Hope for Alzheimer's agitation: new drug combo enters final testing

NCT ID NCT07011745

Recruiting now Symptom relief Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether a combination of two drugs, KarXT and KarX-EC, can safely reduce agitation in people with Alzheimer's disease. About 352 adults with Alzheimer's-related agitation will receive either the drug combo or a placebo for 14 weeks. The main goal is to see if agitation scores improve more with the active treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Xanomeline/Trospium Chloride (KarXT) and Xanomeline Enteric Capsule (KarX-EC)

What this could lead to

If it works, this could provide a new option to calm agitation in people with Alzheimer's, improving their quality of life and reducing caregiver burden.

What could go wrong

This is a phase 3 trial, but it's still experimental. The drug may not work better than a placebo, and side effects like gastrointestinal issues or dizziness are possible.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALZHEIMER DISEASE

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••
Contact

Locations

"Medical Centre "Neuroclinic" LLC
RECRUITING

Lviv, 79035, Ukraine

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A-SHINE s.r.o.
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Pilsen, 301 00, Czechia

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AGE Centrum
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Olomouc, Olomouc Region, 779 00, Czechia

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Accellacare
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Long Beach, California, 90807, United States

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Agile Clinical Research Trials, LLC
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Atlanta, Georgia, 30328, United States

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Asan Medical Center
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Seoul, 05505, South Korea

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Auxologico IRCCS - Auxologico San Luca
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Milan, Lombardy, 20149, Italy

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Azienda Ospedaliera Spedali Civili di Brescia
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Brescia, 25123, Italy

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Azienda Ospedaliero Universitaria Pisana
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Pisa, PI, 56126, Italy

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Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155
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Rome, Lazio, 00185, Italy

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Azienda Ospedaliero-Universitaria Sant'Andrea
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Rome, Lazio, 00189, Italy

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Bayit Balev Ltd.
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Rishon Le'Tzion, 7590653, Israel

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Black Country Healthcare NHS Foundation Trust
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Wolverhampton, WV4 5HN, United Kingdom

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CNCE "Cherkasy regional psychiatric hospital of Cherkasy regional council"
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Smila, Cherkasy Oblast, 20708, Ukraine

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CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)
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Kyiv, 04080, Ukraine

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CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)"
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Hlevakha, 08631, Ukraine

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COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
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Lviv, Lviv Oblast, 79021, Ukraine

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Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
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Lille, 59037, France

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Centre Hospitalier Universitaire Toulouse - Cité de la Santé
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Toulouse, Haute-Garonne, 31000, France

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Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
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Limoges, 87042, France

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Centres Memoire de Ressources et de Recherche (CMRR) - Hopital Lariboisiere-Fernand-Widal Location
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Paris, 75010, France

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Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1058, Argentina

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Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii
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Katowice, 40-146, Poland

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Centrum Medyczne HCP Szpital im. Jana Pawla II
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Poznan, Greater Poland Voivodeship, 61-485, Poland

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Centrum Medyczne NEUROMED
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

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Chandler Clinical Trials, LLC
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Chandler, Arizona, 85224, United States

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Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
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Poltava, 36013, Ukraine

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Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
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Kropyvnytskyi, 25491, Ukraine

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Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
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Hlevakha, Kyiv Oblast, 08631, Ukraine

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Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
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Vinnytsia, Vinnytsia Oblast, 21037, Ukraine

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Cornwall Partnership NHS Foundation Trust
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Redruth, TR15 3QE, United Kingdom

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Envision Trials LLC
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Bonita Springs, Florida, 34134-4154, United States

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Epic Medical Research, LLC - Carrolton
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Carrollton, Texas, 75006, United States

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Epic Medical Research, LLC - Mesquite
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Mesquite, Texas, 75150, United States

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EvergreenHealth Medical Center
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Kirkland, Washington, 98034, United States

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Fondazione Policlinico Gemelli IRCCS
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Roma, 00168, Italy

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Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM
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Buenos Aires, 1133, Argentina

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Gachon University Gil Medical Center
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Incheon, 405-760, South Korea

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Gangnam Severance Hospital, Yonsei University Health System
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Seoul, 06273, South Korea

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Hattiesburg Clinic
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Hattiesburg, Mississippi, 39402, United States

