Clinical trial • Phase III • Psychiatry

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

Phase III trial of 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, placebo-controlled: matching placebos (karxt matching placebo and karx-ec matching placebo) used as comparator arms; no dose or schedule for comparator explicitly stated in provided data. Phase III trial in Finland, France, Germany and others.

Randomised
Yes
Comparator
Placebo-controlled: matching placebos (KarXT matching placebo and KarX-EC matching placebo) used as comparator arms; no dose or schedule for comparator explicitly stated in provided data.
Target Sample Size
294
Trial Duration For Participant
168

Eligibility

Recruits 294 Vulnerable population selected (isVulnerablePopulationSelected = true). The trial enrols participants with mild to moderate cognitive impairment/Alzheimer's disease; caregiver/study partner involvement is mandatory (caregiver required to maintain ~10 hours/week contact and attend visits). Subject information and informed consent forms include dedicated documents for Legally Authorised Representatives (LAR), study partner, and assent, indicating consent may be obtained from the participant when capable or from an LAR/study partner as applicable. Multiple country-specific ICF/assent/LAR templates are provided..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). The trial enrols participants with mild to moderate cognitive impairment/Alzheimer's disease; caregiver/study partner involvement is mandatory (caregiver required to maintain ~10 hours/week contact and attend visits). Subject information and informed consent forms include dedicated documents for Legally Authorised Representatives (LAR), study partner, and assent, indicating consent may be obtained from the participant when capable or from an LAR/study partner as applicable. Multiple country-specific ICF/assent/LAR templates are provided.

Inclusion criteria

  • {"criterion_text":"- Males and females aged between 60 and 85 years.\n- Participants must have an MMSE score ranging from 12 through 22, inclusive, at the time of screening.\n- 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 assissting with medication administration.\n- 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.\n- 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.\n- 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.\n- 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 the ADAS-Cog11 score measured at Week 24 compared to baseline"}
  • {"endpoint_text":"- CIBIC+ at Week 24","definition_or_measurement_approach":"CIBIC+ (Clinician's Interview-Based Impression of Change plus caregiver input) assessed 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 score measured at Week 24"}
  • {"endpoint_text":"- Change from baseline in NPI total score at Week 24","definition_or_measurement_approach":"Change from baseline in Neuropsychiatric Inventory (NPI) total score at Week 24"}
  • {"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":"Incidence and categorisation of adverse events (AEs), serious adverse events (SAEs), AEs of special interest (AESIs), and AEs leading to discontinuation or death up to Week 24"}
  • {"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":"Assessment of clinically significant changes and their severity in vital signs, ECG, Columbia-Suicide Severity Rating Scale (C-SSRS), body weight, and laboratory safety tests up to Week 24"}

Recruitment

Registry Or Advocacy Recruitment
True, Fundacio Ace Institut Catala De Neurociencies Aplicades
Digital Remote Recruitment
True, digital/remote methods include CRST website recruitment text and online adverts ('CRST web site', 'Statement_Website text', and 'Ad short' materials).
Planned Sample Size
294
Recruitment Window Months
44
Consent Approach
Informed consent obtained using subject information sheets and ICFs; there are dedicated ICFs for study partners, Legally Authorised Representatives (LAR), and assent forms. Consent materials are available in multiple country-specific translations (documents available for FR, DE, IT, PT, PL, GR, ES, NL, RO, and English). Participants provide consent if capable; when participants lack capacity a LAR/guardian and study partner processes are provided. Caregiver/study partner involvement is mandated by inclusion criteria.

