Study of trospium chloride and xanomeline tartrate combination for agitation in Alzheimer’s disease patients: Long-term safety evaluation

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What is this study about?

This study focuses on testing medications called KarXT and KarX-EC in people who have Alzheimer’s Disease with agitation – a condition where patients show signs of restlessness, emotional distress, and aggressive behavior. The purpose is to evaluate how safe these medications are and how well patients tolerate them when used for a long period.

The medications being tested contain active substances called trospium chloride and xanomeline tartrate. They come in the form of capsules that are taken by mouth. The study will involve patients who have previously participated in related research studies of these medications.

During the study, researchers will monitor various aspects of participants’ health, including any side effects, changes in body weight, blood pressure, heart rate, and mental function. They will also check for any unusual movements, restlessness, and other health-related factors to ensure the medications’ safety over extended use.

1 Initial qualification

To participate in this study, you must have completed either study CN0120023 or CN0120024

You will need to sign a new informed consent form

You must have a caregiver who can accompany you to all study visits, ensure medication compliance, and participate in behavioral assessments (approximately 10 hours per week)

2 Medication administration

You will receive oral capsules of KarXT and KarX-EC

These medications contain active substances: trospium chloride and xanomeline tartrate

The medication will be taken by mouth according to the prescribed schedule

3 Regular monitoring

Your health will be monitored through regular assessments including:

Blood pressure and heart rate measurements

Body weight checks

Laboratory blood tests

Evaluation of any unusual body movements or restlessness

Assessment of cognitive function

Monitoring of urinary function

Mental health status checks

4 Safety monitoring

Any side effects or health changes will be recorded and monitored

The study team will track any adverse events that may occur during treatment

Special attention will be paid to specific health concerns related to the medication

5 Study duration

The study begins in November 2025

The estimated completion date is July 2029

Your participation will help evaluate the long-term safety of the medication for treating agitation in Alzheimer’s Disease

Who Can Join the Study?

  • Must have completed participation in either study CN0120023 or CN0120024
  • Must be able to sign a new informed consent form showing agreement to participate in the study
  • Must have a dedicated caregiver who can:
    • Accompany the participant to all study visits
    • Ensure medication is taken as prescribed
    • Help follow study procedures
    • Participate in interviews about participant’s behavior
    • Dedicate approximately 10 hours per week or more to these tasks
  • Both men and women can participate in the study
  • Must be an adult (age ranges included in the study are adults and elderly)
  • Must be capable of following study procedures and requirements
  • Must be willing to participate in interviews and complete questionnaires about behavior changes

Who Cannot Join the Study?

  • History of severe allergic reactions to medications similar to those used in the study
  • Current participation in other clinical trials or within 30 days before this study
  • Significant heart conditions or abnormal heart rhythm (diagnosed through ECG)
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • History of major psychiatric disorders other than Alzheimer’s-related agitation
  • Current use of medications that could interact with the study drug
  • Presence of any medical condition that could interfere with the study results
  • Unable to comply with study procedures or follow-up visits
  • Substance abuse or alcohol dependency within the past year
  • Any unstable medical condition that requires immediate treatment
  • History of seizures or other neurological conditions besides Alzheimer’s
  • Participation in an experimental drug trial within the last 3 months

