A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Last updated: April 2, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Dementia

Memory Problems

Mental Disability

Treatment

Trontinemab

Placebo

Clinical Study ID

NCT07169578
WN45443
2024-518006-40-00
  • Ages 50-90
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment [MCI] to mild dementia due to AD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willingness and ability to complete all aspects of the study (including MRI,clinical genotyping, and PET imaging or CSF as applicable) for the duration of thestudy. The participant should be capable of completing assessments either alone orwith the help of the study partner

  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient toperform the neuropsychological testing (eyewear and hearing aids are permitted)

  • Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSFtau181/Aβ42 ratio may be used as an alternative option if amyloid PET is notavailable

  • Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinicalsyndrome clinical Stage 3 or Stage 4

  • Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0

  • Participant- and/or Informant-reported history of cognitive decline with gradualonset and progression over the last 1 year before screening

  • A Repeatable Battery for the Assessment of Neuropsychological Status Delayed MemoryIndex (RBANS DMI) score of 85 or order

  • Availability of a "study partner" as defined by the protocol

Exclusion

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition

  • History or presence of clinically significant cerebrovascular disease

  • History of severe, clinically significant (persistent neurologic deficit orstructural brain damage) central nervous system (CNS) trauma

  • History or presence of clinically significant intracranial mass

  • MRI evidence of significant cerebral abnormalities or inability to tolerate MRIprocedures or contraindication to MRI

  • Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) whichare not stable and adequately controlled or which in the opinion of the investigatorcould affect the participant's safety in the study or interfere with the studyassessments

  • History of malignancy with the following exceptions: if considered to be cured;malignancies with a negligible risk of metastasis or death

Study Design

Total Participants: 800
Treatment Group(s): 2
Primary Treatment: Trontinemab
Phase: 3
Study Start date:
September 17, 2025
Estimated Completion Date:
June 07, 2028

Connect with a study center

  • Centro de Pesquisas Clinicas - CPCLIN

    São Paulo, São Paulo 01228-200
    Brazil

    Active - Recruiting

  • Richmond Clinical Trials

    Richmond, British Columbia V6V 2L1
    Canada

    Active - Recruiting

  • Richmond Clinical Trials

    Richmond 6122085, British Columbia 5909050 V6V 2L1
    Canada

    Site Not Available

  • Baycrest Academy for Research and Education

    North YORK, Ontario M6A 2E1
    Canada

    Active - Recruiting

  • Centricity East York

    Toronto, Ontario M4G 3E8
    Canada

    Active - Recruiting

  • Toronto Memory Program

    Toronto, Ontario M3B 2S7
    Canada

    Active - Recruiting

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

  • Toronto Memory Program

    Toronto 6167865, Ontario 6093943 M3B 2S7
    Canada

    Site Not Available

  • Clinique Memoire de Montreal

    Montreal, Quebec H2X 3B9
    Canada

    Active - Recruiting

  • Clinique Memoire de Montreal

    Montreal 6077243, Quebec 6115047 H2X 3B9
    Canada

    Site Not Available

  • Alpha Recherche Clinique

    Québec, G3K 2P8
    Canada

    Active - Recruiting

  • Alpha Recherche Clinique

    Québec 6325494, G3K 2P8
    Canada

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221002
    China

    Active - Recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality 200127
    China

    Active - Recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200127
    China

    Site Not Available

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050
    China

    Active - Recruiting

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, 100050
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, 100034
    China

    Active - Recruiting

  • Peking University Sixth Hospital

    Beijing, 100083
    China

    Active - Recruiting

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing 1816670, 100050
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670, 100034
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun 2038180, 130021
    China

    Site Not Available

  • West China Hospital - Sichuan University

    Chengdu, 610047
    China

    Active - Recruiting

  • West China Hospital - Sichuan University

    Chengdu 1815286, 610047
    China

    Site Not Available

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016
    China

    Active - Recruiting

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing 1814906, 400016
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, 350001
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, 510030
    China

    Active - Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260
    China

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  • Guangdong General Hospital

