A study testing xanomeline tartrate and trospium chloride for treating agitation in patients with Alzheimer’s disease

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What is this study about?

This study involves people who have Alzheimer’s disease and are experiencing agitation, which means they may have behaviors such as restlessness, aggression, or emotional distress that are related to their condition. The treatments being tested in this study are KarXT, which is a capsule containing two substances called xanomeline tartrate and trospium chloride, and KarX-EC, which is a capsule containing only xanomeline tartrate. Some people in the study will receive these medications while others will receive placebo. The medications are also known by their code names BMS-986510 for KarXT and BMS-986519 for KarX-EC.

The purpose of this study is to find out if KarXT combined with KarX-EC works better than placebo in reducing agitation in people with Alzheimer’s disease. During the study, the effectiveness of the treatment will be measured using a rating scale that tracks agitation behaviors, such as physical and verbal aggression, and how often these behaviors occur. Doctors will also assess the overall severity of agitation symptoms to see if there is improvement with the treatment.

People taking part in this study will need to have a caregiver who spends enough time with them each week to observe their symptoms and help them follow the study requirements. The caregiver will attend study visits and provide information about the person’s agitation and overall condition. The study will involve taking the study medication or placebo in capsule form by mouth over a period of time, with regular visits to monitor safety and measure changes in agitation symptoms.

1 Treatment assignment

You will be randomly assigned to receive either the study medication or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active treatment.

The study medication is called KarXT, which contains xanomeline tartrate, combined with KarX-EC, which contains trospium chloride and xanomeline tartrate.

This is a double-blind study, which means neither you nor your doctor will know whether you are receiving the active medication or placebo during the treatment period.

2 Taking the study medication

You will take the assigned medication by mouth in the form of capsules.

Your caregiver will help ensure that you take the medication as prescribed and will monitor your compliance with the medication schedule.

The exact dosage, frequency, and duration of treatment will be determined by the study doctor based on the study protocol.

3 Regular study visits

You will attend regular visits at the study site throughout the treatment period.

Your caregiver must accompany you to all visits to provide information about your condition and behavior.

During these visits, the study team will assess your agitation symptoms using standardized questionnaires and scales.

4 Agitation assessments

Your agitation symptoms will be measured using the CMAI-IPA scale. This scale evaluates different types of agitated behaviors, including physical and verbal aggression.

The study team will also use the CGI-S scale, which is a rating of the overall severity of your agitation symptoms.

Your caregiver will provide information about your behavior and any changes in your agitation symptoms since the previous visit.

5 Safety monitoring

Throughout the study, the medical team will monitor you for any side effects or adverse reactions to the medication.

You should report any new symptoms or changes in your health to the study team.

Your caregiver will also help monitor your condition and report any concerns to the study team.

6 End of treatment

At the end of the treatment period, you will have a final assessment to measure any changes in your agitation symptoms compared to the beginning of the study.

The study team will evaluate the effectiveness of the treatment by comparing your scores on the CMAI-IPA and CGI-S scales from the start to the end of treatment.

After completing the treatment phase, the study team will provide information about any follow-up procedures or next steps.

Who Can Join the Study?

To join this clinical trial, patients must meet all of the following requirements:

Have a diagnosis of Alzheimer’s disease, which is a brain condition that affects memory and thinking, confirmed by one of these special tests: a brain scan called amyloid PET, or blood or spinal fluid tests that look for specific proteins related to Alzheimer’s disease
Score between 5 and 22 on the Mini-Mental State Examination, which is a test that measures memory and thinking abilities
Have one main caregiver who spends at least 10 hours per week with the patient and is willing to attend all study visits, help the patient take medications correctly, and answer questions about the patient’s behavior and symptoms
Have a history of agitation, which means showing behaviors like restlessness, pacing, or becoming upset easily, that started at least two weeks before joining the study
Score 4 or higher on a specific agitation rating scale at two different study visits, showing that agitation symptoms are present
Score 4 or higher on the Clinical Global Impression-Severity scale, which measures how severe the agitation symptoms are, at two different study visits
Show at least one of these patterns of aggressive behavior at two different study visits: one or more aggressive behaviors happening several times per week, two or more aggressive behaviors happening once or twice per week, or three or more aggressive behaviors happening less than once per week
Be an adult or elderly person, as the study includes participants from these age groups
Both male and female patients can participate in this study

