Clinical trial • Phase III • Psychiatry

TROSPIUM CHLORIDE; XANOMELINE TARTRATE for Alzheimer's disease (mild to moderate)

Phase III trial of TROSPIUM CHLORIDE; XANOMELINE TARTRATE for Alzheimer's disease (mild to moderate).

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Alzheimer's disease (mild to moderate)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-06-2025
First CTIS Authorization Date
21-10-2025

Trial design

Randomised, karxt matching placebo; karx-ec matching placebo (doses and schedules not specified in the record).-controlled Phase III trial in Croatia, Czechia, Germany and others.

Randomised
Yes
Comparator
KarXT matching placebo; KarX-EC matching placebo (doses and schedules not specified in the record).
Target Sample Size
361
Trial Duration For Participant
168

Eligibility

Recruits 361 Vulnerable population selected: participants are older adults with mild to moderate Alzheimer's disease (cognitive impairment). A designated caregiver/study partner is required (maintain ~10 hours/week contact, attend study visits, report on condition, oversee medication and assist with administration). Assent and study-partner/study-partner/caregiver information and consent documents are provided (multiple country-specific forms and assent/study partner documents listed in the filing)..

Vulnerable Population
Vulnerable population selected: participants are older adults with mild to moderate Alzheimer's disease (cognitive impairment). A designated caregiver/study partner is required (maintain ~10 hours/week contact, attend study visits, report on condition, oversee medication and assist with administration). Assent and study-partner/study-partner/caregiver information and consent documents are provided (multiple country-specific forms and assent/study partner documents listed in the filing).

Inclusion criteria

  • {"criterion_text":"- Males and females aged between 60 and 85 years."}
  • {"criterion_text":"- Participants must have an MMSE score ranging from 12 through 22, inclusive, at the time of screening."}
  • {"criterion_text":"- Participants are required to have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication and study procedure compliance, and assisting with medication administration."}
  • {"criterion_text":"- Participants on AChEIs and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration."}

Exclusion criteria

  • {"criterion_text":"- Participants with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment."}
  • {"criterion_text":"- Participants with primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and to those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion."}
  • {"criterion_text":"- Participants with a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening."}
  • {"criterion_text":"- Participants with significant pathological findings on brain MRI at screening that could affect safety or interfere with study procedures."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in ADAS-Cog11 at Week 24","definition_or_measurement_approach":"Change from baseline in ADAS-Cog11 measured at Week 24 (as stated)."}
  • {"endpoint_text":"- CIBIC+ at Week 24","definition_or_measurement_approach":"Not specified in the record (endpoint given as 'CIBIC+ at Week 24')."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in ADCS-ADL at Week 24","definition_or_measurement_approach":"Change from baseline in ADCS-ADL measured at Week 24 (as stated)."}
  • {"endpoint_text":"- Change from baseline in NPI total score at Week 24","definition_or_measurement_approach":"Change from baseline in NPI total score measured at Week 24 (as stated)."}
  • {"endpoint_text":"- Occurence of AEs and SAEs, AESIs, AEs leading to study intervention discontinuation, AEs leading to study discontinuation, and AEs leading to death through Week 24","definition_or_measurement_approach":"Safety events (AEs/SAEs/AESIs and related discontinuations/deaths) tracked through Week 24 (as stated)."}
  • {"endpoint_text":"- Incidence and severity of clinically significant changes in vital signs, ECG, C-SSRS, weight, and safety laboratory tests through Week 24","definition_or_measurement_approach":"Incidence and severity of clinically significant changes in listed safety measures recorded through Week 24 (as stated)."}

Recruitment

Planned Sample Size
361
Recruitment Window Months
44
Consent Approach
Informed consent materials (SIS and ICF) are provided for participants; study partner/caregiver information and consent forms are available; assent forms are available (country-specific assent documents listed). Multiple language/site-specific informed consent and assent documents are included (examples in German, Croatian, Czech, Polish, Greek, Spanish, Romanian, Italian, English and others). The study requires a designated caregiver/study partner to participate in reporting and support; participant consent supplemented by study partner/caregiver documentation and assent where applicable.

