Study on Long-Term Safety of KarXT (Trospium Chloride, Xanomeline Tartrate) for Patients with Alzheimer’s-Related Psychosis

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What is this study about?

This clinical trial is focused on studying the long-term safety and how well people tolerate a medication called KarXT in individuals experiencing psychosis associated with Alzheimer’s disease. Psychosis in this context refers to symptoms like hallucinations or delusions that can occur in people with Alzheimer’s disease. The medication being tested, KarXT, is taken in capsule form and contains two active substances: trospium chloride and xanomeline tartrate. These substances are designed to work together to help manage symptoms of psychosis.

The purpose of this study is to understand how safe KarXT is when used over a long period and how well it is tolerated by participants. Participants in the study will take the medication orally, meaning by mouth, in capsule form. The study will last for up to 52 weeks, during which participants will be monitored for any side effects or changes in their condition. Some participants may receive a placebo, which is a capsule that looks like the medication but does not contain the active substances.

Throughout the study, researchers will keep track of any side effects, known as treatment-emergent adverse events (TEAEs), that participants experience. They will also monitor for any serious side effects or any that might lead to stopping the medication. This information will help determine the long-term safety and tolerability of KarXT for people with psychosis associated with Alzheimer’s disease. The study aims to provide valuable insights into the potential benefits and risks of using KarXT for this condition.

1 joining the study

Participation begins after completing a previous study, either KAR-031 or KAR-032.

Eligibility includes being between 55 and 90 years old at the time of enrollment in the previous study.

Understanding the study’s nature and requirements is necessary, and informed consent must be provided. If unable to consent, a legally acceptable representative or caregiver must do so.

2 medication administration

The medication used in the study is called KarXT, which is taken orally in the form of a capsule.

KarXT contains the active substances trospium chloride and xanomeline tartrate.

The dosage, frequency, and duration of administration are determined by the study protocol and will be communicated during the study.

3 monitoring and assessments

Regular visits are required to monitor the long-term safety and tolerability of KarXT.

A caregiver must attend all visits, oversee medication compliance, and participate in assessments.

The study aims to observe any side effects, known as treatment-emergent adverse events (TEAEs).

4 completion of the study

The study is estimated to end by June 30, 2026.

Participants will be informed about the study’s completion and any necessary follow-up actions.

Who Can Join the Study?

  • Must have completed study KAR-031 or KAR-032.
  • Must be between 55 to 90 years old at the time of joining the previous study (KAR-031 or KAR-032).
  • Must understand the study and agree to participate by signing a consent form. If unable to do so, a legal representative or caregiver must provide consent, and the participant must agree electronically or on paper.
  • If moving to a nursing home during the study, approval from the study’s Sponsor or Medical Monitor is required to continue participation.
  • Must be able to move around by themselves, with or without help from a device, and have a caregiver who spends about 10 hours a week with them. The caregiver must attend all visits, help with medication and study tasks, and agree to participate in the study.
  • Female participants must not be pregnant or breastfeeding. Women who can have children, or men whose partners can have children, must use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication. Sperm donation is not allowed for 30 days after the last dose. A woman is considered able to have children from her first period until she has not had a period for 12 months or has had surgery to prevent pregnancy.

Who Cannot Join the Study?

  • Patients who do not have psychosis related to Alzheimer’s Disease cannot participate. Psychosis means having trouble with reality, like seeing or hearing things that aren’t there.
  • Patients who are not in the specified age range cannot participate. The age range includes older adults.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is defined by certain characteristics needed for the study.
  • Both men and women can participate, but if a patient does not meet other criteria, they cannot join.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need extra protection in a study.

