Study of trospium chloride and xanomeline tartrate (KarXT) in patients with psychosis associated with Alzheimer’s disease

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What is this study about?

This study focuses on psychosis that occurs in people with Alzheimer’s disease. Psychosis involves experiencing things that are not real, such as seeing or hearing things that others do not (hallucinations) or having false beliefs (delusions). The study will test a medication called KarXT, which contains two active substances: trospium chloride and xanomeline tartrate. The purpose is to determine if KarXT can help reduce psychotic symptoms in people who have Alzheimer’s disease.

During the study, participants will receive either KarXT capsules or placebo capsules to take by mouth. The medication or placebo will be given over a period of several weeks to determine if KarXT helps improve the psychotic symptoms that can occur with Alzheimer’s disease. The study will compare how well KarXT works compared to the placebo in reducing these symptoms.

Before joining the study, participants will need to have brain imaging done using either magnetic resonance imaging (MRI) or computed tomography (CT) to confirm their diagnosis. Throughout the study, doctors will monitor the participants’ symptoms and overall health to evaluate how well the treatment is working and ensure their safety.

1 Initial assessment and medication start

You will begin taking KarXT or placebo (inactive substance) capsules orally. The assignment to either medication group is random.

Your psychosis symptoms associated with Alzheimer’s Disease will be evaluated using specific assessment tools.

2 Treatment period

You will continue taking the oral capsules throughout the study period.

The medication contains a combination of two substances: trospium chloride and xanomeline tartrate.

Regular evaluations will track changes in your hallucinations and delusions using a tool called NPI-C:H+D (a standardized assessment of mental health symptoms).

Your overall condition will be monitored using a scale called CGI-S (a measure of symptom severity).

3 Final evaluation

At the end of the treatment period, your symptoms will be assessed one final time.

The changes in your condition from the beginning to the end of treatment will be measured.

The study is expected to conclude by February 27, 2026.

Who Can Join the Study?

  • Must be between 55 and 90 years old
  • Must have a confirmed diagnosis of Alzheimer’s Disease according to the 2024 National Institute on Aging – Alzheimer’s Association criteria with biomarker confirmation
  • Must have had a brain scan (either MRI or CT) within the past 5 years since dementia onset to rule out other brain conditions (such as stroke, tumors, or bleeding under the skull)
  • Must have experienced psychotic symptoms (such as hallucinations or delusions) for at least 2 months before the initial screening visit
  • Both men and women can participate in the study
  • The brain scan must have been done after dementia symptoms started
  • Must be able to undergo required medical tests and evaluations during the study

Who Cannot Join the Study?

  • History of schizophrenia or other psychotic disorders not related to Alzheimer’s Disease
  • Current use of antipsychotic medications (medications used to treat psychosis symptoms)
  • Severe or unstable medical conditions that could interfere with study participation
  • History of seizures within the past year
  • Significant heart problems or abnormal heart rhythm
  • Active substance abuse or dependence within the past 6 months
  • Previous participation in clinical trials involving investigational drugs within 30 days
  • Severe kidney or liver problems
  • Unable to comply with study procedures or visits
  • Current thoughts of self-harm or history of suicide attempts in the past 6 months
  • Taking medications that could interact with the study drug
  • Presence of other neurological disorders besides Alzheimer’s Disease
  • Inability to provide informed consent (either directly or through a legal representative)

