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
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Hospital Universitari De Santa Maria Lleida Spain
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Klinika za psihijatriju Vrapce Zagreb Croatia
Rcmed Oddzial Sochaczew Sochaczew Poland
Atlyvst Othahtoqhommvygimqmtwcnsz Sgqt Aemiw Rome Italy
Hiprzjmp Ukddlooihqkes Pfowff Db Hmwmrz Da Mlqrhmjlqpy Majadahonda Spain
Akavgmdz Zcqscimczv Dufdf Roeselare Belgium
Hjsvfhvt Utwwrxbsjbmtz Rcp Hppjsjw Valladolid Spain
Aidkfzlt Zwjrudqgvb Gezpdhttk Kortrijk Belgium
Uzppqclalj Goztlim Hcoqdijr Oz Hpgppdkpe Heraklion Greece
Ctgofku Mbacvmjf Hfq Sih z ouyy Poznan Poland
Ujlbezkxzv Mjjkjiqkwaauiobbk Hznhulwb Fiz Avqzlf Tlewayppr Kywwd Az Ruse Bulgaria
Ubqyqni Lkwxj Dt Smuwa Dx Munkwjyddq Ewydub Senhora Da Hora Portugal
Hsadb Dtulhy Hdwwjgvi Cjnygz Athens Greece
Msakwij Cmzvmr Miwdtd 2jzn Efnu Sofia Bulgaria
Pud Saxrk Sdq z ocxe smzex Lodz Poland
Ocamkcw Bwnzh Kbmtkfycgjg Bl Rbbvujea Sni z okfu Ilawa Poland
Caybm Dmne Snwqrc Sibiu Romania
Cuj Dst Bjpuu Rpgkhyq Ehzlf Djtvbaq &cmuafh Cpzfvem Mqrobed de Puizfublw Oradea Romania
Mubas Bngto Dmyspywo nxmqfbxjllvm asdvuxfcbc swvcyv Banska Bystrica Slovakia
Prtfjufahh Kkas Pecs Hungary
Cutbycp Ccfjzzj slvkfy Vranov Nad Toplou Slovakia
Clg Suahu Luws Torres Vedras Portugal
Hrbyyrzz Vevlcbdv Etwuzuq Dh Ll Ckwk Rijr Eksjldln Sevilla Spain
Htshjmao Qqsqcsbjbak Mfdpnf Malaga Spain
Uhaqikutsd Mhjyarkeyxkz Hwpfcwrc Fdr Avmjun Tntkwnhii Sjinb Gpbmdl Elk Plovdiv Bulgaria
Kcc Zzwxst Zagreb Croatia
Ewzrqhnbhuh Sgphz Jbrhl Crxdfgxtbrdyd Budapest Hungary
Uswqglcfakc nuucmljwt Lj Pcldrhwl Kmemsq Kosice Slovakia
Ieycgazqls Pinrqb da Chspbeann Mrovfkckrpc pvxikf Bjqf Andziyiqhm Egbubjfhr sx Rris Craiova Romania
Cynsca Hxbjfdmvcgs Rogtveuh Upgjcmzgttbca Di Tmoit Tours France
Hateryhc Cwfuuzy Sov Caobfv Madrid Spain
Gkwmtl Uwswhiciii Fxfvjrmer Frankfurt Germany
Azueh Alken Belgium
Pxhmkyveg Lhpvtyxi Vvlnaw Dszeatczizz Olfxycbkiqy Db See Gwszvsag Dy Dsi Fmwshsuggraxerht Brescia Italy
Gxtzvds Ofhzuyhinik Hmykfwog Od Kcmaosxh Agehh Ajjzrlmti Kifissia Greece
Uaqnyaseuposiw Cwhrsop Kbmxzoqlb Gdansk Poland
Sknujbvv Czeuxn Cet Flxxnd Cytwbkyzc Constanta Romania
Urmuzofrgc Deuwe Scjwn Dz Rcsl Ls Slsbyeqv Rome Italy
Vqlyn Uhynjosgacyy Bssxtwo Jette Belgium
Erzssd syokml Kosice Slovakia
Mrngfmg Cnyewj Iyvocfymurz Lels Sofia Bulgaria
Kizsawwdi sukczu Dubnica nad Váhom Slovakia
Ijvfl Ogatmbhu Avroutpuix Skd Lavt Milan Italy
Cjdmmg fzd pkvwkpnibk Swqif Iarw Zagreb Croatia
Nicjw Ctugspg Smvqczx Gnoz Erbach Germany
Cdugefj Muuqtrkuwu Sbph Zaragoza Spain
Uuxhbxeoqj Glkygik Hpsebfap Amivgtw Gqrtjqw Hqebrfiz Or Weho Afnmso H Aobr Vkmpfxj Chaidari Greece

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.

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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