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Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03444870
Collaborator
(none)
1,016
Enrollment
248
Locations
2
Arms
100.7
Anticipated Duration (Months)
4.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1016 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
Actual Study Start Date :
Jun 6, 2018
Anticipated Primary Completion Date :
Sep 23, 2022
Anticipated Study Completion Date :
Oct 27, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gantenerumab

Gantenerumab will be administered as SC injections with gradual uptitration.

Drug: Gantenerumab
Gantenerumab will be administered as per the schedule specified in the respective arm.
Other Names:
  • RO4909832

    		•
    Placebo Comparator: Placebo

    Placebo will be administered as SC injections with gradual uptitration.

    Drug: Placebo
    Placebo will be administered as per the schedule specified in the respective arm.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to Week 116 in Global Outcome, as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SOB) [Baseline Up to Week 116]

    Secondary Outcome Measures

    1. Change from Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score [Baseline Up to Week 116]

    2. Change from Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) [Baseline Up to Week 116]

    3. Change from Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) [Baseline Up to Week 116]

    4. Change from Baseline to Week 116 in Verbal Fluency Task Score [Baseline Up to Week 116]

    5. Change from Baseline to Week 116 in Coding [Change from baseline to Week 116 in the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) coding subtest.]

    6. Change from Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score [Baseline Up to Week 116]

    7. Change from Baseline to Week 116 in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Total Score [Baseline Up to Week 116]

    8. Percentage of Participants with Adverse Events [Baseline up to end of study (week 164) or Week 35 (Open label extension)]

    9. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [Baseline up to Week 116 or Week 24 in Open label extension]

    10. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [Baseline up to end of study (week 164) or Week 35 (Open label extension)]

    11. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI) [Baseline up to end of study (week 164) or Week 35 (Open label extension)]

    12. Percentage of Participants with Injection-Site Reactions [Baseline up to end of study (week 164) or Week 35 (Open label extension)]

    13. Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab [Baseline up to end of study (week 164) or Week 35 (Open label extension)]

    14. Change from Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a subset of participants up to Week 116 [Baseline Up to Week 116]

    15. Change from Baseline in Brain Tau Load as Measured by Tau PET Scan in a subset of participants up to Week 116 [Baseline Up to Week 116]

    16. Change From Baseline in CSF Marker of Disease in a subset of participants - Total Tau up to Week 116 [Baseline Up to Week 116]

    17. Change From Baseline in CSF Marker of Disease in a subset of participants - Phosphorylated Tau up to Week 116 [Baseline Up to Week 116]

    Other Outcome Measures

    1. Plasma Concentration of Gantenerumab Administered SC [Baseline, Week 2, 24, 41, 52, 76, 103, 115, 128, 164 and at early termination and unscheduled visit, Week 1 and Week 24 (Open label extension)]

      Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion criteria:

    • Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)

    • Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid PET scan

    • Demonstrated abnormal memory function

    • MMSE score greater than or equal to 22 (≥ 22)

    • Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0

    • Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study

    • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening and until randomization

    • For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry

    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods

    Key Exclusion criteria:

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

    • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder

    • History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function

    • History or presence of clinically evident cerebrovascular disease

    • History or presence of posterior reversible encephalopathy syndrome

    • History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack

    • History of severe, clinically significant CNS trauma

    • History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition

    • Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae

    • History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits

    • At risk for suicide in the opinion of the investigator

    • Alcohol and/or substance abuse or dependants in past 2 years

    • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

    • Any contraindications to brain MRI

    • Unstable or clinically significant cardiovascular, kidney or liver disease

    • Uncontrolled hypertension

    • Unstable or clinically significant cardiovascular disease

    • Abnormal thyroid function

    • Patients with evidence of folic acid deficiency

    Exclusion for Open-Label Extension (OLE):

    • Discontinued from study treatment during the double-blind treatment period

    • Received any other investigational medication during the double-blind treatment period or after the end of double-blind treatment

