Clinical trial • Phase III • Psychiatry
trospium chloride, xanomeline tartrate for Agitation associated with Alzheimer's disease
Phase III trial of trospium chloride, xanomeline tartrate for Agitation associated with Alzheimer's disease.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Agitation associated with Alzheimer's disease
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-06-2025
- First CTIS Authorization Date
- 22-10-2025
Trial design
Randomised, placebo (karxt matching placebo and karx-ec matching placebo); dose/schedule not specified in the available record.-controlled Phase III trial across 34 sites in Italy, France, Hungary and others.
- Randomised
- Yes
- Comparator
- Placebo (KarXT matching placebo and KarX-EC matching Placebo); dose/schedule not specified in the available record.
- Target Sample Size
- 262
Eligibility
Recruits 262 Participants are a vulnerable population (people with Alzheimer’s disease and cognitive impairment). A caregiver/study partner is required (principal inclusion criterion): the caregiver must have sufficient contact (approximately 10 hours/week) and be willing to attend visits, oversee compliance, participate in assessments and "provide IC to participate in the study". Country-specific subject information/ICF and assent documents and study-partner ICFs are included (examples: Adult Assent, Study Partner ICF, country versions for IT/FR/CZ/HU/PL), indicating use of assent/consent processes adapted for cognitively impaired adults and involvement of study partners/caregivers in consent..
- Vulnerable Population
- Participants are a vulnerable population (people with Alzheimer’s disease and cognitive impairment). A caregiver/study partner is required (principal inclusion criterion): the caregiver must have sufficient contact (approximately 10 hours/week) and be willing to attend visits, oversee compliance, participate in assessments and "provide IC to participate in the study". Country-specific subject information/ICF and assent documents and study-partner ICFs are included (examples: Adult Assent, Study Partner ICF, country versions for IT/FR/CZ/HU/PL), indicating use of assent/consent processes adapted for cognitively impaired adults and involvement of study partners/caregivers in consent.
Inclusion criteria
- {"criterion_text":"- A diagnosis of Alzheimer’s disease (AD) in accordance with the 2024 Alzheimer’s Association criteria with one of the the following confirmations of AD pathology: \t- Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. \t- If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval. B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following: o Amyloid PET o Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay\n- Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1)\n- Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to: - Attend all visits and report on participant’s status - Oversee participant compliance with medication and study procedures - Participate in the study assessments and provide IC to participate in the study\n- History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n- AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 3 at Screening (Visit 1) and Baseline (Visit 4).\n- CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 4)\n- At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 4; CMAI-IPA Physical/Verbal Aggression Positivity): - 1 or more aggressive behaviors occurring several times per week - 2 or more aggressive behaviors occurring once or twice per week - 3 or more aggressive behaviors occurring less than once per week"}
Exclusion criteria
- {"criterion_text":"- Medical Conditions Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia History of bipolar disorder, schizophrenia, or schizoaffective disorder History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator Risk of suicidal behavior during the study as determined by the Investigator’s clinical assessment and/or C-SSR\n- Prior/Concomitant Therapy - Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam) Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1)\n- Other protocol-defined Inclusion/Exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline to the end of treatment on the CMAI-IPA total score compared with placebo.","definition_or_measurement_approach":"Change from baseline to end of treatment measured using the Cohen-Mansfield Agitation Inventory – International Psychogeriatric Association (CMAI-IPA) total score."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline to the end of treatment on the CGI-S as it relates specifically to agitation compared with placebo.","definition_or_measurement_approach":"Change from baseline to end of treatment measured using the Clinical Global Impressions – Severity (CGI-S) score specifically related to agitation."}
Recruitment
- Planned Sample Size
- 262
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent and assent processes account for cognitively impaired participants: study requires a caregiver/study partner who will attend visits, oversee compliance and "provide IC to participate in the study". Subject information and ICF documents (and assent forms) are provided in country-specific versions (documents available for IT, FR, CZ, HU, PL) and there are study partner ICFs and adult assent templates indicated, i.e. consent obtained using participant ICF when possible and using caregiver/study partner ICF/consent and assent processes adapted for participants with cognitive impairment.
