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NCT06937229RecruitingPhase 3

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
650 (estimated)
First submitted
15 Apr 2025
Start date
2 Dec 2025
Primary completion date
22 Jun 2029
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT06937229
EU CT number
2024-519994-20-00
EudraCT number
2024-519994-20

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 650
  • From 2 Dec 2025 to the primary completion date, 22 Jun 2029
  • 238 sites in 26 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Participants must have completed study CN012-0023 or CN012-0024 per protocol.
  • Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).

Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (238)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaNot yet recruiting
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Buenos AiresArgentinaNot yet recruiting
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Buenos AiresArgentinaNot yet recruiting
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Ciudad Autonoma de Buenos AiresArgentinaNot yet recruiting
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CórdobaArgentinaNot yet recruiting
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CórdobaArgentinaNot yet recruiting
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CórdobaArgentinaNot yet recruiting
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CórdobaArgentinaNot yet recruiting
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CórdobaArgentinaNot yet recruiting
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CórdobaArgentinaNot yet recruiting
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La PlataArgentinaNot yet recruiting
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Mar del PlataArgentinaNot yet recruiting
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MendozaArgentinaNot yet recruiting
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RosarioArgentinaNot yet recruiting
Medical Center Medconsult Pleven OOD
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PlevenBulgariaRecruiting
Outpatient Clinic for Indiv. Practice for Spec.Med. Care in Psychiatry-Dr.Madlena Dimitrova Borisova
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RazgradBulgariaRecruiting
Mental Health Center Sofia EOOD
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SofiaBulgariaRecruiting
Medical Center Saint Naum EOOD
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SofiyaBulgariaRecruiting
Diagnostics-Consultancy Center Mladost M Varna OOD
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VarnaBulgariaRecruiting
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BrasíliaBrazilNot yet recruiting
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CampinasBrazilNot yet recruiting
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CuritibaBrazilNot yet recruiting
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CuritibaBrazilNot yet recruiting
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Porto AlegreBrazilNot yet recruiting
Hospital Moinhos de Vento
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Porto AlegreBrazilRecruiting
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Rio de JaneiroBrazilNot yet recruiting
CPQuali Pesquisa Clínica
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São PauloBrazilRecruiting
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São PauloBrazilNot yet recruiting
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HamiltonCanadaNot yet recruiting
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LondonCanadaNot yet recruiting
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TorontoCanadaNot yet recruiting
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TorontoCanadaNot yet recruiting
Ontario Shores Centre for Mental Health Sciences
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WhitbyCanadaRecruiting
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AntofagastaChileNot yet recruiting
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SantiagoChileNot yet recruiting
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SantiagoChileNot yet recruiting
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Viña del MarChileNot yet recruiting
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VitacuraChileNot yet recruiting
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BeijingChinaNot yet recruiting
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BeijingChinaNot yet recruiting
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ChangshaChinaNot yet recruiting
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GuangzhouChinaNot yet recruiting
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GuangzhouChinaNot yet recruiting
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Haidian DistrictChinaNot yet recruiting
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HangzhouChinaNot yet recruiting
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HangzhouChinaNot yet recruiting
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KunmingChinaNot yet recruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
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ShenzhenChinaNot yet recruiting
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TianjinChinaNot yet recruiting
Neuro Health Centrum s.r.o.
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Brno-LíšeňCzechiaRecruiting
NEUROHK s r o
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ChoceňCzechiaRecruiting
AGE Centrum s.r.o.
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OlomoucCzechiaRecruiting
A-Shine s.r.o.
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Plzen 3CzechiaRecruiting
INEP medical s.r.o.
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PragueCzechiaRecruiting
Neuropsychiatrie s.r.o.
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Prague 6CzechiaRecruiting
Vestra Clinics s.r.o.
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Rychnov nad KněžnouCzechiaRecruiting
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DüsseldorfGermanyNot yet recruiting
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HalleGermanyNot yet recruiting
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WesterstedeGermanyNot yet recruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Oroitu S.L.
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GetxoSpainRecruiting
Hospital Ruber Juan Bravo
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Hospital Victoria Eugenia De La Cruz Roja Espanola
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SevillaSpainRecruiting
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainRecruiting
Hospital Universitario Rio Hortega
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ValladolidSpainRecruiting
Clinica Montecanal S.L.