    • Participation in the OLE deemed inappropriate by the investigator

    • Presence of ARIA-E findings at the Week 116 MRI scan

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Neurosciences Tucson Arizona United States 85718
    2 CITrials, Inc. Bellflower California United States 90706
    3 Global Clinical Trials; Irvine, CA Irvine California United States 92614
    4 Excell Research Oceanside California United States 92056
    5 ASCLEPES Research Centers Panorama City California United States 91402
    6 CITrials, Inc. Riverside California United States 92506
    7 Sutter Medical Group, Neurology Sacramento California United States 95816
    8 University of California, Davis; Alzheimers Disease Center, Department of Neurology Sacramento California United States 95817
    9 Syrentis Clinical Research Santa Ana California United States 92705
    10 North Bay Neuro Science Institute Sebastopol California United States 95472
    11 California Neuroscience Research Medical Group, Inc Sherman Oaks California United States 91403
    12 Upland Clinical Research Upland California United States 91789
    13 Coastal Connecticut Research, Llc New London Connecticut United States 06320
    14 Research Center for Clinical Studies, Inc. Norwalk Connecticut United States 06851
    15 Comprehensive Psychiatric Care Norwich Connecticut United States 06360
    16 JEM Research LLC Atlantis Florida United States 33462
    17 Bradenton Research Center Bradenton Florida United States 34205
    18 Clinical Research of South Florida Coral Gables Florida United States 33134
    19 Brain Matters Research, Inc. Delray Beach Florida United States 33445
    20 SIH Research Kissimmee Florida United States 34759
    21 Combined Research Orlando Phase I-IV Orlando Florida United States 32807
    22 Global Medical Institues, LLC; Central Miami Medical Institute South Miami Florida United States 33143
    23 Alzheimer's Research and Treatment Center Wellington Florida United States 33414
    24 Atlanta Center For Medical Research Atlanta Georgia United States 30331
    25 Columbus Memory Center Columbus Georgia United States 31909
    26 Center for Advanced Research & Education Gainesville Georgia United States 30501
    27 University of Chicago; Neurology Chicago Illinois United States 60637
    28 Southern Illinois University, School of Medicine Springfield Illinois United States 62702
    29 Neuropsychiatric Research Winfield Illinois United States 60190
    30 Fort Wayne Neurological Center Fort Wayne Indiana United States 46805
    31 Josephson Wallack Munshower Neurology PC Indianapolis Indiana United States 46256
    32 Via Christi Research Wichita Kansas United States 67214
    33 Precise Research Centers Flowood Mississippi United States 39232
    34 University of Mississippi Medical Center Jackson Mississippi United States 39216
    35 Galen Clinical Research Chesterfield Missouri United States 63005
    36 NeuroCognitive Institute Mount Arlington New Jersey United States 07856
    37 Advanced Memory Research Institute of NJ Toms River New Jersey United States 08755
    38 Neurology Specialists of Monmouth County, PA West Long Branch New Jersey United States 07764
    39 Neurological Associates of Long Island, PC Lake Success New York United States 11042
    40 Weill Cornell Memory Disorders New York New York United States 10021
    41 Columbia University Medical Center New York New York United States 10032
    42 Richard H Weisler, MD Raleigh North Carolina United States 27609
    43 Ohio State University; College of Medicine Columbus Ohio United States 43210
    44 UC Health Neurology Dayton Ohio United States 45417
    45 Oregon Center for Clinical Investigations, Inc Portland Oregon United States 97210
    46 Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center Portland Oregon United States 97239
    47 Abington Neurological Associates Abington Pennsylvania United States 19001
    48 The Clinical Trial Center, LLC Jenkintown Pennsylvania United States 19046
    49 Drexel University; College of Medicine Philadelphia Pennsylvania United States 19102
    50 Medical University of South Carolina Charleston South Carolina United States 29425
    51 Coastal Neurology Port Royal South Carolina United States 29935
    52 University of Tennessee Medical Center Knoxville Tennessee United States 37920
    53 Clinical Research Associates Nashville Tennessee United States 37203
    54 FutureSearch Trials, LP Austin Texas United States 78731
    55 Senior Adults Specialty Research Austin Texas United States 78757
    56 Neurology Consultants of Dallas; Research Department Dallas Texas United States 75243
    57 University Hills Clinical Research Irving Texas United States 75062
    58 Wasatch Clinical Research, LLC Salt Lake City Utah United States 84107