Methods

  • Short advertisements (e.g., 'Ad short' materials) — channel: advertisement; target audience: potential participants and caregivers (document: K2_Subject Recruitment material _Ad short 1).
  • Recruitment posters — country-specific posters available (documents titled 'Recruitment Poster' for FR, DE, IT, PL, PT, ES, NL and others); channel: printed posters and distribution at sites; target: patients/caregivers and HCPs.
  • Caregiver fact sheets — country-specific caregiver informational materials (Caregiver Fact Sheet in multiple languages) — channel: printed/handout; target: caregivers/study partners.
  • Website recruitment text/CRST web site — channel: site web pages (document 'K2_Subject Recruitment material_CRST web site', 'Statement_Website text'); target: public and caregivers; country-specific web content available.
  • HCP referral letters and HCP-facing fact sheets (Italy specific) — channel: HCP communications; target: healthcare professionals to facilitate referrals (document: HCP Referral Letter and Fact Sheet - V1_it).
  • Appointment reminder cards and patient appointment materials (Romania example) — channel: mailed/handed reminders to enrolled participants or those scheduling screenings.
  • Welcome presentations / site welcome materials (Netherlands materials referenced) — channel: in-clinic presentations; target: referred patients and caregivers.
  • Use of patient organisation / advocacy group for outreach (e.g., Fundacio Ace in Spain listed among trial sites) — channel: patient organisation networks; target: patients/caregivers.

Geography

Total Number Of Sites
57
Total Number Of Participants
292

Finland

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
28
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
Clinical Research Services Turku CRST Oy
Department Name
CRST Turku Oy
Principal Investigator Name
Juha Rinne
Principal Investigator Email
juha.rinne@crst.fi
Contact Person Name
Juha Rinne
Contact Person Email
juha.rinne@crst.fi
Site Name
University Of Eastern Finland
Department Name
Brain Reserach Unit, Faculty of Medicine
Principal Investigator Name
Sudhir Kurl
Principal Investigator Email
sudhir.kurl@uef.fi
Contact Person Name
Sudhir Kurl
Contact Person Email
sudhir.kurl@uef.fi
Site Name
Suomen Terveystalo Oy
Department Name
Terveystalo Helsinki
Principal Investigator Name
Petra Keski-Säntti
Principal Investigator Email
petra.keski-santti@terveystalo.com
Contact Person Name
Petra Keski-Säntti
Site Name
Suomen Terveystalo Oy
Department Name
Terveystalo Oulu
Principal Investigator Name
Hanna Ansakorpi
Principal Investigator Email
hanna.ansakorpi@terveystalo.com
Contact Person Name
Hanna Ansakorpi
Site Name
CRST Helsinki Oy
Department Name
CRST Helsinki Oy
Principal Investigator Name
Zsófia Lovró
Principal Investigator Email
zsofia.lovro@crst.fi
Contact Person Name
Zsófia Lovró
Contact Person Email
zsofia.lovro@crst.fi

France

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
39
Number Of Sites
12
Number Of Participants
50

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Lariboisière - Centre de Neurologie Cognitive
Principal Investigator Name
Julien DUMURGIER
Principal Investigator Email
julien.dumurgier@aphp.fr
Contact Person Name
Julien DUMURGIER
Contact Person Email
julien.dumurgier@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Broca, Département gériatrique
Principal Investigator Name
Hermine LENOIR
Principal Investigator Email
hermine.lenoir@aphp.fr
Contact Person Name
Hermine LENOIR
Contact Person Email
hermine.lenoir@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurologie
Principal Investigator Name
Vincent PLANCHE
Principal Investigator Email
vincent.planche@chu-bordeaux.fr
Contact Person Name
Vincent PLANCHE
Site Name
Hospices Civils De Lyon
Department Name
Hôpital neurologique Pierre Wertheimer, Service de Neuropsychologie, Unité 502
Principal Investigator Name
Hélène MOLLION
Principal Investigator Email
helene.mollion@chu-lyon.fr
Contact Person Name
Hélène MOLLION
Contact Person Email
helene.mollion@chu-lyon.fr
Site Name
CHRU De Nancy
Department Name
Hôpital centre Neurologie
Principal Investigator Name
Therese JONVEAUX
Principal Investigator Email
t.jonveaux@chru-nancy.fr
Contact Person Name
Therese JONVEAUX
Contact Person Email
t.jonveaux@chru-nancy.fr
Site Name
Les Hopitaux Nord-Ouest
Department Name
Gérontologie
Principal Investigator Name
Julien VERNAUDON
Principal Investigator Email
jvernaudon@hno.fr
Contact Person Name
Julien VERNAUDON
Contact Person Email
jvernaudon@hno.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hôpital de la Timone - Service de Neurologie et de Neuropsychologie
Principal Investigator Name
Mathieu CECCALDI
Principal Investigator Email
mathieu-pierre.ceccaldi@ap-hm.fr
Contact Person Name
Mathieu CECCALDI
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gérontopôle
Principal Investigator Name
Pierre Jean OUSSET
Principal Investigator Email
ousset.pj@chu-toulouse.fr
Contact Person Name
Pierre Jean OUSSET
Contact Person Email
ousset.pj@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hôpital Roger Salengro, Neurologie
Principal Investigator Name
Marie-Anne MACKOWIAK
Principal Investigator Email
marieanne.mackowiak@chru-lille.fr
Contact Person Name
Marie-Anne MACKOWIAK
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hôpital de la Robertsau - Centre Mémoire de Ressources et de Recherche
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
Hopitaux Universitaires Pitie Salpetriere
Department Name
Neurologie
Principal Investigator Name
Théophile BIETH
Principal Investigator Email
theophile.bieth@aphp.fr
Contact Person Name
Théophile BIETH
Contact Person Email
theophile.bieth@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Centre Mémoire de Ressource de Recherche (CMRR)
Principal Investigator Name
Cezara HANTA
Principal Investigator Email
cezara-roxana.hanta@chu-rennes.fr
Contact Person Name
Cezara HANTA