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
University Of Debrecen Debrecen Hungary
Clinexpert Kft. Budapest Hungary
A-Shine s.r.o. Plzen Czechia
Neuropsychiatrie s.r.o. Prague Czechia
University General Hospital Of Ioannina Ioannina Greece
Spitalul Clinic De Psihiatrie Si Neurologie Brasov Brasov Romania
Medical Center Saint Naum EOOD Sofia Bulgaria
Neuro Health Centrum s.r.o. Brno Czechia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Montpellier Montpellier France
General University Hospital Of Patras Patras Greece
Hospital Ruber Juan Bravo Madrid Spain
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Eginitio Hospital Athens Greece
KBC Split Split Croatia
Spitalul Clinic Cai Ferate Constanta Constanta Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Hospital Universitario Rio Hortega Valladolid Spain
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
AGE Centrum s.r.o. Olomouc Czechia
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Neurohk s.r.o. Chocen Czechia
Hospital Victoria Eugenia De La Cruz Roja Espanola Sevilla Spain
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
CNS Saude Lda. Torres Vedras Portugal
Henry Dunant Hospital Center Athens Greece
Opca Bolnica Varazdin Varazdin Croatia
Institutul De Psihiatrie Socola Lasi Iasi Romania
Hospital Universitario Virgen De La Victoria Malaga Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian Bucharest Romania
Ddm Mldbg Ev Tidhv Brv Kalocsa Hungary
Krdjdojr buoglojz cdabzh Raxjmy (dhqsqgjv Hmrtfphy Cfxbbg Rthadtn Rijeka Croatia
Ofkbafrbsi Cunhmq fwx Imcnpe Pxhpqiid fpb Suwfenscq Cthr ib Pcwdrddgstfuqxcxsqlqe Deejuhszd Bzkpwfoh Razgrad Bulgaria
Cxxexpm Ik Pvzqot Srhpwchubjewifkxf Pkibhfowqmo I Twuafif Katowice Poland
Ihjogjxw Ndgrnytrehehicak w Lkjthcoj Sas z olyy Lublin Poland
Ctyecs Hxchpwbxicq Ef Uuvvzmkaryxtn Dz Lgwncrb Limoges France
Gqywhnjexopwsytiq Vmnbylugf Pdsl Aykcmd Eflqurkj Orfham Kxmeje Gyor Hungary
Aircyq Mdpthvv Cbpzrr Sqog Thessaloniki Greece
Unkdfzyyuc Dlzvx Sbagk Db Rnlj Ly Swmlpcsc Rome Italy
Miyqbp Hgisnd Cjnvqm Sakwi Eldd Sofia Bulgaria
Murvvmb Cjzprk Mpviaytwmn Pwcfwc Ooh Pleven Bulgaria
Ixpgf Ogqghyff Axwybxdquu Sgx Lpvm Milan Italy
Hoskqksm Urdrebgdaghfgk Saeddcpwgc &krlzox Hngygpk dj Hmkyscekyyc STRASBOURG, Alsace France
Cbakzo Hoowlzrdyl E Ucrrgonqlpkui Dq Cjuteul Enxbvt Coimbra Portugal

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
21.11.2025
Croatia Croatia
Not yet recruiting
21.11.2025
Czechia Czechia
Not yet recruiting
21.11.2025
France France
Not yet recruiting
21.11.2025
Greece Greece
Not yet recruiting
21.11.2025
Hungary Hungary
Not yet recruiting
21.11.2025
Italy Italy
Not yet recruiting
21.11.2025
Poland Poland
Not yet recruiting
21.11.2025
Portugal Portugal
Not yet recruiting
21.11.2025
Romania Romania
Not yet recruiting
21.11.2025
Spain Spain
Recruiting
21.11.2025

Trial locations

KarXT is an investigational medication being studied for treating agitation in people with Alzheimer’s disease. It works by targeting specific brain receptors that may help control agitated behaviors and symptoms that are common in Alzheimer’s patients.

KarX-EC is a supplementary medication used in combination with KarXT. It is being studied to understand how well these medications work together for long-term treatment of agitation symptoms in people with Alzheimer’s disease.

Agitation Associated with Alzheimer’s Disease – A behavioral symptom that commonly occurs in people who have Alzheimer’s disease, characterized by excessive psychomotor activity, emotional lability, and a heightened state of arousal. Patients may display restlessness, pacing, verbal aggression, and physical aggression. The condition tends to fluctuate throughout the day and often worsens in the late afternoon or evening. It typically develops as Alzheimer’s disease progresses and can significantly impact daily activities and social interactions. The agitation may be triggered by environmental changes, confusion, or inability to communicate effectively.

Alzheimer’s Disease – A progressive brain disorder that slowly destroys memory, thinking skills, and the ability to carry out simple tasks. The disease begins with mild memory loss and confusion, gradually affecting various cognitive functions. Brain changes typically start years before the first symptoms appear. As the disease advances, individuals experience increasing difficulty with communication, reasoning, and judgment. The condition affects different parts of the brain, leading to various cognitive and behavioral changes over time.

Trial ID:
2024-519994-20-00
Protocol code:
CN012-0025
NCT ID:
NCT06937229
Trial Phase:
Therapeutic confirmatory (Phase III)

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