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ZaragozaSpainRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Les Hopitaux Universitaires de Strasbourg
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StrasbourgFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Hospices Civils De Lyon
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VilleurbanneFranceRecruiting
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CambridgeUnited KingdomNot yet recruiting
Surrey and Borders Partnership NHS Foundation Trust
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ChertseyUnited KingdomRecruiting
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LondonUnited KingdomNot yet recruiting
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LondonUnited KingdomNot yet recruiting
NeuroClin Glasgow
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MotherwellUnited KingdomRecruiting
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PrestonUnited KingdomNot yet recruiting
Cornwall Partnership NHS Foundation Trust
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RedruthUnited KingdomRecruiting
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SheffieldUnited KingdomNot yet recruiting
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StaffordUnited KingdomWithdrawn
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WolverhamptonUnited KingdomNot yet recruiting
Henry Dunant Hospital Center
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AthensGreeceNot yet recruiting
University General Hospital Attikon
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AthensGreeceNot yet recruiting
Eginitio Hospital
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AthensGreeceNot yet recruiting
University General Hospital of Ioannina
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IoanninaGreeceNot yet recruiting
Athens Medical Center S.A.
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MaroussiGreeceNot yet recruiting
General University Hospital Of Patras
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PatrasGreeceNot yet recruiting
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceNot yet recruiting
Klinika za psihijatriju Vrapce
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Grad ZagrebCroatiaNot yet recruiting
KBC Zagreb
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Grad ZagrebCroatiaNot yet recruiting
Clinical Hospital Centre Rijeka
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RijekaCroatiaNot yet recruiting
KBC Split
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SplitCroatiaNot yet recruiting
Opca Bolnica Varazdin
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VarazdinCroatiaNot yet recruiting
Poliklinika Bonifarm
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ZagrebCroatiaNot yet recruiting
Semmelweis University
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BudapestHungaryNot yet recruiting
Clinexpert Kft.
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Budapest IIIHungaryNot yet recruiting
University of Debrecen
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DebrecenHungaryNot yet recruiting
Obudai Egeszseguegyi Centrum Kft.
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DunaujvarosHungaryNot yet recruiting
Gyoengyosi Bugat Pal Koerhaz
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GyongyosHungaryNot yet recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryNot yet recruiting
Dr. Mathe Es Tarsa Bt.
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KalocsaHungaryNot yet recruiting
Sanz MC, Laniado Hospital
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NetanyaIsraelRecruiting
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Petch TikvaIsraelNot yet recruiting
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Ramat GanIsraelNot yet recruiting
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Ramat GanIsraelNot yet recruiting
Bayit Balev Ltd.
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Rishon Le'TzionIsraelRecruiting
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AhmedabadIndiaNot yet recruiting
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DelhiIndiaNot yet recruiting
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HyderabadIndiaNot yet recruiting
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HyderabadIndiaNot yet recruiting
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KolkataIndiaNot yet recruiting
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New DelhiIndiaNot yet recruiting
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VaranasiIndiaNot yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Istituto Auxologico Italiano
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Nippon Medical School Hospital
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Bunkyo-kuJapanRecruiting
Kuramitsu Hospital
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FukuokaJapanRecruiting
Hatano Kousei Hospital
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HadanoJapanRecruiting
National Hospital Organization Hizen Psychiatric Center
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Kanzaki-Gun Yoshinogari-ChoJapanRecruiting
Rainbow and Sea Hospital
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Karatsu-shiJapanRecruiting
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KawasakiJapanNot yet recruiting
Okayama City General Medical Center Okayama City Hospital
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OkayamaJapanRecruiting
Asakayama Hospital
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SakaiJapanRecruiting
Jichi Medical University Hospital
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Shimotsuke-shi, TochigiJapanRecruiting
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DeaguSouth KoreaNot yet recruiting
Inha University Hospital
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IncheonSouth KoreaRecruiting
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IncheonSouth KoreaNot yet recruiting
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SeoulSouth KoreaNot yet recruiting
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SeoulSouth KoreaWithdrawn
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
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SeoulSouth KoreaNot yet recruiting
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SeoulSouth KoreaNot yet recruiting
The Catholic University of Korea Yeouido St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Gangnam Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Boca Clinical Trials Mexico S.C.
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GuadalajaraMexicoRecruiting
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Mexico CityMexicoNot yet recruiting
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Mexico CityMexicoNot yet recruiting
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Mexico CityMexicoNot yet recruiting
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MonterreyMexicoNot yet recruiting
AVIX Investigacion Clinica
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MonterreyMexicoRecruiting
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SaltilloMexicoNot yet recruiting
Neurociencias PRISMA A.C.
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San Luis Potosí CityMexicoRecruiting
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TlalnepantlaMexicoNot yet recruiting
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandRecruiting
M2M Med. Sp. z o.o. Sp. j.