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
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Universitario Rio Hortega Valladolid Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
University General Hospital Of Heraklion Heraklion Greece
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
University Multiprofessional Hospital For Active Treatment Kanev AD Ruse Bulgaria
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
Henry Dunant Hospital Center Athens Greece
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
CNS Saude Lda. Torres Vedras Portugal
Hospital Victoria Eugenia De La Cruz Roja Espanola Sevilla Spain
Hospital Quironsalud Malaga Malaga Spain
Hospital Universitari De Santa Maria Lleida Spain
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
KBC Zagreb Zagreb Croatia
Eszak-Budai Szent Janos Centrumkorhaz Budapest Hungary
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Anima Alken Belgium
Provincia Lombardo Veneta Dell’ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli Brescia Italy
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Spitalul Clinic Cai Ferate Constanta Constanta Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Vrije Universiteit Brussel Jette Belgium
Epamed s.r.o. Kosice Slovakia
Medical Center Intermedica Ltd. Sofia Bulgaria
Clinic for psychiatry Sveti Ivan Zagreb Croatia
Klinika za psihijatriju Vrapce Zagreb Croatia
Neuro Centrum Science GmbH Erbach Germany
Mozcwxz Cxqikt Mxkvpk 2frr Eiqa Sofia Bulgaria
Pow Swpvl Sbe z oozd sesvt Lodz Poland
Ondhjea Bfgip Kcxmjpduwuc Bw Rhhwzbpw Sss z oppu Ilawa Poland
Cdzry Dtof Ssgbar Sibiu Romania
Cmj Dtx Bvruf Roqmyqn Etqnk Dcijzqz &ccvast Canuyqd Mdvnvej di Pamroknzk Oradea Romania
Mtkoq Bmiyf Dpukrctq nidmpsibwpct aegtigykip swveat Banska Bystrica Slovakia
Pczzjpouyx Kqtl Pecs Hungary
Ijgtwnsbtc Pzzvka dq Ceuaqgzsy Moaromalyql pfpfjd Bejv Awalwrdvch Egwcuwzjs sl Rjff Craiova Romania
Chbcxs Hgxqjmobpbh Rzuxubny Uwecrvfteifna Dz Tcymy Tours France
Gmgsix Urismitxzc Fyfvzkaow Frankfurt Germany
Ulkgairhemekjc Czugzxx Kfgydqcan Gdansk Poland
Uyxfniujhe Dczrl Smmmm Dl Raaa Ls Sjweuica Rome Italy
Kqhywuruz sdffvt Dubnica nad Váhom Slovakia
Upfqkxbepn Gkxjawb Hswqceed Atpiojb Athens Greece
Izznz Ofgkcyho Aoafqiqlhx Svs Lhtx Milan Italy

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.03.2025
Bulgaria Bulgaria
Recruiting
31.03.2025
Croatia Croatia
Recruiting
31.03.2025
France France
Recruiting
31.03.2025
Germany Germany
Not recruiting
31.03.2025
Greece Greece
Recruiting
31.03.2025
Hungary Hungary
Recruiting
31.03.2025
Italy Italy
Recruiting
31.03.2025
Poland Poland
Recruiting
31.03.2025
Portugal Portugal
Recruiting
31.03.2025
Romania Romania
Recruiting
31.03.2025
Slovakia Slovakia
Recruiting
31.03.2025
Spain Spain
Recruiting
31.03.2025

Trial locations

KarXT is an investigational medication being studied for treating psychosis symptoms (such as hallucinations and delusions) in people with Alzheimer’s disease. It is designed to help reduce psychiatric symptoms that can occur in Alzheimer’s patients without causing some of the common side effects associated with current antipsychotic medications.

The trial also includes a placebo, which is an inactive substance used to compare the effects of the actual medication.

Investigated diseases:

Psychosis Associated with Alzheimer’s Disease – A condition that occurs in some people with Alzheimer’s disease where patients experience hallucinations and delusions. Hallucinations involve seeing, hearing, or feeling things that are not actually present, while delusions are false beliefs that persist despite evidence to the contrary. This condition typically develops as Alzheimer’s disease progresses, causing significant changes in perception and thought processes. The symptoms can include seeing nonexistent people or objects, hearing voices, or having persistent unfounded suspicions about family members or caregivers. These psychotic symptoms can fluctuate in intensity over time and may become more pronounced in the later afternoon or evening.

Trial ID:
2024-516363-92-00
Protocol code:
CN0120056
NCT ID:
NCT06585787
Trial Phase:
Therapeutic confirmatory (Phase III)

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