    59 University of Virginia Charlottesville Virginia United States 22906
    60 Sentara Neurology Specialists Norfolk Virginia United States 23507
    61 Neurological Associates, Inc. Richmond Virginia United States 23229
    62 National Clinical Research Inc.-Richmond Richmond Virginia United States 23294
    63 Northwest Clinical Research Center Bellevue Washington United States 98007
    64 UW Wisconsin-Madison Madison Wisconsin United States 53705
    65 St Vincent's Hospital Sydney; Neurology Darlinghurst New South Wales Australia 2010
    66 Central Coast Neurosciences Research Erina New South Wales Australia 2250
    67 Southern Neurology Kogarah New South Wales Australia 2217
    68 Calvary Mater Newcastle Waratah New South Wales Australia 2298
    69 Queensland University of Technology Mermaid Waters Queensland Australia 4218
    70 The Queen Elizabeth Hospital; Neurology Woodville South Australia Australia 5011
    71 Peninsula Therapeutic & Research Group Frankston Victoria Australia 3199
    72 Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre Heidelberg West Victoria Australia 3081
    73 HammondCare Aged Psychiatry Clinical Trials Malvern Victoria Australia 3144
    74 Neuro Trials Victoria Noble Park Victoria Australia 3174
    75 Australian Alzheimer's Research Foundation Nedlands Western Australia Australia 6009
    76 CCBR - Brasilia Brasilia DF Brazil 70200-730
    77 Flumignano Instituto de Medicina Curitiba PR Brazil 80045-120
    78 Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia Curitiba PR Brazil 80810-040
    79 Instituto de Neurologia de Curitiba Curitiba PR Brazil 81210-310
    80 Clinica Clinilive ltda Maringa PR Brazil 87013-250
    81 Instituto de Psiquiatria - UFRJ Rio de Janeiro RJ Brazil 22290-140
    82 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
    83 Universidade Federal de São Carlos Sao Carlos SP Brazil 13565-905
    84 Universidade Federal de Sao Paulo - UNIFES Sao Paulo SP Brazil 04026-000
    85 Clínica Dr. Norton Sayeg LTDA - EPP Sao Paulo SP Brazil 04534-011
    86 Hospital das Clinicas - FMUSP_X; Neurologia Sao Paulo SP Brazil 05403-000
    87 The Med Arts Health Rsrch Grp Kelowna British Columbia Canada V1Y 3G8
    88 Medical Arts Health Research Group Penticton British Columbia Canada V1Y 1Z9
    89 The Medical Clinic Associates Powell River British Columbia Canada V8A 3B6
    90 Vancouver Hospital - UBC Hospital Site Vancouver British Columbia Canada V6Z 1Y6
    91 The Medical Arts Health Research Group - West Vancouver Vancouver British Columbia Canada V7T 2Z3
    92 Vancouver Island Health Authority Victoria British Columbia Canada V8R 1J8
    93 True North Clinical Research-Halifax Halifax Nova Scotia Canada B3S 1N2
    94 Parkwood Hospital; Geriatric Medicine London Ontario Canada N6C 5J1
    95 Centre for Memory and Aging Toronto Ontario Canada M4G 3E8
    96 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    97 St. Michael'S Hospital Toronto Ontario Canada M5B 1W8
    98 Toronto Western Hospital Toronto Ontario Canada M5T 2S8
    99 Baycrest Health Sciences Toronto Ontario Canada M6A 2E1
    100 Devonshire Clinical Research Woodstock Ontario Canada N4S 5P5
    101 Center for Diagnosis and Research on Alzheimer's disease Greenfield Park Quebec Canada J4V 2J2
    102 Institute Universitaire de Geriatrie de Montreal Montréal Quebec Canada H3W 1W5
    103 CHA Hopital de I enfant-Jesus Quebec City Quebec Canada G1J 1Z4
    104 Q & T Research Sherbrooke Sherbrooke Quebec Canada J1J 2G2
    105 Royal University Hospital Saskatoon Saskatchewan Canada S7N 0W8
    106 Alpha Recherche Clinique Quebec Canada G3K 2P8
    107 China-Japan Friendship Hospital Beijing City China 100029
    108 Beijing Anding Hospital, Capital Medical University Beijing City China 100032
    109 Peking Union Medical College Hospital Beijing City China 100032
    110 Beijing Tian Tan Hospital,Capital Medical University Beijing China
    111 West China Hospital, Sichuan University Chengdu China 610041
    112 The First Affiliated Hospital, Chongqing Medical University Chongqing China 400016
    113 Fujian Medical University Union Hospital Fuzhou City China 350001
    114 Guangdong Provincial People's Hospital; Breast Guangzhou City China 510180
    115 Sun Yat-sen Memorial Hospital; Neurology Guangzhou China 510000
    116 Guangzhou First Municipal People's Hospital Guangzhou China 510180
    117 The Second Affiliated Hospital, Zhejiang University Hangzhou China 310009
    118 Sir Run Run Shaw Hospital Hangzhou China 310016
    119 Anhui Provincial Hospital Hefei China 230001
    120 The First Affiliated Hospital of Anhui Medical University Hefei China 230022
    121 The Second Affiliated Hospital to Nanchang University Nanchang China 330006
    122 Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing City China 210008