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed information about which conditions or situations would prevent participation, it is not possible to list the specific reasons that would make someone ineligible for this clinical trial
Typically, exclusion criteria might include certain medical conditions, medications being taken, or other health factors, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
M2m Med. Sp. z o.o.	Chorzow	Poland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Centrum Medyczne Hcp Sp. z o.o.	Poznan	Poland
INEP medical s.r.o.	Prague	Czechia
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Neurohk s.r.o.	Chocen	Czechia
Hospices Civils de Lyon (HCL) – Hôpital des Charpennes	Villeurbanne	France
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Neuro Health Centrum s.r.o.	Brno	Czechia
AGE Centrum s.r.o.	Olomouc	Czechia
University Of Debrecen	Debrecen	Hungary
Clinexpert Kft.	Budapest	Hungary
A-Shine s.r.o.	Plzen	Czechia
Semmelweis University	Budapest	Hungary
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Vestra Clinics s.r.o.	Rychnov Nad Kneznou	Czechia
Gyongyosi Bugat Pal Korhaz	Gyongyos	Hungary
Universita Degli Studi Di Brescia	Brescia	Italy
Neuropsychiatrie s.r.o.	Prague	Czechia
University Of Strasbourg	STRASBOURG, Alsace	France
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Dzo Mvhmd Ei Taidq Btt	Kalocsa	Hungary
Huzujxn Fnqopsr Wagny	Paris	France
Csflhmo Ie Pugebs Szlyrywmgskogmzzs Prtunxsaaia I Tzwrznz	Katowice	Poland
Ckvdtl Hqmvcdrbclg Eq Uvvqrmufkirlc Dg Luuchxh	Limoges	France
Gjctaezlmnrznztwj Vhrwrlzqd Pspz Avtyfk Eqdhfpjl Oeriot Krrych	Gyor	Hungary
Umndcjujrs Dtszy Sosrm Dl Rkiq Ll Szouersa	Rome	Italy
Isqyc Okwzeaau Arehvqwlds Sec Lkom	Milan	Italy

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	26.11.2025
France	Recruiting	26.11.2025
Hungary	Recruiting	26.11.2025
Italy	Recruiting	26.11.2025
Poland	Recruiting	26.11.2025

Trial locations

Investigated drugs:

KarXT is an investigational medication being studied for the treatment of agitation in people with Alzheimer’s disease. This medication is being tested to see if it can help reduce agitation symptoms such as restlessness, aggression, or other behavioral problems that may occur in patients with Alzheimer’s disease.

KarX-EC is an investigational medication that is given together with KarXT in this study. It is designed to work alongside KarXT to help treat agitation associated with Alzheimer’s disease. The combination of these two medications is being evaluated to determine if it is safe and effective in reducing agitation symptoms in study participants.

Investigated diseases:

Dementia Alzheimer's type

Alzheimer’s Disease – Alzheimer’s disease is a progressive brain disorder that gradually destroys memory and thinking skills. The disease occurs when abnormal protein deposits form in the brain, causing nerve cells to die. As the condition advances, individuals experience increasing difficulty with daily activities and communication. Memory loss typically begins with forgetting recent events and conversations. Over time, confusion, disorientation, and changes in behavior become more pronounced. In some cases, individuals may develop agitation, which involves restlessness, irritability, and emotional distress.

Trial ID:

2025-520612-34-00

Protocol code:

CN012-0024

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study testing xanomeline tartrate and trospium chloride for treating agitation in patients with Alzheimer’s disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?