Geography

Total Number Of Sites
45
Total Number Of Participants
225

Croatia

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
32
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Clinical Hospital Centre Rijeka
Department Name
Klinika za neurologiju
Contact Person Name
Vladimira Vuletić
Contact Person Email
vladimira.vuletic@gmail.com
Site Name
Klinika za psihijatriju Vrapce
Department Name
Zavod za biologijsku psihijatriju i psihogerijatriju
Contact Person Name
Ninoslav Mimica
Contact Person Email
bolnica@bolnica-vrapce.hr
Site Name
Poliklinika Neuron
Department Name
Psihijatrija
Contact Person Name
Neven Henigsberg
Contact Person Email
neven.henigsberg@zg.ht.hr
Site Name
Klinicki Bolnicki Centar Osijek
Department Name
Klinika za neurologiju
Contact Person Name
Ivanka Štenc Bradvica
Contact Person Email
ivanka.stenc@vip.hr
Site Name
KBC Zagreb
Department Name
Klinika za neurologiju
Contact Person Name
Nataša Klepac
Contact Person Email
natasaklepac@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
04-09-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
48
Number Of Sites
8
Number Of Participants
45

Sites

Site Name
Neuro Health Centrum s.r.o.
Contact Person Name
Katerina Sheardova
Contact Person Email
nhctrials@gmail.com
Site Name
INEP medical s.r.o.
Contact Person Name
Alexander Nawka
Contact Person Email
clinicaltrials@inep.cz
Site Name
Vestra Clinics s.r.o.
Contact Person Name
Ladislav Pazdera
Contact Person Email
pazdera@vestraclinics.org
Site Name
A-Shine s.r.o.
Contact Person Name
Lubos Janu
Contact Person Email
lubos.janu@seznam.cz
Site Name
AGE Centrum s.r.o.
Contact Person Name
Dagmar Malotova
Contact Person Email
malotova@ctcenter.cz
Site Name
Forbeli s.r.o.
Contact Person Name
Michal Bajacek
Contact Person Email
mbajacek@yahoo.co.uk
Site Name
Neuropsychiatrie s.r.o.
Contact Person Name
Jakub Hort
Contact Person Email
jakub.hort@gmail.com
Site Name
A further NA site listed in Czechia block

Germany

Earliest CTIS Part Ii Submission Date
18-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
33
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Zentrum für kognitive Störungen
Contact Person Name
Timo Grimmer
Contact Person Email
t.grimmer@tum.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Neurologie
Contact Person Name
Goetz Thomalla
Contact Person Email
thomalla@uke.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Psychiatrie und Psychotherapie
Contact Person Name
Julian Hellmann-Regen
Contact Person Email
julian.hellmann@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik für Psychatrie und Psychotherapie
Contact Person Name
Susanne Englisch
Site Name
Universitaet Muenster
Department Name
Klinik für Neurologie mit Institut für Translationale Neurologie
Contact Person Name
Matthias Pawlowski
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Klinik für Neurologie
Contact Person Name
Thomas Duning

Greece

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
77
Number Of Sites
5
Number Of Participants
32

Sites

Site Name
General University Hospital Of Larissa
Department Name
Department of Neurology
Contact Person Name
Efthimios Dardiotis
Contact Person Email
edar@med.uth.gr
Site Name
Eginitio Hospital
Department Name
A’ Department of Neurology
Contact Person Name
Nikolaos Scarmeas
Contact Person Email
ns257@columbia.edu
Site Name
401 General Military Hospital Of Athens
Department Name
Department of Neurology
Contact Person Name
Nikolaos Fakas
Contact Person Email
drfakas@gmail.com
Site Name
University General Hospital Of Alexandroupoli
Department Name
Department of Neurology
Contact Person Name
Konstantinos Vadikolias
Contact Person Email
kvadikol@med.duth.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
B’ Department of Neurology
Contact Person Name
Nikolaos Grigoriadis
Contact Person Email
grigoria@med.auth.gr

Italy

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
104
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Neurology
Contact Person Name
Salvatore Caratozzolo
Site Name
Azienda Ospedaliera S Gerardo Di Monza Laboratorio Per La Terapia Cellulare E Genica Stefano Verri
Department Name
Neurology
Contact Person Name
Fulvio Da Re
Contact Person Email
dare.fulvio@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Neurology
Contact Person Name
Andrea Arighi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Neurology
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it