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 92
Italy
- Earliest CTIS Part Ii Submission Date
- 04-08-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 217
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Medicina Interna Geriatrica
- Principal Investigator Name
- Francesco Landi
- Principal Investigator Email
- francesco.landi@policlinicogemelli.it
- Contact Person Name
- Francesco Landi
- Contact Person Email
- francesco.landi@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Neuroscience
- Principal Investigator Name
- Vincenzo Brescia Morra
- Principal Investigator Email
- Vincenzo.bresciamorra2@unina.it
- Contact Person Name
- Vincenzo Brescia Morra
- Contact Person Email
- Vincenzo.bresciamorra2@unina.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Psichiatria
- Principal Investigator Name
- Giulio Perugi
- Principal Investigator Email
- giulio.perugi@gmail.com
- Contact Person Name
- Giulio Perugi
- Contact Person Email
- giulio.perugi@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Human Neuroscience
- Principal Investigator Name
- Giuseppe Bruno
- Principal Investigator Email
- g.bruno@policlinicoumberto1.it
- Contact Person Name
- Giuseppe Bruno
- Contact Person Email
- g.bruno@policlinicoumberto1.it
- Site Name
- Istituto Auxologico Italiano
- Department Name
- Neurology
- Principal Investigator Name
- Nicola Ticozzi
- Principal Investigator Email
- trials@auxologico.it
- Contact Person Name
- Nicola Ticozzi
- Contact Person Email
- trials@auxologico.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- NESMOS
- Principal Investigator Name
- Franco Giubilei
- Principal Investigator Email
- franco.giubilei@uniroma1.it
- Contact Person Name
- Franco Giubilei
- Contact Person Email
- franco.giubilei@uniroma1.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- S.C. Neurologia
- Principal Investigator Name
- Salvatore Caratozzolo
- Principal Investigator Email
- salvatore.caratozzolo@hotmail.com
- Contact Person Name
- Salvatore Caratozzolo
- Contact Person Email
- salvatore.caratozzolo@hotmail.com
France
- Earliest CTIS Part Ii Submission Date
- 14-09-2025
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 177
- Number Of Sites
- 7
- Number Of Participants
- 17
Sites
- Site Name
- Hopitaux Universitaires de Strasbourg - Hopital de la Robertsau
- Department Name
- Centre Mémoire de Ressources et de Recherche (CMRR)
- Principal Investigator Name
- Alix Ravier
- Principal Investigator Email
- alix.ravier@chru-strasbourg.fr
- Contact Person Name
- Alix Ravier
- Contact Person Email
- alix.ravier@chru-strasbourg.fr
- Site Name
- Hospices Civils de Lyon (HCL) - Hôpital des Charpennes
- Department Name
- Centre de Recherche Clinique Vieillissement Cerveau Fragilité (CRC VCF)
- Principal Investigator Name
- Antoine Garnier-Crussard
- Principal Investigator Email
- antoine.garnier-crussard@chu-lyon.fr
- Contact Person Name
- Antoine Garnier-Crussard
- Contact Person Email
- antoine.garnier-crussard@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Gérontopole - Centre de Recherche Clinique (CRC)
- Principal Investigator Name
- Maria Eugenia Soto-Martin
- Principal Investigator Email
- soto-martin.me@chu-toulouse.fr
- Contact Person Name
- Maria Eugenia Soto-Martin
- Contact Person Email
- soto-martin.me@chu-toulouse.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Hôpital Dupuytren - Service de médecine gériatrique
- Principal Investigator Name
- Achille Tchalla
- Principal Investigator Email
- achille.tchalla@chu-limoges.fr
- Contact Person Name
- Achille Tchalla
- Contact Person Email
- achille.tchalla@chu-limoges.fr