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Hopital Gui Chauliac - Chu Montpellier
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Montpellier, 34295, France

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Horizon Clinical Research Center - Houston
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Cypress, Texas, 77065, United States

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Hôpital des Charpennes - Hospices Civils de Lyon (HCL)
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Villeurbanne, Rhône, 69100, France

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IPTB Clinical Research
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Tampa, Florida, 33629, United States

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Inha University Hospital
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Incheon, Incheon Gwang'yeogsi, 22332, South Korea

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Institut neuropsychiatricke pece (INEP), Praha
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Prague, Praha 8, 18600, Czechia

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Instituto De Neurologia Dra. Ivonne Fraga
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San Juan, 00918, Puerto Rico

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Instituto Modelo de Neurología, Fundación Lennox
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Córdoba, 5000, Argentina

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Instituto Médico DAMIC
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Córdoba, X5003DCE, Argentina

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Key Clinical Research
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Bradenton, Florida, 34207, United States

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Konkuk University Medical Center
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Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea

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Kyungpook National University Chilgok Hospital
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Deagu, Taegu-Kwangyǒkshi, 41404, South Korea

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Lancashire & South Cumbria NHS Foundation Trust
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Preston, Lancashire, PR2 9HT, United Kingdom

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Las Vegas Clinical Trials
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Las Vegas, Nevada, 89030, United States

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Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
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Strasbourg, 67091, France

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Local Institution - 2002
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Córdoba, 5000, Argentina

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Buenos Aires, 1199, Argentina

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Local Institution - 2050
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Santiago, Santiago Metropolitan, 7560356, Chile

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Local Institution - 2051
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Santiago, Santiago Metropolitan, 7500710, Chile

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Local Institution - 2052
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Santiago, Santiago Metropolitan, 8330024, Chile

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Local Institution - 2053
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Antofagasta, 1270244, Chile

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Local Institution - 2054
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Vitacura, Santiago Metropolitan, 2511433, Chile

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Local Institution - 2055
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Viña del Mar, Valparaiso, 2511433, Chile

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Local Institution - 2102
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Prague, 100 000, Czechia
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Prague, 100 00, Czechia
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Düsseldorf, 40221, Germany

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Local Institution - 2205
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Halle, 06120, Germany

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Local Institution - 2206
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Westerstede, 26655, Germany

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Local Institution - 2250
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Győr, Győr-Moson-Sopron, 0, Hungary

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Budapest, 1083, Hungary
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Debrecen, 4032, Hungary

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Local Institution - 2254
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Gyöngyös, Heves County, 3200, Hungary

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Local Institution - 2255
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Budapest, 1036, Hungary

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Local Institution - 2256
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Budapest, 1033, Hungary

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Kalocsa, Bács-Kiskun county, 6300, Hungary

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Local Institution - 2302
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Petch Tikva, IL, 49100, Israel

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Local Institution - 2355
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Isernia, 86077, Italy
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Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 2451
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Lublin, 20-064, Poland
Local Institution - 2452
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Lublin, 20-064, Poland
Local Institution - 2457
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Wroclaw, 53-659, Poland

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Local Institution - 2458
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Krakow, 31-505, Poland

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Local Institution - 2500
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London, W12 0NN, United Kingdom

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Local Institution - 2502
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Cambridge, CB21 5EF, United Kingdom

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Local Institution - 2509
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Stafford, ST16 3SR, United Kingdom
Local Institution - 2560
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Lutsk, Volyn Oblast, 43005, Ukraine

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Local Institution - 2562
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Ternopil, 46027, Ukraine

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Local Institution - 2565
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Kyiv, 01030, Ukraine

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Local Institution - 2569
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Lviv, 79035, Ukraine

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Local Institution - 2601
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Basalt, Colorado, 81621, United States
Local Institution - 2603
COMPLETED

Ozark, Missouri, 65721, United States
Local Institution - 2606
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Homestead, Florida, 33032, United States

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Local Institution - 2607
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Long Beach, California, 90805, United States

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Local Institution - 2610
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Milwaukee, Wisconsin, 53226, United States

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Local Institution - 2612
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Bountiful, Utah, 84010, United States
Local Institution - 2613
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Pasadena, California, 91105, United States

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Local Institution - 2614
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San Diego, California, 92108, United States

