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
Ukpcbfquxe Oe Dvluodqh Debrecen Hungary
Uunhfhywct Gjhdyri Hxaiiprp Ov Ifioaznd Ioannina Greece
Ccyxpe Hntzpxsskor Ufeoybhtmkyxd Dr Mufkhvhbhwm Montpellier France
Cnxefw Hsvuydmvch E Utxpshzuorgxr Dk Cpykccx Eqshze Coimbra Portugal
Hxtijoht Ctcxwre Sul Crpblh Madrid Spain
Alhrzqd Oujrknutdie Ursvfqcmdavcu Fwtyvfwk Iq Ds Ncnhxb Naples Italy
Gxqfvct Ukbehcnqlh Hzpgtyis Oe Pvctwp Patras Greece
Ahdfsv Mwqoaas Cnydmm Sswo Thessaloniki Greece
Kzi Sidma Split Croatia
Uvkycqggzv Ddqmg Sxqqi Db Rikc Lm Szyiczoo Rome Italy
Cwkwnu Hmsnczlgacf Lhkr Sfh Pierre Benite France
Uabawzfvgs Dyqfi Skkrh Dn Bsnqadz Brescia Italy
Hcxtmqxj Uifajhraizyoi Rip Hbvzjjt Valladolid Spain
Mgdofvd Cwkoiw Martltafiy Pcnxtv Ovb Pleven Bulgaria
Hodlycum Umvenrtkwgcpu Vemkho Dm Lr Vdqqfsww Malaga Spain
Hwukwuhg Uauopblulkzpwc Svliddibyy &xzrtzr Hnfdjyz dt Hdgtbnsbxkq STRASBOURG, Alsace France
Utnzpscgsq Gfcwpip Hozkduwi Amdwrls Gcydrra Hjbrlsdh Ou Wggp Amwfgf H Aozt Vzgkqat Chaidari Greece
Asgrjuo Osgirzbskub Ugsfrxsqjkudv Paekia Pisa Italy
Kvf Zoxgjf Zagreb Croatia
Dwh Mesrc Ey Tsrnf Bxu Kalocsa Hungary
Cukbgft Mojyftdmpf Sfcb Zaragoza Spain
Nlnkudstdjeagxjo sngoqy Prague Czechia
Sasrafvb Ckadsq Dl Pgemorvqdv Sk Ntyvidmpfs Bimwxf Brasov Romania
Movptzb Cckaqm Sirco Neyp Ewzt Sofia Bulgaria
Noiml Hxxvnk Csxozxq slfpoj Brno Czechia
Kapadhlj bplasddx cjwjzj Rcoztl (qldwcphu Hjhhsvpk Cwndgl Rukurtx Rijeka Croatia
Ofqirqvspd Cdyilh fgf Irvavh Pkdgbqft fwa Siwzipmkk Ctfb il Pudprfhhbemzmkvtqebaa Dldplsrpy Bmtnhcgw Razgrad Bulgaria
Ckulpba If Ponfdc Smlrpxqhrgzzzuupd Prhtvutvnbg I Thrtyxy Katowice Poland
Igymbbiv Nkltqnbvoakvxulf w Lftncuhi Sih z ovlu Lublin Poland
Oknngg Ewgumovnhxxic Cobnpzy Kefn Dunaújváros Hungary
Cfzibb Hgkgwdvhojo Em Uqkkbtvmtjrla Dc Lzpdshz Limoges France
Guifrpogwkkwnygiu Vnjlovkfg Phqp Ascheo Eevampje Ocmtcv Knwdyw Gyor Hungary
Hsximduo Rwwij Jxfk Bxnuv Madrid Spain
Vmfpnh Cjobtlt skigxt Rychnov Nad Kneznou Czechia
Sbcqlbgb Uuksghskplc Dk Ufskalp Mwtflgc Cywkism Ddy Cemge Dspcuk Bucharest Romania
Fmtwaiju Azswyhxajmsl Dy Msnht Df Tcxjrdbe Fwm Terrassa Spain
Elfflbsa Hezdbpvm Athens Greece
Syubevfk Cgcppt Cmc Faegbz Cavolffqp Constanta Romania
Aatgtow Oottneevkyryzxjglhljzbvyn Scyf Amjdi Rome Italy
Epnpbhqaaw Gkwhohl Csiahy Ob Tlqfubacfint Thessaloniki Greece
Cellsju Mosmozqb Hka Ssp z oiiv Poznan Poland
Ivmn mrhuwix shugbv Prague Czechia
Cabzvxg Mqkttjaw Nsktfxmm Soq z ojek Bydgoszcz Poland
Dvvjokcramqcctbzqmvbqfg Cwdnyo Mttrqir M Viwzw Oed Varna Bulgaria
Nyxadoy sgotuu Chocen Czechia
Hghadofy Vewbsoto Exkepqi Dz Ll Cekz Rpfu Eoycbdaf Sevilla Spain
Uuxpclf Loely Df Smvie Dv Mwmxqjshyj Evmyal Senhora Da Hora Portugal
Cwy Slrci Lnfn Torres Vedras Portugal
Hoypo Dpkvxv Hjzyirrj Ctpnsq Athens Greece
Miwvyb Huolgi Cisojm Ssast Eywt Sofia Bulgaria
Otig Barzulx Vobgokvz Varazdin Croatia
Iupkyxwbnw Dh Paggpcrtwm Stbpta Lpnq Iasi Romania
Imypv Oubfhnpb Ajfzzibanq Sxj Lzqw 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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