- Site Name
- Hopital Fernand Widal
- Department Name
- Centre de neurologie cognitive
- Principal Investigator Name
- Emmanuel Cognat
- Principal Investigator Email
- emmanuel.cognat@aphp.fr
- Contact Person Name
- Emmanuel Cognat
- Contact Person Email
- emmanuel.cognat@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hopital Gui de Chauliac - Centre Mémoire de Ressources et de Recerches (CMRR)
- Principal Investigator Name
- Karim Bennys
- Principal Investigator Email
- k-bennys@chu-montpellier.fr
- Contact Person Name
- Karim Bennys
- Contact Person Email
- k-bennys@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Hopital Roger Salengro - Centre Mémoire de Ressources et de Recerches (CMRR)
- Principal Investigator Name
- Lionel Trogneux
- Principal Investigator Email
- lionel.trogneux@chu-lille.fr
- Contact Person Name
- Lionel Trogneux
- Contact Person Email
- lionel.trogneux@chu-lille.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-09-2025
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 162
- Number Of Sites
- 7
- Number Of Participants
- 14
Sites
- Site Name
- Gyoengyosi Bugat Pal Koerhaz
- Department Name
- Pszichiatria
- Principal Investigator Name
- Tibor Kelemen
- Principal Investigator Email
- junto@t-online.hu
- Contact Person Name
- Tibor Kelemen
- Contact Person Email
- junto@t-online.hu
- Site Name
- Dr. Mathe Es Tarsa Bt.
- Principal Investigator Name
- Eva Mathe
- Principal Investigator Email
- matheevazs@gmail.com
- Contact Person Name
- Eva Mathe
- Contact Person Email
- matheevazs@gmail.com
- Site Name
- Semmelweis University
- Department Name
- Neurológiai Klinika
- Principal Investigator Name
- Tibor Kovacs
- Principal Investigator Email
- kovacs.tibor@semmelweis.hu
- Contact Person Name
- Tibor Kovacs
- Contact Person Email
- kovacs.tibor@semmelweis.hu
- Site Name
- University Of Debrecen
- Department Name
- Neurologiai Klinika
- Principal Investigator Name
- Palma Piros
- Principal Investigator Email
- pirospalma@gmail.com
- Contact Person Name
- Palma Piros
- Contact Person Email
- pirospalma@gmail.com
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Pszichiatriai, Mentalhigienes és Addiktologiai Osztaly
- Principal Investigator Name
- Gabor Feller
- Principal Investigator Email
- fellerg@petz.gyor.hu
- Contact Person Name
- Gabor Feller
- Contact Person Email
- fellerg@petz.gyor.hu
- Site Name
- Clinexpert Kft.
- Principal Investigator Name
- Istvan Kapas
- Principal Investigator Email
- istvan.kapas00@gmail.com
- Contact Person Name
- Istvan Kapas
- Contact Person Email
- istvan.kapas00@gmail.com
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Lehel Finta
- Principal Investigator Email
- lehel.finta@oec.hu
- Contact Person Name
- Lehel Finta
- Contact Person Email
- lehel.finta@oec.hu
Czechia
- Earliest CTIS Part Ii Submission Date
- 23-09-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 167
- Number Of Sites
- 7
- Number Of Participants
- 21
Sites
- Site Name
- INEP medical s.r.o.
- Principal Investigator Name
- Alexander Nawka
- Principal Investigator Email
- nawka@inep.cz
- Contact Person Name
- Alexander Nawka
- Contact Person Email
- nawka@inep.cz
- Site Name
- Neuropsychiatrie s.r.o.
- Principal Investigator Name
- Jakub Hort
- Principal Investigator Email
- jakub.hort@gmail.com
- Contact Person Name
- Jakub Hort
- Contact Person Email
- jakub.hort@gmail.com
- Site Name
- A-Shine s.r.o.
- Principal Investigator Name
- Lubos Janu
- Principal Investigator Email
- lubos.janu@seznam.cz
- Contact Person Name
- Lubos Janu
- Contact Person Email
- lubos.janu@seznam.cz
- Site Name
- Neuro Health Centrum s.r.o.
