Clinical trial • Phase III • Psychiatry

Xanomeline tartrate for Agitation associated with Alzheimer's disease | Alzheimer's disease

Phase III trial of Xanomeline tartrate for Agitation associated with Alzheimer's disease | Alzheimer's disease. open-label, none/not specified-controlled.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Agitation associated with Alzheimer's disease | Alzheimer's disease
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

open-label, none/not specified-controlled Phase III trial across 84 sites in France, Czechia, Bulgaria and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
409

Eligibility

Recruits 409 Participants have agitation associated with Alzheimer's disease and are a vulnerable (cognitively impaired) population. Participants must sign a new informed consent form and must continue to have a caregiver who accompanies them to all study visits, ensures medication adherence and compliance with study rules, and agrees to participate in interviews and questionnaires about the participant’s behavior. Assent and adult-assent documents and Study Partner/ caregiver information and ICFs are included in the study documentation..

Vulnerable Population
Participants have agitation associated with Alzheimer's disease and are a vulnerable (cognitively impaired) population. Participants must sign a new informed consent form and must continue to have a caregiver who accompanies them to all study visits, ensures medication adherence and compliance with study rules, and agrees to participate in interviews and questionnaires about the participant’s behavior. Assent and adult-assent documents and Study Partner/ caregiver information and ICFs are included in the study documentation.

Inclusion criteria

  • {"criterion_text":"- The participants who can participate in this study are those who have finished either study CN0120023 or CN0120024.\n- Participants also must sign a new informed consent form and continue to have a caregiver who can continue to accompany them to all study visits, make sure they take their medication and follow the study rules, and agree to participate in interviews and questionnaires about the participant’s behavior (approximately 10 hours a week or more)."}

Exclusion criteria

  • {"criterion_text":"- Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of any Treatment-Emergent Adverse Events (TEAEs).","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths","definition_or_measurement_approach":""}
  • {"endpoint_text":"- AEs of special interest","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Assessment of abnormal involuntary movements or restlessness","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Body weight","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Blood pressure and heart rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Laboratory evaluations","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Suicidal ideation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Assessment of cognition","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Assessment of urinary retention.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
409
Recruitment Window Months
44
Consent Approach
Participants must sign a new informed consent form. A caregiver/study partner must continue to accompany participants to all study visits, ensure medication adherence and study rule compliance, and agree to participate in interviews and questionnaires. Assent/adult-assent forms and study partner ICFs are provided. Subject information and ICF documents are available in multiple country-specific languages (examples in the submitted documents include French, Czech, Bulgarian, Greek, Italian, Portuguese, Polish, Croatian and English).

Methods

  • Participants must have finished either study CN0120023 or CN0120024 (re-enrolment of participants from prior parent studies).

Geography

Total Number Of Sites
84
Total Number Of Participants
193

France

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
204
Number Of Sites
7
Number Of Participants
17

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gerontopole Clinical Research Center
Principal Investigator Name
Maria Soto-Martin
Principal Investigator Email
soto-martin.me@chu-toulouse.fr
Contact Person Name
Maria Soto-Martin
Contact Person Email
soto-martin.me@chu-toulouse.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Geriatric Medicine
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
Hospices Civils De Lyon
Department Name
Geriatric Medicine
Principal Investigator Name
Antoine Garnier-Crussard
Principal Investigator Email
antoine.garnier-crussard@chu-lyon.fr
Contact Person Name
Antoine Garnier-Crussard
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Neurology
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
Les Hopitaux Universitaires De Strasbourg
Department Name
Memory center for Resources and Research
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
Assistance Publique Hopitaux De Paris
Department Name
cognitive neurology center
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 Lille
Department Name
Memory center for Resources and Research
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

Czechia

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
218
Number Of Sites
7
Number Of Participants
21

Sites

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
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
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
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
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
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
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