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ChorzowPolandRecruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandRecruiting
Centrum In Psyche Spersonalizowanej Psychiatrii i Terapii
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KatowicePolandRecruiting
Centrum Medyczne HCP Sp. z o.o.
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PoznanPolandRecruiting
RCMed Oddzial Sochaczew
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SochaczewPolandRecruiting
Wrocławskie Centrum Alzheimerowskie
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WrocławPolandRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalNot yet recruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalNot yet recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalNot yet recruiting
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalNot yet recruiting
CNS Saude Lda.
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Torres VedrasPortugalNot yet recruiting
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
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BrasovRomaniaNot yet recruiting
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
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BucharestRomaniaNot yet recruiting
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
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BucharestRomaniaNot yet recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
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BucharestRomaniaNot yet recruiting
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
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BucurestiRomaniaNot yet recruiting
Spitalul Clinic Cai Ferate Constanta
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ConstanțaRomaniaNot yet recruiting
Institutul De Psihiatrie Socola Iasi
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JassiRomaniaNot yet recruiting
Spitalul Clinic De Psihiatrie Dr. Gheorghe Preda Sibiu
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SibiuRomaniaNot yet recruiting
Aria Clinic S.R.L.
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SibiuRomaniaNot yet recruiting
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Kaohsiung Niao Sung DistTaiwanNot yet recruiting
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Tainan, TaianaTaiwanNot yet recruiting
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TaipeiTaiwanNot yet recruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
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TaoyuanTaiwanNot yet recruiting
MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
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DniproUkraineRecruiting
Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
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HlevakhaUkraineRecruiting
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HlevakhaUkraineNot yet recruiting
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
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KropyvnytskyiUkraineRecruiting
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KyivUkraineNot yet recruiting
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KyivUkraineNot yet recruiting
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LvivUkraineNot yet recruiting
COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
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LvivUkraineRecruiting
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LvivUkraineNot yet recruiting
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
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OleksandrivkaUkraineRecruiting
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
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PoltavaUkraineRecruiting
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
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SkarzhyntsiUkraineRecruiting
Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
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SmilaUkraineRecruiting
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TernopilUkraineNot yet recruiting
Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
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VinnytsiaUkraineRecruiting
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AnaheimUnited StatesNot yet recruiting
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AtlantaUnited StatesNot yet recruiting
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BenningtonUnited StatesNot yet recruiting
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Blue AshUnited StatesNot yet recruiting
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Bonita SpringsUnited StatesNot yet recruiting
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BountifulUnited StatesCompleted
Epic Medical Research, LLC - Carrolton
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CarrolltonUnited StatesRecruiting
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ChandlerUnited StatesNot yet recruiting
Horizon Clinical Research Center - Houston
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CypressUnited StatesRecruiting
Advanced Neurology Epilepsy and Sleep Center
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El PasoUnited StatesRecruiting
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FresnoUnited StatesNot yet recruiting
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GaithersburgUnited StatesNot yet recruiting
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HattiesburgUnited StatesNot yet recruiting
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Las VegasUnited StatesNot yet recruiting
Redbird Research
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Las VegasUnited StatesRecruiting
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Long BeachUnited StatesNot yet recruiting
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Long BeachUnited StatesNot yet recruiting
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MesquiteUnited StatesNot yet recruiting
Nuovida Research Center
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MiamiUnited StatesRecruiting
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MilwaukeeUnited StatesNot yet recruiting
West Clinical Research
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Morehead CityUnited StatesRecruiting
Boston Center for Memory
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NewtonUnited StatesRecruiting
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New WindsorUnited StatesNot yet recruiting
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OrangeUnited StatesNot yet recruiting
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OrlandoUnited StatesNot yet recruiting
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PasadenaUnited StatesNot yet recruiting
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PomonaUnited StatesNot yet recruiting
Progressive Medical Research
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Port OrangeUnited StatesRecruiting
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PrincetonUnited StatesNot yet recruiting
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Saint PaulUnited StatesNot yet recruiting
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San AntonioUnited StatesNot yet recruiting
Imaging Endpoints
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ScottsdaleUnited StatesRecruiting
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SeattleUnited StatesNot yet recruiting
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Staten IslandUnited StatesNot yet recruiting
IPTB Clinical Research
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TampaUnited StatesRecruiting
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TorranceUnited StatesNot yet recruiting
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TroyUnited StatesNot yet recruiting
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TulsaUnited StatesNot yet recruiting
Hope Research Network - Miami
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Virginia GardensUnited StatesRecruiting
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Walnut CreekUnited StatesNot yet recruiting
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WoodmereUnited StatesNot yet recruiting
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WorcesterUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.