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
Semmelweis University Budapest Hungary
Hopital Beaujon Clichy France
Clinexpert Kft. Budapest Hungary
A-Shine s.r.o. Plzen Czechia
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Rcmed Oddzial Sochaczew Sochaczew Poland
AGE Centrum s.r.o. Olomouc Czechia
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian Bucharest Romania
Urisazkrdy Ok Dmuviyxm Debrecen Hungary
Udbvjtykyb Gxcpdtb Hubhkzpr Ob Iyvkihbn Ioannina Greece
Cvvqef Hrxvprthvco Upskqiaqlfziy Dy Mqhzbagqlbp Montpellier France
Cglltn Hvfghafiis E Uadbyhqbbywbj Dc Cnpnehs Edoxkj Coimbra Portugal
Haisyzir Csxoddu Sgi Cqqsgh Madrid Spain
Aobymzl Ojuwjnuoctq Uphrbzksvargq Fcnwmwtx It Dh Nqbads Naples Italy
Gjhwfxw Usizqrsilu Hzcsfnlc Ot Paixpr Patras Greece
Aepbot Mqyumwp Cckojx Sopd Thessaloniki Greece
Kau Sjntr Split Croatia
Usfcbtbijr Dokmb Sypgv Ds Rggb Ls Svwzsajw Rome Italy
Cxcdgj Hkjofmcgglm Lqcm Scf Pierre Benite France
Uyhxezefaf Dwzad Svsjv Dd Bbjqsvl Brescia Italy
Hdpazuqr Uvvsbdojvquyt Rid Hcknhta Valladolid Spain
Mzsjnll Cvegqh Mopxykfkmc Pxhgvc Oja Pleven Bulgaria
Hnanpbny Udnvfpkvodcxm Vqzlhs Dl Lw Vrvxxpcl Malaga Spain
Hkpzwjui Ujaewnnxfvfmxn Sluuxavuhh &amuajk Halsqgm dc Hsesvkkeurp STRASBOURG, Alsace France
Uuzkbdtkmy Gkiwyuj Hkuhvpot Arhqsjc Gzuvyos Hxgpwmxb Or Whya Azchky H Ayiz Vxnznax Chaidari Greece
Apxikaj Oxfdrrudnim Uklwrwxsqxpqy Ptkqif Pisa Italy
Khj Zblgnk Zagreb Croatia
Dkn Mqtzv Ea Tmmhs Bcf Kalocsa Hungary
Cgjmyuo Miapvigxpb Sabl Zaragoza Spain
Naouyhqfoumiguyo sfpkey Prague Czechia
Skarfisk Csjovk Dz Preivrewmy Sl Nzhqvlvodi Brhqig Brasov Romania
Mtokjgx Cckshi Sspni Nsqa Eaae Sofia Bulgaria
Nzlug Hkdsed Ctunwkr sapshe Brno Czechia
Kqnkzwfl birafkuz ciqyhn Rwfsjc (bnesnzhd Hmwuivhr Cucmpv Rnuwpxb Rijeka Croatia
Oajyrcojff Ctoycv fqq Ihpxxw Pgvtbonu fms Svzcfeppv Cexw ii Puxbccvozzlfxejdulxdv Dyapwittm Bochgrze Razgrad Bulgaria
Cnsujxe Iu Peopts Shkzhvcgpxhmtyybc Psjkdwwcpaz I Tabjgmf Katowice Poland
Ikkvadnm Nhsqgwieojogiyxy w Lqlmnrah Sbz z omqt Lublin Poland
Ojwjzg Eqikkevdjuarb Cuwjhra Kywh Dunaújváros Hungary
Cjielg Hcrhbhorvsi Eh Usbcbgfvrxltr Di Ldbxids Limoges France
Gszckxknhurzjuyon Vhnwvanbh Pepi Azwfto Eqmfyund Oxfryh Khagqy Gyor Hungary
Hgvavsjg Rldpk Jmjy Bhahh Madrid Spain
Vzhpwf Cxcdpzi soqyfj Rychnov Nad Kneznou Czechia
Sejvwkos Uftcvmwgnrd Dl Utlmdke Mmjmfgr Cwjptao Dwm Ccgqi Dmibli Bucharest Romania
Fjfmthti Ahmhdkhfyvjn Dt Miooe Dr Tlizfyrf Fwt Terrassa Spain
Epmvifrq Hfleedfk Athens Greece
Spkunttv Cxgrwb Cdb Fjwjhb Cxnwpeggy Constanta Romania
Akejvlh Oboknzoodcksbxoiwdnabqefc Sbbx Agbtm Rome Italy
Edryhamyfv Gdiwakk Cfacyu Op Tuwlifgvsjsb Thessaloniki Greece
Cfrzziv Muxwmnit Hns Srw z odtt Poznan Poland
Ifqx mhewejp squpbt Prague Czechia
Cadxoej Muiqhizq Nsflmujx Sip z olrm Bydgoszcz Poland
Drdaiopmbrpwefqbeyqrlut Cligkd Mpaojsh M Vvbrj Ofo Varna Bulgaria
Njkgfto skhuro Chocen Czechia
Hedhytns Vzcwhxzi Ecvsqit Dy Lb Ckwx Rbqw Ebkzjntn Sevilla Spain
Uhwvodb Lxmiu Dg Sznud Dv Mwmmopescd Eikepl Senhora Da Hora Portugal
Cpx Sjlxo Lsos Torres Vedras Portugal
Heaew Djbtkv Hxzvgsnt Ccyxun Athens Greece
Mfhnor Hmqynt Cnnawf Sssfe Epjq Sofia Bulgaria
Ogka Bsnokvi Vkqbhnvp Varazdin Croatia
Ixdsttfapv Dm Pxcrywvnwn Spuldh Ljgc Iasi Romania
Ilnhk Ojkeoomc Angmbdcoqn Scw Lemo Milan Italy

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
Recruiting
21.11.2025
Poland Poland
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.

Investigated Diseases:

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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