Germany

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
22
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Pharmakologisches Studienzentrum Chemnitz GmbH
Department Name
Pharmakologisches Studienzentrum Chemnitz
Principal Investigator Name
Ralf Bodenschatz
Contact Person Name
Ralf Bodenschatz
Site Name
LMU Klinikum Muenchen AöR
Department Name
Klinik fuer Psychiatrie und Psychotherapie
Principal Investigator Name
Robert Perneczky
Principal Investigator Email
Robert.Perneczky@med.uni-muenchen.de
Contact Person Name
Robert Perneczky
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Niels Hansen
Principal Investigator Email
niels.hansen@med.uni-goettingen.de
Contact Person Name
Niels Hansen
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Gedächtnissprechstunde und Studienteam Demenz
Principal Investigator Name
Doerte Polivka
Principal Investigator Email
doerte.polivka@uni-ulm.de
Contact Person Name
Doerte Polivka
Contact Person Email
doerte.polivka@uni-ulm.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Franziska Maier
Principal Investigator Email
franziska.maier@uk-koeln.de
Contact Person Name
Franziska Maier
Contact Person Email
franziska.maier@uk-koeln.de
Site Name
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Department Name
Dr. I. Schöll GmbH
Principal Investigator Name
Elvira Steidl
Principal Investigator Email
dr.steidl@forschung-badhomburg.de
Contact Person Name
Elvira Steidl

Greece

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
102
Number Of Sites
5
Number Of Participants
32

Sites

Site Name
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
Department Name
Neurodegenerative Brain Diseases Department – Memory Clinic
Principal Investigator Name
Paraskevi Sakka
Principal Investigator Email
Degen.brain@hygeia.gr
Contact Person Name
Paraskevi Sakka
Contact Person Email
Degen.brain@hygeia.gr
Site Name
General University Hospital Of Patras
Department Name
Department of Neurology
Principal Investigator Name
John Ellul
Principal Investigator Email
ellul@upatras.gr
Contact Person Name
John Ellul
Contact Person Email
ellul@upatras.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Department of Neurology
Principal Investigator Name
Vasilios Kimiskidis
Principal Investigator Email
kimiskid@auth.gr
Contact Person Name
Vasilios Kimiskidis
Contact Person Email
kimiskid@auth.gr
Site Name
University General Hospital Attikon
Department Name
2nd Department of Neurology
Principal Investigator Name
Georgios Tsivgoulis
Principal Investigator Email
tsivgoulisgiorg@yahoo.gr
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr
Site Name
University General Hospital Of Ioannina
Department Name
Neurology
Principal Investigator Name
Spyridon Konitsiotis
Principal Investigator Email
skonitso@uoi.gr
Contact Person Name
Spyridon Konitsiotis
Contact Person Email
skonitso@uoi.gr