    Guangzhou 1809858, 510030
    China

    Site Not Available

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou 1809858, 510260
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016
    China

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  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou 1808926, 310016
    China

    Site Not Available

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    Hefei, 230088
    China

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  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022
    China

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  • Anhui Provincial Hospital

    Hefei 1808722, 230088
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei 1808722, 230022
    China

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  • Nanjing Brain Hospital

    Nanjing, 210029
    China

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  • Nanjing First Hospital

    Nanjing, 210029
    China

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  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, 210009
    China

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  • Nanjing Brain Hospital

    Nanjing 1799962, 210029
    China

    Site Not Available

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    Nanjing 1799962, 210029
    China

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  • Zhongda Hospital Affiliated to Southeast University

    Nanjing 1799962, 210009
    China

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  • Huashan Hospital, Fudan University

    Shanghai, 200040
    China

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    Shanghai, 200025
    China

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    Shanghai, 200080
    China

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    Shanghai, 201399
    China

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    Shanghai, 200233
    China

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  • Huashan Hospital, Fudan University

    Shanghai 1796236, 200040
    China

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  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai 1796236, 200025
    China

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  • Shanghai First People's Hospital

    Shanghai 1796236, 200080
    China

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  • Shanghai Pudong Hospital

    Shanghai 1796236, 201399
    China

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  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004
    China

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  • The Second Affiliated Hospital of Soochow University

    Suzhou 1886760, 215004
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

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  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou 10630003, 221006
    China

    Site Not Available

  • Hôpital Broca

    Le Kremlin Bicétre Cedex, 94275
    France

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    Lille, 59037
    France

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    Lille 2998324, 59037
    France

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    Marseille, 13385
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    Marseille 2995469, 13385
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    Paris, 75475
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    Paris 2988507, 75475
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    Rennes, 35033
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    Rennes 2983990, 35033
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    Toulouse, 31059
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    Toulouse 2972315, 31059
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    Tours, 37000
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    Tours 2972191, 37000
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    Vandœuvre-lès-Nancy, 54500
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    Villeurbanne, 69100
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  • Hopital des Charpennes

    Villeurbanne 2968254, 69100
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  • Uniklinik RWTH Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

  • Uniklinik RWTH Aachen

    Aachen 3247449, 52074
    Germany

    Site Not Available

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg, 61348
    Germany

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  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg 2953436, 61348
    Germany

    Site Not Available

  • Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie

    Bayreuth, 95445
    Germany

    Active - Recruiting

  • Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie

    Bayreuth 2951825, 95445
    Germany

    Site Not Available

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791
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  • St. Josef-Hospital, Klinik für Neurologie

    Bochum 2947416, 44791
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    Site Not Available

  • Gesundheit Nord, Klinikum Bremen-Ost

    Bremen, 28325
    Germany

    Active - Recruiting

  • Gesundheit Nord, Klinikum Bremen-Ost

    Bremen 2944388, 28325
    Germany

    Site Not Available

  • NeuroCentrum Odenwald

    Erbach/Odenwald, 64711
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106
    Germany

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  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau 2925177, 79106
    Germany

    Site Not Available

  • MVZ Rheumatologie und Autoimummedizin Hamburg GmbH

    Hamburg, 20095
    Germany

    Active - Recruiting

  • MVZ Rheumatologie und Autoimummedizin Hamburg GmbH

    Hamburg 2911298, 20095
    Germany

    Site Not Available

  • Neurology UKSH Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München

    München, 81675
    Germany

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  • Klinikum rechts der Isar der TU München

    München 2867711, 81675
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann

    Steglitz, 12163
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann

    Steglitz 2829109, 12163
    Germany

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  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292
    Germany

    Active - Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier 2821164, 54292
    Germany

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  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

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  • Universitätsklinikum Ulm

    Ulm 2820256, 89081
    Germany

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  • Fondazione Santa Lucia IRCCS

    Rome, Lazio 00179
    Italy

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  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio 00185
    Italy

