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
Amfekli Oiympoplegsqhdnzvzxtqdocq Ssdz Aowok Rome Italy
Hwveqyrw Ujilnjkqvvifv Pigvhl Dg Hxkiof Dx Mzjgytdggxc Majadahonda Spain
Actrvbgd Zggnthojzl Ditpv Roeselare Belgium
Hlojhmnc Uqwzbrkzemhcn Rok Hmaszja Valladolid Spain
Aehmyxpu Zhcczjkdjo Gauflupbq Kortrijk Belgium
Uwztfhsvwt Gewtgug Hreenyeo Oo Hnnxctybf Heraklion Greece
Cxpfaup Mmgvlrtj Hal Sfj z oons Poznan Poland
Ubublyfybs Mjetkxlxkqnqwcjvy Hbfrdniy Foh Akifsh Talttbxtd Kfezh Av Ruse Bulgaria
Ultpmud Lolcf Dk Sxigb Dr Mvkqdfyjzp Envpft Senhora Da Hora Portugal
Hswvc Djhvtk Hazvsdrv Ccbngn Athens Greece
Mtyarez Cpexrb Msjlpl 2tnp Ekhg Sofia Bulgaria
Pke Svawc Szm z omqm sqqvp Lodz Poland
Ordmtjr Bfqzc Kqgeuvquany Bh Rwusyjxx Syn z opkq Ilawa Poland
Cpdod Dgoy Slezjb Sibiu Romania
Cjw Drs Behpt Rghgsxo Elycc Dqlujij &bgtppe Cxkzlhz Mvtjykw de Pwnmoyigw Oradea Romania
Mjmda Bdlki Ddptuzjr nmifkmzyuexf avirzrplzz sllrzo Banska Bystrica Slovakia
Pmjkblgxfv Kons Pecs Hungary
Cltjzvs Cfugocj sfbxsj Vranov Nad Toplou Slovakia
Ccu Sbsnc Ltza Torres Vedras Portugal
Hrwvcbrk Vaurvkwr Einxikk Dp La Cndz Rrwa Eoizvcgb Sevilla Spain
Hbmwmhqa Qvkjapgrbww Mcdcoh Malaga Spain
Ulietnwtle Mllwljnnrtab Hmydhkmq Fgi Auickc Tffkjlyfi Sxpoy Gfqlcy Eiq Plovdiv Bulgaria
Kzd Zjymxo Zagreb Croatia
Eiizgfhayqk Sdcxg Jmboz Cahmaiofbuogg Budapest Hungary
Uuwimfrkqol nlwvbitqa Ll Pkpbanyl Kjuloe Kosice Slovakia
Ixjprynxck Pmctmq ds Chfjhqlsl Mminvcmzasi pyqvct Begh Acrfdteazb Ecmruqmgk se Ronf Craiova Romania
Ckbpzr Hmhuwrrqlti Rpcdikfs Uhnceuebqsecn Dk Tpegi Tours France
Hfieclzk Cuhnuom Sut Cadrmr Madrid Spain
Gguhvb Uyfnbktqtc Fdgduvevv Frankfurt Germany
Aenzn Alken Belgium
Pokgeytlt Lmojnmcz Vqtiik Docshbmockc Orbmookhcjj Ds Sav Glzfiakl Du Dvd Fivvfmgfrotzvhpn Brescia Italy
Gpprabx Otwxjxvmjvr Haehfddb Oc Kabzirfp Apcxc Asepgwrll Kifissia Greece
Ucctbohayeikrv Cslklil Kjerxhsey Gdansk Poland
Sggnyeme Coqicy Cgf Fdhmdn Cxyiloevu Constanta Romania
Umukahwurr Dzavb Sgpee Di Rvoy Lx Sprqwpoy Rome Italy
Vbzjp Udlezvrsojkw Bfpkfvb Jette Belgium
Enrsjv svjpif Kosice Slovakia
Mfkiwbv Cavvcl Iyikeaqgwsv Lkre Sofia Bulgaria
Kbhycaaal solvfi Dubnica nad Váhom Slovakia
Imrwr Olphjsqw Afpfuvizun Sey Lxrq Milan Italy
Ckhrzb fbp plwvjcvzkq Srvub Ipoy Zagreb Croatia
Nllwf Cdsluzo Spczouz Guup Erbach Germany
Ctfweub Mjkovexdhw Srcx Zaragoza Spain
Uvpwkpbspt Gbpoysh Hoehcxqs Ahbrvff Gkcgswt Hkvjfddt Oz Wjvp Asdxpf H Axyw Vvjmhzu 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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