- Principal Investigator Name
- Katerina Sheardova
- Principal Investigator Email
- nhctrials@gmail.com
- Contact Person Name
- Katerina Sheardova
- Contact Person Email
- nhctrials@gmail.com
- Site Name
- Neurohk s.r.o.
- Principal Investigator Name
- Martin Valis
- Principal Investigator Email
- valismar@seznam.cz
- Contact Person Name
- Martin Valis
- Contact Person Email
- valismar@seznam.cz
- Site Name
- Vestra Clinics s.r.o.
- Principal Investigator Name
- Ladislav Pazdera
- Principal Investigator Email
- pazdera@vestraclinics.org
- Contact Person Name
- Ladislav Pazdera
- Contact Person Email
- pazdera@vestraclinics.org
- Site Name
- AGE Centrum s.r.o.
- Principal Investigator Name
- Dagmar Malotova
- Principal Investigator Email
- malotova@ctcenter.cz
- Contact Person Name
- Dagmar Malotova
- Contact Person Email
- malotova@ctcenter.cz
Poland
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 172
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- Centrum Medyczne Hcp Sp. z o.o.
- Department Name
- Oddział Udarowy i Neurologii, Ośrodek Badań Klinicznych
- Principal Investigator Name
- Przemyslaw Osip
- Principal Investigator Email
- przemyslaw.osip@cmhcp.pl
- Contact Person Name
- Przemyslaw Osip
- Contact Person Email
- przemyslaw.osip@cmhcp.pl
- Site Name
- Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
- Principal Investigator Name
- Marcin Nastaj
- Principal Investigator Email
- marcinnastaj@gmail.com
- Contact Person Name
- Marcin Nastaj
- Contact Person Email
- marcinnastaj@gmail.com
- Site Name
- M2M Med. Sp. z o.o. Sp. j.
- Principal Investigator Name
- Anna Starostka-Tatar
- Principal Investigator Email
- a.starostka-tatar@m2m-badania.pl
- Contact Person Name
- Anna Starostka-Tatar
- Contact Person Email
- a.starostka-tatar@m2m-badania.pl
- Site Name
- Centrum Medyczne Neuromed Sp. z o.o.
- Principal Investigator Name
- Paweł Lisewski
- Principal Investigator Email
- lisewski.p@gmail.com
- Contact Person Name
- Paweł Lisewski
- Contact Person Email
- lisewski.p@gmail.com
- Site Name
- Centrum In Psyche Spersonalizowanej Psychiatrii i Terapii
- Principal Investigator Name
- Agnieszka Prymus
- Principal Investigator Email
- rejestracjapsyche@gmail.com
- Contact Person Name
- Agnieszka Prymus
- Contact Person Email
- rejestracjapsyche@gmail.com
- Site Name
- Rcmed Oddzial Sochaczew
- Principal Investigator Name
- Małgorzata Fengler-Czeczko
- Principal Investigator Email
- malgorzata.fenglerczeczko@rcmed.com.pl
- Contact Person Name
- Małgorzata Fengler-Czeczko
- Contact Person Email
- malgorzata.fenglerczeczko@rcmed.com.pl
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Iqvia Holdings Inc.
- Responsibilities
- Site Payments
- Name
- Syneos Health Inc.
- Responsibilities
- Subject Eligibility Review
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"PRO/COA management, rater training, and supply of electronic devices for the collection of eCOA assessments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Safety Laboratory testing and pTau217/AB42, pTau181/AB42, AB42/40 Biomarker testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Subject Eligibility Review","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KarXT
- Active Substance
- trospium chloride, xanomeline tartrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Investigational Product Name
- KarX-EC
- Active Substance
- xanomeline tartrate
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Investigational Product Name
- KarXT matching placebo
- Modality
- Other
- Investigational Product Name
- KarX-EC matching Placebo
- Modality
- Other
- Combination Treatment
- Yes
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