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Local Institution - 2618
ACTIVE_NOT_RECRUITING

Ann Arbor, Michigan, 48105, United States
Local Institution - 2620
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West Hills, California, 91307, United States
Local Institution - 2627
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Napa, California, 94558, United States

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Local Institution - 2630
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Saint Paul, Minnesota, 55130, United States

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Local Institution - 2631
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Chandler, Arizona, 85226-3732, United States

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Local Institution - 2632
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Norwalk, Connecticut, 06851, United States

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Local Institution - 2633
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Miami, Florida, 33137, United States

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Local Institution - 2634
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Orlando, Florida, 32806, United States

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Local Institution - 2635
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Colorado Springs, Colorado, 80907, United States

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Local Institution - 2636
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Doral, Florida, 33122, United States

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Local Institution - 2637
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Miami, Florida, 33165, United States

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Local Institution - 2639
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San Juan, 00918, Puerto Rico

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Local Institution - 2641
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San Juan, 00917, Puerto Rico

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Local Institution - 2645
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San Juan, 00918, Puerto Rico

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Local Institution - 2646
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Chandler, Arizona, 85286, United States

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Local Institution - 2647
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Brooklyn, New York, 11229, United States

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Local Institution - 2648
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Aventura, Florida, 33180, United States

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Local Institution - 2649
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Orange, California, 92866, United States

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Local Institution - 2650
NOT_YET_RECRUITING

Toms River, New Jersey, 08755, United States

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M2M Med
RECRUITING

Chorzów, 41-500, Poland

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MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
RECRUITING

Dnipro, Dnipropetrovsk Oblast, 49115, Ukraine

Contact Phone: •••-•••-••••
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
RECRUITING

Skarzhyntsi, Khmelnytskyi Oblast, 32120, Ukraine

Contact Phone: •••-•••-••••
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
RECRUITING

Oleksandrivka, Odesa Oblast, 67513, Ukraine

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NEUROHK
RECRUITING

Choceň, 565 01, Czechia

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National Institute of Clinical Research
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Garden Grove, California, 92844, United States

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Neuro Health Centrum s.r.o.
RECRUITING

Brno, South Moravian, 628 00, Czechia

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NeuroClin Glasgow
RECRUITING

Motherwell, ML1 4UF, United Kingdom

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Neuropsychiatrie
RECRUITING

Prague, Praha 6, 160 00, Czechia

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RCMed Oddzial Sochaczew
RECRUITING

Sochaczew, 96-500, Poland

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Resolution Psychopharmacology Research Institute
RECRUITING

Mendoza, 5502, Argentina

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Richmond Behavioral Associates
RECRUITING

Staten Island, New York, 10312, United States

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SMG-SNU Borame Medical Center
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Seoul, 07061, South Korea

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Sanz MC, Laniado Hospital
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Netanya, 4244916, Israel

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Semmelweis Egyetem
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Budapest, 1083, Hungary

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Seoul National University Hospital
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Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

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Sheffield Health and Social care NHS Foundation Trust
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Sheffield, S5 7JT, United Kingdom

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South London and Maudsley NHS Foundation Trust
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London, SE5 8AZ, United Kingdom

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Surrey and Borders Partnership NHS Foundation Trust
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Chertsey, Surrey, KT16 9AU, United Kingdom

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The Catholic University of Korea, Yeouido St.Mary's Hospital
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Seoul, 07345, South Korea

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The Chaim Sheba Medical Center
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Ramat Gan, Central District, 5262000, Israel

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The Israeli Alzheimer Medical Center
RECRUITING

Ramat Gan, 5265601, Israel

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UT Health - San Antonio
RECRUITING

San Antonio, Texas, 78229, United States

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University of Naples Federico II
RECRUITING

Naples, Campania, 80131, Italy

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Velocity Clinical Research - Blue Ash
RECRUITING

Blue Ash, Ohio, 45242, United States

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Vestra Clinics s.r.o.
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Rychnov nad Kněžnou, 516 01, Czechia

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Vitalix Clinical
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Worcester, Massachusetts, 01608, United States

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Walnut Clinical Research
RECRUITING

Valley Stream, New York, 11580, United States

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West Clinical Research
RECRUITING

Morehead City, North Carolina, 28557, United States

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