Bulgaria

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
181
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Outpatient Clinic for Indiv. Practice for Spec.Med. Care in Psychiatry-Dr.Madlena Dimitrova Borisova
Department Name
Psychiatry
Principal Investigator Name
Maria Borisova
Principal Investigator Email
dr.madlena.d.borisova@gmail.com
Contact Person Name
Maria Borisova
Site Name
Diagnostics-Consultancy Center Mladost M Varna OOD
Department Name
Psychiatry
Principal Investigator Name
Hristo Kozhuharov
Principal Investigator Email
mcoffice@mkmladost.com
Contact Person Name
Hristo Kozhuharov
Contact Person Email
mcoffice@mkmladost.com
Site Name
Mental Health Center Sofia EOOD
Department Name
Department for active treatment of individuals with severe psychiatric disorders – Psychiatry, Level
Principal Investigator Name
Emil Grashnov
Principal Investigator Email
xxxx@xxxx.com
Contact Person Name
Emil Grashnov
Contact Person Email
xxxx@xxxx.com
Site Name
Medical Center Saint Naum EOOD
Department Name
Psychiatry
Principal Investigator Name
Asen Karadaliev
Principal Investigator Email
xxxx@xxxx.com
Contact Person Name
Asen Karadaliev
Contact Person Email
xxxx@xxxx.com
Site Name
Medical Center Medconsult Pleven OOD
Department Name
Psychiatry
Principal Investigator Name
Maria Aleksandrova
Principal Investigator Email
xxxx@xxxx.com
Contact Person Name
Maria Aleksandrova
Contact Person Email
xxxx@xxxx.com

Italy

Earliest CTIS Part Ii Submission Date
04-08-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
246
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Istituto Auxologico Italiano
Department Name
Neurology
Principal Investigator Name
Nicola Ticozzi
Principal Investigator Email
n.ticozzi@auxologico.it
Contact Person Name
Nicola Ticozzi
Contact Person Email
n.ticozzi@auxologico.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
Neuroscienze
Principal Investigator Name
Giuseppe Bruno
Principal Investigator Email
g.bruno@policlinoumberto1.it
Contact Person Name
Giuseppe Bruno
Contact Person Email
g.bruno@policlinoumberto1.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
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
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
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

Portugal

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
221
Number Of Sites
5
Number Of Participants
8

Sites

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
Joana Meireles
Contact Person Name
Joana Meireles
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Neurology
Principal Investigator Name
Ana Verdelho
Principal Investigator Email
xxxxx@xxxx.com
Contact Person Name
Ana Verdelho
Contact Person Email
xxxxx@xxxx.com
Site Name
CNS Saude Lda.
Department Name
Neurology
Principal Investigator Name
Camila Nobrega
Principal Investigator Email
xxxxx@xxxx.com
Contact Person Name
Camila Nobrega
Contact Person Email
xxxxx@xxxx.com

Croatia

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
204
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Opca Bolnica Varazdin
Department Name
Neurology
Principal Investigator Name
Spomenka Kiđemet Piskač
Principal Investigator Email
spiskac@gmail.com
Contact Person Name
Spomenka Kiđemet Piskač
Contact Person Email
spiskac@gmail.com
Site Name
KBC Split
Department Name
Psychiatry
Principal Investigator Name
Trpimir Glavina
Principal Investigator Email
psihijatrija@kbsplit.hr
Contact Person Name
Trpimir Glavina
Contact Person Email
psihijatrija@kbsplit.hr
Site Name
Clinical Hospital Centre Rijeka
Department Name
Psychiatry
Principal Investigator Name
Vladimir Sabljić
Principal Investigator Email
vladimir.sabljic@ri.t-com.hr
Contact Person Name
Vladimir Sabljić
Contact Person Email
vladimir.sabljic@ri.t-com.hr
Site Name
KBC Zagreb
Department Name
Neurology
Principal Investigator Name
Nataša Klepac
Principal Investigator Email
natasaklepac@gmail.com
Contact Person Name
Nataša Klepac
Contact Person Email
natasaklepac@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
197
Number Of Sites
8
Number Of Participants
20

Sites

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
Site Name
Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii
Principal Investigator Name
Agnieszka Prymus
Principal Investigator Email
rejestracjainpsyche@gmail.com
Contact Person Name
Agnieszka Prymus
Contact Person Email
rejestracjainpsyche@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
Site Name
Centrum Medyczne Hcp Sp. z o.o.
Principal Investigator Name
Przemysław Osip
Principal Investigator Email
przemyslaw.osip@cmhcp.pl
Contact Person Name
Przemysław Osip
Contact Person Email
przemyslaw.osip@cmhcp.pl
Site Name
Instytut Naukowo-Badawczy Sp. z o.o.
Department Name
M&D Centrum Medyczne
Principal Investigator Name
Grzegorz Opielak
Principal Investigator Email
badania.kliniczne@vp.pl
Contact Person Name
Grzegorz Opielak
Contact Person Email
badania.kliniczne@vp.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Principal Investigator Name
Maciej Nastaj
Principal Investigator Email
marcinnastaj@gmail.com
Contact Person Name
Maciej Nastaj
Contact Person Email
marcinnastaj@gmail.com
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 Medyczne Neuromed Sp. z o.o. (Bydgoszcz site)
Principal Investigator Name
Paweł Lisewski
Principal Investigator Email
lisewski.p@gmail.com
Contact Person Name
Paweł Lisewski
Contact Person Email
lisewski.p@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
11-08-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
240
Number Of Sites
11
Number Of Participants
29