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
KBC Zagreb Zagreb Croatia
Centre Hospitalier Universitaire Rouen Rouen France
Medical Center Hera EOOD Sofia Bulgaria
Azienda Ospedaliero Universitaria Di Modena Modena 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
Silmedic Sp. z o.o. Katowice Poland
Clinical Medical Research Sp. z o.o. Katowice 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
Athens Naval Hospital Athens Greece
Complejo Asistencial De Zamora Hospital Provincial De Zamora Zamora Spain
Henry Dunant Hospital Center Athens Greece
Medical Center Saint Naum EOOD Sofia Bulgaria
CNS Saude Lda. Torres Vedras Portugal
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
Hospital Victoria Eugenia De La Cruz Roja Espanola Sevilla Spain
Hospital Quironsalud Malaga Malaga Spain
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Eszak-Budai Szent Janos Centrumkorhaz Budapest Hungary
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
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
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Vrije Universiteit Brussel Jette Belgium
Clintrial s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Saarland University Hospital Homburg Germany
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
University Of Szeged Szeged Hungary
Epamed s.r.o. Kosice Slovakia
Medical Center Intermedica Ltd. Sofia Bulgaria
Clinoxus s.r.o. Prague Czechia
Hospital Maison Blanche Reims France
Clinic for psychiatry Sveti Ivan Zagreb Croatia
Klinika za psihijatriju Vrapce Zagreb Croatia
Neuro Centrum Science GmbH Erbach Germany
Nwefepvnhuct Ky sssdht Prague Czechia
Mcmuk Bpapx Dduauncl nnhxnnnfcnha awgjjyzdtt sxbrjv Banska Bystrica Slovakia
Puzuatnbfw Ktyc Pecs Hungary
Mwdehyo Ccopxy Mesigb 2eci Epuz Sofia Bulgaria
Cwrwa Dodz Sekiqf Sibiu Romania
Pbc Sweax Sjh z oyxy sbngy Lodz Poland
Olemubw Bayesbfs Nonynxf Dugaiwtsbmb Cmwrnd Oltmdmoerfr Izh Kwgnutt Hdizixm Kqmtaybww Gumvjpbwkfsp Oezvzdq Avhooaiebxbyjq Sqm z ookh Scinawa Poland
Prsogyahwny Seltkoqzinj Snl z ovar Bydgoszcz Poland
Mtjmowhr Mdirslqz Svk z oihg Lodz Poland
Oakzwhg Bnart Kgvdgfagiiu Bi Rhcjzpqa Svm z owpq Ilawa Poland
Ctocdr Hxgekoaqjss Rqjlgiwz Uwbqlhsqrzkyi Dj Tsfbd Tours France
Gqhajg Uylukapghn Fkqqfndjp Frankfurt Germany
Umgbfpznyouapd Cyyfmju Klkysfcyr Gdansk Poland
Ittuxgazvl Ptduox dp Cuiiodqvr Moyfmfxlstl pjmyim Bxnu Avlywxacgg Egwmthajc sr Rzht Craiova Romania
Umgdelyofo Dnrbd Suhcx Dh Rpwp Lk Soxklxcc Rome Italy
Hmmaug Dypkqabaqc aub Tpxhnnjmzit Cqwefz oy Amvbqz Athens Greece
Cne Dlx Bplgk Rhrtwhl Efchk Dfqbllx &yelwkz Ciffcyw Mjfkasa du Ptyapyyxx Oradea Romania
Mbmfnsn Cihtrz Mfybjcocti Pvisjw Otj Pleven Bulgaria
Sspoubzbhsuxyi Duq Brikqiv Gvdo Böblingen Germany
Kdrqolhck spfjsf Dubnica nad Váhom Slovakia
Uujgeervul Gixqzpm Hjwkimez Acwohbh Athens Greece
Inajl Otqgyiyt Agpnlhdfrt Sot Lrhx 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
01.03.2024
Bulgaria Bulgaria
Recruiting
01.03.2024
Croatia Croatia
Recruiting
01.03.2024
Czechia Czechia
Recruiting
01.03.2024
France France
Recruiting
01.03.2024
Germany Germany
Not recruiting
01.03.2024
Greece Greece
Not yet recruiting
01.03.2024
Hungary Hungary
Not yet recruiting
01.03.2024
Italy Italy
Recruiting
01.03.2024
Poland Poland
Recruiting
01.03.2024
Portugal Portugal
Not yet recruiting
01.03.2024
Romania Romania
Recruiting
01.03.2024
Slovakia Slovakia
Recruiting
01.03.2024
Spain Spain
Recruiting
01.03.2024

Trial locations

KarXT is a medication being studied for its potential to help people with psychosis related to Alzheimer’s Disease. The trial aims to understand how safe and tolerable this medication is when used over a long period. KarXT is designed to target specific symptoms of psychosis, which can include hallucinations or delusions, and may help improve the quality of life for those affected by these symptoms.

Investigated diseases:

Psychosis associated with Alzheimer’s Disease – This condition involves experiencing symptoms of psychosis, such as hallucinations or delusions, in individuals diagnosed with Alzheimer’s Disease. Alzheimer’s Disease is a progressive neurological disorder that leads to memory loss and cognitive decline. As the disease advances, some individuals may develop psychotic symptoms, which can include seeing or hearing things that are not present or holding false beliefs. These symptoms can vary in intensity and may fluctuate over time. The presence of psychosis can complicate the management of Alzheimer’s Disease, affecting the individual’s behavior and interactions. Understanding and addressing these symptoms is crucial for improving the quality of life for those affected.

Trial ID:
2023-504151-27-00
Protocol code:
KAR-033
NCT ID:
NCT05980949
Trial Phase:
Therapeutic confirmatory (Phase III)

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