Romania

Earliest CTIS Part Ii Submission Date
11-09-2025
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
46
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Institutul Național de Gerontologie și Geriatrie​ "Ana Aslan"
Department Name
Psychiatry
Contact Person Name
Traian Purnichi
Contact Person Email
traian.purnichi@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psychiatry
Contact Person Name
Laura Cristina Dolis
Contact Person Email
drcristinadolis@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psychiatry
Contact Person Name
Mihaela Cleopatra Rosca
Contact Person Email
mihaelarosca@gmail.com
Site Name
Institutul De Psihiatrie Socola Iasi
Department Name
Psychiatry
Contact Person Name
Cristinel Stefanescu
Contact Person Email
cristinel.stefanescu@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psychiatry
Contact Person Name
Corina Mihaela Nicolae
Contact Person Email
corina_panzaru@yahoo.com
Site Name
A further listed Romanian site

Spain

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
13
Number Of Sites
6
Number Of Participants
34

Sites

Site Name
Hospital Universitari De Santa Maria
Department Name
Cognitive Impairment Unit
Contact Person Name
Gerard Piñol
Contact Person Email
gpinol@gss.cat
Site Name
Hospital Universitari General De Catalunya
Contact Person Name
Alexander Nawka
Contact Person Email
clinicaltrials@inep.cz
Site Name
Hospital Victoria Eugenia De La Cruz Roja Espanola
Department Name
UNIDAD DE NEUROCIENCIAS
Contact Person Name
Felix Viñuela Fernandez
Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Contact Person Name
Jordi Matias-Guiu
Site Name
Hospital Clinic De Barcelona
Department Name
Alzheimer's disease and other cognitive disorders unit
Contact Person Name
Albert Llado Plarrumani
Contact Person Email
allado@clinic.cat
Site Name
Clinica Universidad De Navarra
Department Name
Neurology
Contact Person Name
Mario Riverol Fernández
Contact Person Email
mriverol@unav.es

Poland

Earliest CTIS Part Ii Submission Date
18-09-2025
Latest Decision Or Authorization Date
26-10-2025
Processing Time Days
38
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Department Name
-
Contact Person Name
Katarzyna Binkowska Michalik
Contact Person Email
k.binkmich@pihouse.pl
Site Name
Centrum Medyczne Hcp Sp. z o.o.
Department Name
-
Contact Person Name
Przemyslaw Osip
Contact Person Email
przemyslaw.osip@cmhcp.pl
Site Name
Osrodek Badan Klinicznych Clinsante s.c.
Department Name
-
Contact Person Name
Marzena Maryniak-Wisniewska
Site Name
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski
Department Name
-
Contact Person Name
Joanna Lazarczyk
Contact Person Email
joannalaz@wp.pl
Site Name
A further listed Polish site
Department Name
-

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Eligibility Review
Name
Clario
Responsibilities
ECG
Name
Iqvia Inc.
Responsibilities
Site Payments
Name
Medidata Solutions Inc.
Responsibilities
Data Management Platform
Name
Signant Health LLC
Responsibilities
Electronic Clinical Outcomes (eCOA), Rater training and qualification, and scientific trend analysis services

Third parties

  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Eligibility Review","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"ECG","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Clinical chemistry, Clinical haematology, Serology, endocrinology and plasma testing, CSF testing, Storage of biomarkers and residual biomarkers tested","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Travel Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"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":"Electronic Clinical Outcomes (eCOA), Rater training and qualification, and scientific trend analysis services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Techdata Service Company LLC","duties_or_roles":"Biostatistics and Statistical Programming. DMC Support","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
KarXT
Active Substance
TROSPIUM CHLORIDE; XANOMELINE TARTRATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 1)
Maximum Dose
9999 mg
Investigational Product Name
KarX-EC
Active Substance
XANOMELINE TARTRATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 1)
Maximum Dose
9999 mg
Investigational Product Name
KarXT matching placebo
Modality
Other
Investigational Product Name
KarX-EC matching placebo
Modality
Other
Combination Treatment
Yes

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