Italy

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
41
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Neurology
Principal Investigator Name
Vincenzo Brescia Morra
Principal Investigator Email
dip.neuro-scienze-rip-odonto@unina.it
Contact Person Name
Vincenzo Brescia Morra
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Neurology
Principal Investigator Name
Camillo Marra
Principal Investigator Email
camillo.marra@policlinicogemelli.it
Contact Person Name
Camillo Marra
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Neurology
Principal Investigator Name
Carlo Avolio
Principal Investigator Email
carlo.avolio@unifg.it
Contact Person Name
Carlo Avolio
Contact Person Email
carlo.avolio@unifg.it

Portugal

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
32
Number Of Sites
7
Number Of Participants
32

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Neurology
Principal Investigator Name
Inês Laranjinha
Contact Person Name
Inês Laranjinha
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Neurology
Principal Investigator Name
Vítor Cruz
Principal Investigator Email
investigacao@ulsm.min-saude.pt
Contact Person Name
Vítor Cruz
Contact Person Email
investigacao@ulsm.min-saude.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Neurology
Principal Investigator Name
Maria Isabel Santana
Principal Investigator Email
xxxxx@xxxx.com
Contact Person Name
Maria Isabel Santana
Contact Person Email
xxxxx@xxxx.com
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Neurology
Principal Investigator Name
Miguel Gago
Contact Person Name
Miguel Gago
Site Name
CNS Saude Lda.
Department Name
Neurology
Principal Investigator Name
Joana Morgado
Principal Investigator Email
xxxxx@xxxx.com
Contact Person Name
Joana Morgado
Contact Person Email
xxxxx@xxxx.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Neurology
Principal Investigator Name
Álvaro Machado
Principal Investigator Email
xxxx@xxxx.com
Contact Person Name
Álvaro Machado
Contact Person Email
xxxx@xxxx.com
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Neurology
Principal Investigator Name
Vítor Cruz
Principal Investigator Email
investigacao@ulsm.min-saude.pt
Contact Person Name
Vítor Cruz
Contact Person Email
investigacao@ulsm.min-saude.pt

Romania

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
108
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psychiatry
Principal Investigator Name
Simona Trifu
Principal Investigator Email
simonatrifu@yahoo.com
Contact Person Name
Simona Trifu
Contact Person Email
simonatrifu@yahoo.com
Site Name
Brainaxy Clinic S.R.L.
Department Name
Neurology
Principal Investigator Name
Any Axelerad
Principal Investigator Email
docuaxi@yahoo.com
Contact Person Name
Any Axelerad
Contact Person Email
docuaxi@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psychiatry
Principal Investigator Name
Adela Ciobanu
Principal Investigator Email
adela.ciobanu@yahoo.com
Contact Person Name
Adela Ciobanu
Contact Person Email
adela.ciobanu@yahoo.com
Site Name
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Department Name
Psychiatry
Principal Investigator Name
Octavian Vasiliu
Principal Investigator Email
octavvasiliu@yahoo.com
Contact Person Name
Octavian Vasiliu
Contact Person Email
octavvasiliu@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Department Name
Psychiatry
Principal Investigator Name
Petru Ifteni
Principal Investigator Email
relatiicupublicul@spnbrasov.ro
Contact Person Name
Petru Ifteni
Contact Person Email
relatiicupublicul@spnbrasov.ro

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
7
Number Of Participants
36