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  • Fondazione Santa Lucia IRCCS

    Rome 3169070, Lazio 3174976 00179
    Italy

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  • Azienda Ospedaliero Universitaria San Martino

    Genoa, Liguria 16132
    Italy

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  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy 25123
    Italy

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  • IRCCS Ospedale San Raffaele

    Milan, Lombardy 20132
    Italy

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  • IRCCS Ospedale San Raffaele

    Milan 3173435, Lombardy 3174618 20132
    Italy

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  • Kyoto University Hospital

    Kyoto, 606-8507
    Japan

    Active - Recruiting

  • National Hospital Organization Utano National Hospital

    Kyoto, 616-8255
    Japan

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  • National Hospital Organization Utano National Hospital

    Kyoto 1857910, 616-8255
    Japan

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  • Mishuku Hospital

    Meguro-Ku, 153-0051
    Japan

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  • Mie University Hospital

    Mie, 514-8507
    Japan

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  • Mie University Hospital

    Mie 1857357, 514-8507
    Japan

    Site Not Available

  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

    Tokyo, 190-8531
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo, 160-8582
    Japan

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  • Memory Clinic Ochanomizu

    Tokyo, 113-0034
    Japan

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  • National Center of Neurology and Psychiatry

    Tokyo, 187-8551
    Japan

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  • P-One Clinic

    Tokyo, 192-0071
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Geriatric Hospital

    Tokyo, 173-0015
    Japan

    Active - Recruiting

  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

    Tokyo 1850147, 190-8531
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo 1850147, 160-8582
    Japan

    Active - Recruiting

  • Memory Clinic Ochanomizu

    Tokyo 1850147, 113-0034
    Japan

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  • National Center of Neurology and Psychiatry

    Tokyo 1850147, 187-8551
    Japan

    Active - Recruiting

  • P-One Clinic

    Tokyo 1850147, 192-0071
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Geriatric Hospital

    Tokyo 1850147, 173-0015
    Japan

    Site Not Available

  • Yamagata Tokusyukai Hospital

    Yamagata, 990-0834
    Japan

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  • Yamagata Tokusyukai Hospital

    Yamagata 2110556, 990-0834
    Japan

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  • Centrum Medyczne Neuromed Sp. z.o.o.

    Bydgoszcz, 85-163
    Poland

    Active - Recruiting

  • Centrum Medyczne Neuromed Sp. z.o.o.

    Bydgoszcz 3102014, 85-163
    Poland

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  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice, 40-749
    Poland

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  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice 3096472, 40-749
    Poland

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  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

    Krakow, 31-505
    Poland

    Active - Recruiting

  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

    Lublin, 20-410
    Poland

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  • Nmedis sp. z o.o.

    Rzeszów, 35-323
    Poland

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  • Centrum Leczenia Zaburzen Pamieci

    Warsaw, 03-839
    Poland

    Active - Recruiting

  • ETG Neuroscience Sp. z o.o.

    Warsaw, 02-677
    Poland

    Active - Recruiting

  • Centrum Leczenia Zaburzen Pamieci

    Warsaw 756135, 03-839
    Poland

    Site Not Available

  • ETG Neuroscience Sp. z o.o.

    Warsaw 756135, 02-677
    Poland

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  • NZOZ WCA

    Wroc?aw, 53-659
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  • SPSK nr 1

    Zabrze, 41-800
    Poland

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  • SPSK nr 1

    Zabrze 3080985, 41-800
    Poland

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  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona 8195
    Spain

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  • Hospital General De Catalunya

    Sant Cugat del Vallès 3110718, Barcelona 8195
    Spain

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  • Hospital Mutua De Terrasa

    Terrassa, Barcelona 08222
    Spain

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  • Policlínica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa 20014
    Spain

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  • Policlínica Guipuzcoa

    Donostia / San Sebastian 3110044, Guipuzcoa 20014
    Spain

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    Lleida, Lerida 25198
    Spain

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  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid 28223
    Spain

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  • Hospital Quiron de Madrid