Sites

Site Name
Oroitu S.L.
Department Name
Neurologia
Principal Investigator Name
Manuel Fernandez
Principal Investigator Email
mfernandezm@oroitu.com
Contact Person Name
Manuel Fernandez
Contact Person Email
mfernandezm@oroitu.com
Site Name
Hospital Ruber Juan Bravo
Department Name
Neurologia
Principal Investigator Name
Juan Jose Lopez
Principal Investigator Email
jlopezlozano@xxx.com
Contact Person Name
Juan Jose Lopez
Contact Person Email
jlopezlozano@xxx.com
Site Name
Hospital Clinico San Carlos
Department Name
Neurologia
Principal Investigator Name
Jordi Matias-Guiu
Principal Investigator Email
jordi.matias-guiu@salud.madrid.org
Contact Person Name
Jordi Matias-Guiu
Site Name
Hospital Victoria Eugenia De La Cruz Roja Espanola
Department Name
Neurologia
Principal Investigator Name
Felix Vinuela
Contact Person Name
Felix Vinuela
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Neurologia
Principal Investigator Name
Jerzy Krupinski
Principal Investigator Email
jkrupinski@mutuaterrassa.es
Contact Person Name
Jerzy Krupinski
Contact Person Email
jkrupinski@mutuaterrassa.es
Site Name
Clinica Universidad De Navarra
Department Name
Neurologia
Principal Investigator Name
Mario Riverol
Principal Investigator Email
mriverol@unav.es
Contact Person Name
Mario Riverol
Contact Person Email
mriverol@unav.es
Site Name
Hospital General Universitario De Elche
Department Name
Neurologia
Principal Investigator Name
Maria Gloria Gonzalez
Principal Investigator Email
gonzalez_glocab@gva.es
Contact Person Name
Maria Gloria Gonzalez
Contact Person Email
gonzalez_glocab@gva.es
Site Name
Hospital Universitario Rio Hortega
Department Name
Neurologia
Principal Investigator Name
Juan Luis Munoz
Principal Investigator Email
jlmusa@xxx.com
Contact Person Name
Juan Luis Munoz
Contact Person Email
jlmusa@xxx.com
Site Name
Hospital Universitario De Salamanca
Department Name
Neurologia
Principal Investigator Name
Angel Luis Montejo
Principal Investigator Email
amontejo@usual.es
Contact Person Name
Angel Luis Montejo
Contact Person Email
amontejo@usual.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Neurologia
Principal Investigator Name
Carlos de la Cruz
Principal Investigator Email
carlosdelacruzcosme@xxx.com
Contact Person Name
Carlos de la Cruz
Contact Person Email
carlosdelacruzcosme@xxx.com
Site Name
Clinica Montecanal S.L.
Department Name
Neurologia
Principal Investigator Name
Antonio Oliveros-Cid
Principal Investigator Email
aoliverosc.neuropolis@xxx.com
Contact Person Name
Antonio Oliveros-Cid
Contact Person Email
aoliverosc.neuropolis@xxx.com

Hungary

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
222
Number Of Sites
9
Number Of Participants
14

Sites

Site Name
Semmelweis University
Department Name
Neurologiai 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
Clinexpert Kft.
Principal Investigator Name
Istvan Kapas
Principal Investigator Email
info@clinexpert.hu
Contact Person Name
Istvan Kapas
Contact Person Email
info@clinexpert.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pszichiatria
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
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
Obudai Egeszseguegyi Centrum Kft.
Principal Investigator Name
Lehel Finta
Principal Investigator Email
gabor.kiss@oecresearch.com
Contact Person Name
Lehel Finta
Contact Person Email
gabor.kiss@oecresearch.com
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
Gyoengyosi Bugat Pal Koerhaz
Department Name
Pszichiatria
Principal Investigator Name
Tibor Kelemen
Principal Investigator Email
weisz.peter@bugatpal.hu
Contact Person Name
Tibor Kelemen
Contact Person Email
weisz.peter@bugatpal.hu
Site Name
Additional Hungarian site 1
Site Name
Additional Hungarian site 2

Romania

Earliest CTIS Part Ii Submission Date
18-08-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
245
Number Of Sites
13
Number Of Participants
25

