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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
KBC Zagreb Zagreb Croatia
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
INEP medical s.r.o. Prague Czechia
Neuro Health Centrum s.r.o. Brno Czechia
AGE Centrum s.r.o. Olomouc Czechia
Hospital Universitari De Santa Maria Lleida Spain
Hospital Victoria Eugenia De La Cruz Roja Espanola Sevilla Spain
General University Hospital Of Larissa Larissa Greece
A-Shine s.r.o. Plzen Czechia
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Clinical Medical Center Osijek Osijek Croatia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Eginitio Hospital Athens Greece
Universita Degli Studi Di Brescia Brescia Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Neuropsychiatrie s.r.o. Prague Czechia
Forbeli s.r.o. Prague Czechia
Institutul De Psihiatrie Socola Lasi Iasi Romania
Klinika za psihijatriju Vrapce Zagreb Croatia
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Bialystok Poland
Cisacrn Bhizi Kogaymoaiey Pxbgxuss Sxz z okfk Gdansk Poland
Kkmkqxal bdeokuiu cpfwmf Rztyom (tywvfomr Hxlahogm Cwsttb Rxlaatw Rijeka Croatia
Utopjhtnylzhujpomyarl Muorjcqd Azq Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Croatia Croatia
Recruiting
25.07.2025
Czechia Czechia
Recruiting
25.07.2025
Germany Germany
Recruiting
25.07.2025
Greece Greece
Recruiting
25.07.2025
Italy Italy
Recruiting
25.07.2025
Poland Poland
Recruiting
25.07.2025
Romania Romania
Recruiting
25.07.2025
Spain Spain
Recruiting
25.07.2025

Trial locations

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.

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 ID:
2025-520746-30-00
Protocol code:
CN012-0051
NCT ID:
NCT06976216
Trial Phase:
Therapeutic confirmatory (Phase III)

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