overall condition throughout the study period. They will also check for any side effects or safety concerns that may occur during treatment.

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 assessment

    You will undergo an evaluation to confirm your eligibility for participation in the study of mild to moderate Alzheimer's disease

    A screening test called MMSE will be conducted to assess your cognitive function. Your score should be between 12 and 22 to participate

    Your designated caregiver must be present during this visit

  2. Step 2

    Medication assignment

    You will be randomly assigned to receive either KarXT+KarX-EC or a placebo

    The medication will be in capsule form and taken orally

    If you are currently taking other Alzheimer's medications, you will continue them at the same dose

  3. Step 3

    Treatment period

    The treatment period will last for 24 weeks

    Your caregiver will help ensure proper medication intake and attend all study visits with you

    Regular assessments will monitor your thinking skills and daily functioning

  4. Step 4

    Regular monitoring

    Throughout the study, you will undergo regular health checks including:

    Vital signs measurements

    Heart monitoring (ECG)

    Laboratory tests

    Assessment of any side effects

  5. Step 5

    Final evaluation

    At week 24, final assessments will be conducted to measure:

    Changes in your cognitive function using a test called ADAS-Cog11

    Overall changes in your condition using CIBIC+

    Your ability to perform daily activities

    Any behavioral symptoms

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, attention, and ability to complete basic tasks)
  • 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 ensure medications are taken correctly
    • Will assist with study procedures
    • 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 serious adverse reactions (harmful or unwanted effects) to similar medications
  • Presence of other significant medical conditions that could interfere with the study, such as:
    • Uncontrolled high blood pressure
    • Unstable heart disease
    • Severe liver or kidney problems
    • Current participation in other clinical trials or use of experimental medications
    • Inability to follow study procedures or attend scheduled visits
    • History of substance abuse within the past year
    • Severe psychiatric conditions besides Alzheimer's Disease
    • Use of medications that could interact with the study drug
    • Recent changes in medications for treating Alzheimer's Disease
    • Significant changes in health status within the last 3 months
    • Conditions that would make it difficult to complete cognitive tests
    • Legal incapacity or limited legal capacity to provide informed consent
    • Pregnancy, breastfeeding, or planning to become pregnant during the study period
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • KarXT

    is an investigational medication designed to help improve thinking abilities and overall functioning in people with 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 used in combination with KarXT. This combination therapy aims to enhance the treatment's effectiveness in addressing cognitive impairment and improving daily functioning in Alzheimer's disease patients.

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 currently undergoing Phase 3 clinical trials for the treatment of mild to moderate Alzheimer's Disease symptoms. The medication works by targeting specific neurotransmitter systems in the brain that are involved in cognitive function and memory processing. While its exact molecular mechanism is still being investigated in clinical trials, it is designed to potentially improve thinking skills and overall functioning in Alzheimer's patients.

  • KarX-EC

    A complementary investigational medication being studied in combination with KarXT for treating cognitive decline in Alzheimer's Disease. This oral formulation is specifically designed with extended-release characteristics (EC stands for extended-release coating) to optimize the therapeutic effects when used alongside KarXT. The combination therapy is being evaluated in the MINDSET 1 clinical trial to assess its efficacy in 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 the mild to moderate stages, people experience increasing problems with memory, planning, language, and spatial awareness. During these stages, individuals may have difficulty remembering recent events, following conversations, managing finances, or navigating familiar places. The disease causes changes in behavior and personality, making daily activities more challenging. The condition involves the abnormal buildup of specific proteins in the brain, leading to the death of brain cells and the disruption of important neural connections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520746-30-00Protocol codeCN012-0051Estimated enrolment629 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).