Sites

Site Name
Hospital Ruber Juan Bravo
Department Name
Neurology
Principal Investigator Name
Juan Lopez Lozano
Principal Investigator Email
xxx@xxx
Contact Person Name
Juan Lopez Lozano
Contact Person Email
xxx@xxx
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neurology
Principal Investigator Name
Eloy Rodríguez Rodríguez
Principal Investigator Email
xxx@xxx
Contact Person Name
Eloy Rodríguez Rodríguez
Contact Person Email
xxx@xxx
Site Name
Policlinica Gipuzkoa S.A.
Department Name
Neurology
Principal Investigator Name
Gurutz Linazasoro
Principal Investigator Email
glinazasoro@vivebiotech.com
Contact Person Name
Gurutz Linazasoro
Contact Person Email
glinazasoro@vivebiotech.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurology
Principal Investigator Name
Rafael Arroyo
Principal Investigator Email
xxx@xxx
Contact Person Name
Rafael Arroyo
Contact Person Email
xxx@xxx
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Neurology
Principal Investigator Name
Lamberto Landete Pascual
Principal Investigator Email
landete_lam@gva.es
Contact Person Name
Lamberto Landete Pascual
Contact Person Email
landete_lam@gva.es
Site Name
Fundacio Ace Institut Catala De Neurociencies Aplicades
Department Name
Neurology
Principal Investigator Name
Juan Pablo Tartari
Principal Investigator Email
jptartari@fundacioace.com
Contact Person Name
Juan Pablo Tartari
Contact Person Email
jptartari@fundacioace.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neorology
Principal Investigator Name
Alberto Villarejo Galende
Principal Investigator Email
alberto.villarejo@salud.madrid.org
Contact Person Name
Alberto Villarejo Galende

Netherlands

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
19
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Brain Research Center Amsterdam B.V.
Department Name
Alzheimer centra
Principal Investigator Name
Paul Dautzenberg
Principal Investigator Email
info@brainresearchcenter.nl
Contact Person Name
Paul Dautzenberg
Contact Person Email
info@brainresearchcenter.nl
Site Name
Brain Research Center Den Bosch B.V.
Department Name
Alzheimer centra
Principal Investigator Name
Paul Dautzenberg
Principal Investigator Email
info@brainresearchcenter.nl
Contact Person Name
Paul Dautzenberg
Contact Person Email
info@brainresearchcenter.nl
Site Name
Brain Research Center Zwolle B.V.
Department Name
Alzheimer centra
Principal Investigator Name
Paul Dautzenberg
Principal Investigator Email
info@brainresearchcenter.nl
Contact Person Name
Paul Dautzenberg
Contact Person Email
info@brainresearchcenter.nl

Poland

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
53
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Penta Hospitals Przychodnie
Department Name
Wrocław Wejherowska
Principal Investigator Name
Monika Susz-Kolodynska
Principal Investigator Email
badania.kliniczne@pentahospitals.pl
Contact Person Name
Monika Susz-Kolodynska
Site Name
Instytut Naukowo-Badawczy w Lublinie Sp. z o.o.
Department Name
M&D Centrum Medyczne
Principal Investigator Name
Grzegorz Opielak
Principal Investigator Email
rejestracja@mdpolnocna.pl
Contact Person Name
Grzegorz Opielak
Contact Person Email
rejestracja@mdpolnocna.pl
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Principal Investigator Name
Magdalena Boczarska-Jedynak
Principal Investigator Email
info@instytutboczarska.pl
Contact Person Name
Magdalena Boczarska-Jedynak
Contact Person Email
info@instytutboczarska.pl
Site Name
EMC Silesia Sp. z o.o.
Department Name
Poradnia Geriatryczna
Principal Investigator Name
Martyna Zygmuntowska
Principal Investigator Email
badania.kliniczne@emc-sa.pl
Contact Person Name
Martyna Zygmuntowska
Contact Person Email
badania.kliniczne@emc-sa.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
Syneos Health Inc.
Responsibilities
Eligibility Review
Name
Iqvia Inc.
Responsibilities
Site Payments
Name
Medidata Solutions Inc.
Responsibilities
Data Management Platform
Name
Techdata Service Company LLC
Responsibilities
Biostatistics and Statistical Programming,DMC Support

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Travel Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global 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":"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":"Techdata Service Company LLC","duties_or_roles":"Biostatistics and Statistical Programming,DMC Support","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
  • {"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":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}

Investigational products

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
Active Substance
TROSPIUM CHLORIDE, XANOMELINE TARTRATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Investigational Product Name
KarX-EC matching placebo
Modality
Other
Investigational Product Name
KarXT matching placebo
Modality
Other
Combination Treatment
Yes

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