Sites

Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psychiatry
Principal Investigator Name
Valentin Matei
Principal Investigator Email
valipmatei@yahoo.com
Contact Person Name
Valentin Matei
Contact Person Email
valipmatei@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
Site Name
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Department Name
Psychiatry
Principal Investigator Name
Traian Barbu
Principal Investigator Email
trabar98@yahoo.com
Contact Person Name
Traian Barbu
Contact Person Email
trabar98@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 Cai Ferate Constanta
Department Name
Neurology
Principal Investigator Name
Ana Maria Ionescu
Principal Investigator Email
iuliusana@gmail.com
Contact Person Name
Ana Maria Ionescu
Contact Person Email
iuliusana@gmail.com
Site Name
Institutul De Psihiatrie Socola Iasi
Department Name
Psychiatry
Principal Investigator Name
Cristinel Stefanescu
Principal Investigator Email
trabar98@yahoo.com
Contact Person Name
Cristinel Stefanescu
Contact Person Email
trabar98@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Dr. Gheorghe Preda Sibiu
Department Name
Psychiatry
Principal Investigator Name
Ciprian Bacila
Principal Investigator Email
bacila_c@yahoo.com
Contact Person Name
Ciprian Bacila
Contact Person Email
bacila_c@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (additional contact)
Department Name
Psychiatry
Principal Investigator Name
Mihnea Manea
Principal Investigator Email
maneamihnea@gmail.com
Contact Person Name
Mihnea Manea
Contact Person Email
maneamihnea@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (additional contact 2)
Department Name
Psychiatry
Principal Investigator Name
Mihaela Cleopatra Rosca
Principal Investigator Email
mihaelarosca@gmail.com
Contact Person Name
Mihaela Cleopatra Rosca
Contact Person Email
mihaelarosca@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (additional contact 3)
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
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (additional contact 4)
Department Name
Psychiatry
Principal Investigator Name
Corina Mihaela Dolis
Principal Investigator Email
drcristinadolis@gmail.com
Contact Person Name
Corina Mihaela Dolis
Contact Person Email
drcristinadolis@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (additional contact 5)
Department Name
Psychiatry
Principal Investigator Name
Ana Ciobanu
Principal Investigator Email
adela.ciobanu@yahoo.com
Contact Person Name
Ana Ciobanu
Contact Person Email
adela.ciobanu@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia (additional contact 6)
Department Name
Psychiatry
Principal Investigator Name
Corina Mihaela Nicolae
Principal Investigator Email
corina_panzaru@yahoo.com
Contact Person Name
Corina Mihaela Nicolae
Contact Person Email
corina_panzaru@yahoo.com

Greece

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
212
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Euromedica General Clinic Of Thessaloniki
Department Name
Neurological Department
Principal Investigator Name
Magdalini Tsolaki
Principal Investigator Email
tsolakim@gmail.com
Contact Person Name
Magdalini Tsolaki
Contact Person Email
tsolakim@gmail.com
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
Eginitio Hospital
Department Name
First Department of Psychiatry
Principal Investigator Name
Nikolaos Stefanis
Principal Investigator Email
aneurology@med.uoa.gr
Contact Person Name
Nikolaos Stefanis
Contact Person Email
aneurology@med.uoa.gr
Site Name
Athens Medical Center S.A.
Department Name
Memory Clinic
Principal Investigator Name
Ioannis Papatriantafyllou
Principal Investigator Email
ipapatriantafyllou@gmail.com
Contact Person Name
Ioannis Papatriantafyllou
Contact Person Email
ipapatriantafyllou@gmail.com
Site Name
University General Hospital Of Ioannina
Department Name
Department of Neurology
Principal Investigator Name
Spyridon Konitsiotis
Principal Investigator Email
skonitso@uoi.gr
Contact Person Name
Spyridon Konitsiotis
Contact Person Email
skonitso@uoi.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
Henry Dunant Hospital Center
Department Name
2nd Neurological Clinic
Principal Investigator Name
Konstantina Yiannopoulou
Principal Investigator Email
info@dunant.gr
Contact Person Name
Konstantina Yiannopoulou
Contact Person Email
info@dunant.gr
Site Name
Eginitio Hospital (Athens)
Department Name
A’ Department of Neurology
Principal Investigator Name
Nikolaos Scarmeas
Principal Investigator Email
aneurology@med.uoa.gr
Contact Person Name
Nikolaos Scarmeas
Contact Person Email
aneurology@med.uoa.gr

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 Inc.
Responsibilities
Site Payments
Name
Endpoint Clinical Inc.
Responsibilities
Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"Clinical chemistry, Clinical haematology, Clinical microbiology and Safety Laboratory testing and pTau217/AB42, pTau181/AB42, AB42/40 Biomarker testing","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance: Medical review & Cases Data Entry.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global 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":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-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"}
  • {"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
Combination Treatment
Yes

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