    Pozuelo de Alarcón 3112989, Madrid 3117732 28223
    Spain

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    Córdoba, 14004
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    Córdoba 2519240, 14004
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    Madrid, 28006
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    Valencia, 46017
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    Valencia 2509954, 46017
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  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807
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    Kaohsiung City 1673820, 807
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    New Taipei City, 23561
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    New Taipei City 12908892, 23561
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    North Dist., 40447
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    Taichung, 40705
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    Taichung 1668399, 40705
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    Taipei, 100
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    Taipei, 11217
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    Taipei 1668341, 100
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    Taoyuan, 333
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    Taoyuan 6696918, 333
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    Bradford, BD9 6DP
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    Bradford 2654993, BD9 6DP
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    Bristol, BS32 4SY
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    London, SE5 8AF
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    London 2643743, W6 8RF
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    London 2643743, W1G 8TA
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    York, YO31 8TA
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    Sun City, Arizona 85351
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    Inglewood, California 90301
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    Irvine, California 92614
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    San Francisco, California 94158
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    Santa Ana, California 92705
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    Inglewood 5359488, California 5332921 90301
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    Irvine 5359777, California 5332921 92614
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    San Francisco 5391959, California 5332921 94158
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    Santa Ana 5392900, California 5332921 92705
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    Lady Lake, Florida 32159
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    Maitland, Florida 32751
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    Ocala, Florida 34470
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    Tampa, Florida 33609
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    The Villages, Florida 32162
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    Wellington, Florida 33414
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    Winter Park, Florida 32789
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  • K2 Medical Research - The Villages

    Lady Lake 4161118, Florida 4155751 32159
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    Maitland 4163220, Florida 4155751 32751
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    Ocala 4166673, Florida 4155751 34470
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  • Axiom Brain Health LLC

    Tampa 4174757, Florida 4155751 33609
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    The Villages 4175179, Florida 4155751 32162
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    Wellington 4177703, Florida 4155751 33414
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    Winter Park 4178560, Florida 4155751 32789
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    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Accel Research Sites-NeuroStudies

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Accel Research Sites-NeuroStudies

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu 5856195, Hawaii 5855797 96817
    United States

    Site Not Available

  • RE:Cognition (Chicago)

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • RE:Cognition (Chicago)

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Boston Center for Memory

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

  • Boston Center for Memory

    Newton 4945283, Massachusetts 6254926 02459
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey

    Ridgewood, New Jersey 07450
    United States

    Active - Recruiting

  • The Cognitive and Research Center of New Jersey

    Ridgewood 5103269, New Jersey 5101760 07450
    United States

    Site Not Available

  • Basil Clinical

    Laurelton, New York 11413-2016
    United States

    Active - Recruiting

  • Adams Clinical Harlem

    New York, New York 10029
    United States

    Active - Recruiting

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Active - Recruiting

  • Adams Clinical Bronx

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Basil Clinical

    Laurelton 5124078, New York 5128638 11413-2016
    United States

    Site Not Available

  • Adams Clinical Harlem

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Triad Clinical Trials

    Greensboro, North Carolina 27410
    United States

    Active - Recruiting

  • Triad Clinical Trials

    Greensboro 4469146, North Carolina 4482348 27410
    United States

    Site Not Available

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Genesis Neuroscience Clinic

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • K2 Medical Research - Nashville

    Nashville, Tennessee 37204
    United States

    Active - Recruiting

  • K2 Medical Research - Nashville

    Nashville 4644585, Tennessee 4662168 37204
    United States

    Site Not Available

  • Kerwin Research Center, LLC

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • South Texas Research Institute - Edinburg

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Re:Cognition Health - Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Kerwin Research Center, LLC

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • South Texas Research Institute - Edinburg

    Edinburg 4688275, Texas 4736286 78539
    United States

    Site Not Available

  • Re:Cognition Health - Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia 23294
    United States

    Active - Recruiting

  • National Clinical Research Inc.-Richmond

    Richmond 4781708, Virginia 6254928 23294
    United States

    Site Not Available

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