    123 Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) Nanjing City China 210029
    124 Zhongda Hospital Affiliated to Southeast University Nanjing China 210009
    125 Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai City China 200025
    126 Huashan Hospital Affiliated to Fudan University Shanghai City China 200040
    127 Shanghai Tenth People's Hospital Shanghai China 200072
    128 Shanghai First People's Hospital Shanghai China 200080
    129 Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China 200092
    130 Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China 200233
    131 The University of Hong Kong-Shenzhen Hospital Shenzhen City China 518053
    132 Tianjin Medical University General Hospital Tianjin China 300052
    133 The First Affiliated Hospital of Wenzhou Medical College Wenzhou China 325000
    134 Tangdu Hospital, The Fourth Military Medical University; Neurology Department Xi'an City China 710038
    135 Northern Jangsu People's Hospital Yangzhou City China 225001
    136 Henan Provincial People's Hospital Zhengzhou China 450003
    137 Centro de Investigaciones y Proyectos en Neurociencias CIPNA Barranquilla Colombia 080020
    138 Hospital Universitario San Ignacio Bogota Colombia 000472
    139 CHU Amiens Hopital Sud; Neurologie Amiens Cedex1 France 80054
    140 CHU Angers Angers France 49933
    141 Hôpital Avicenne; Centre de Recherche Clinique Bobigny Cedex France 93009
    142 Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie Bordeaux France 33076
    143 Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502) Bron cedex France 69677
    144 CHU de la Timone - Hopital d Adultes; Service de Neurologie Marseille France 13005
    145 Hôpital Lariboisière Paris France 75010
    146 CH Pitie Salpetriere; IM2A Paris France 75651
    147 CHU Poitiers - Hopital La Miletrie Poitiers France 86000
    148 CHU Strasbourg - Hôpital Hautepierre Strasbourg France 67098
    149 Gerontopole; Centre de Recherche clinique Toulouse France 31059
    150 Hopital des Charpennes Villeurbanne France 69100
    151 Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin Berlin Germany 12200
    152 ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic Berlin Germany 13125
    153 St. Josef-Hospital, Klinik für Neurologie Bochum Germany 44791
    154 Universitätsklinikum Düsseldorf; Klinik für Neurologie Düsseldorf Germany 40225
    155 NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich Erbach/Odenwald Germany 64711
    156 Universitätsklinikum Essen, Elisabeth-Krankenhaus, Klinik für Geriatrie, Haus Berge, Contilia GmbH Essen Germany 45356
    157 Universitätsklinikum Hamburg-Eppendorf Zentrum f.Psychosoz.Medizin Klinik f.Psychiatrie Hamburg Germany 20246
    158 Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie Homburg/Saar Germany 66421
    159 Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie Köln Germany 50937
    160 PANAKEIA - Arzneimittelforschung Leipzig GmbH Leipzig Germany 04275
    161 Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi Mainz Germany 55131
    162 Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie München Germany 81675
    163 Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie Münster Germany 48149
    164 Universitätsklinikum Rostock Zentrum für Nervenheilkunde Rostock Germany 18147
    165 ZNS Siegen im MVZ Weidenau Siegen Germany 57076
    166 Universitätsklinikum Ulm; Klinik für Neurologie Ulm Germany 89081
    167 Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz Westerstede Germany 26655
    168 Forschungszentrum Ruhr Witten Germany 58455
    169 Semmelweis University; Department of Neurology Budapest Hungary 1083
    170 Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze Modena Emilia-Romagna Italy 41126
    171 Policlinico Universitario Agostino Gemelli; UOC Neurologia Roma Lazio Italy 00168
    172 Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica Roma Lazio Italy 00179
    173 Umberto I Policlinico di Roma-Università di Roma La Sapienza Roma Lazio Italy 00185
    174 Ospedale San Giovanni Calibita Fatebenefratell;Neurologia Roma Lazio Italy 00186
    175 Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia Genova Liguria Italy 16128
    176 IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer Brescia Lombardia Italy 25125
    177 IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria Milano Lombardia Italy 20132
    178 Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative Milano Lombardia Italy 20144
    179 ASST DI MONZA; Neurologia Monza Lombardia Italy 20900
    180 IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA Pozzilli Molise Italy 86077
    181 AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria Torino Piemonte Italy 10126
    182 Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Sicilia Italy 90127
    183 Medical Corporation Hakuyokai Kashiwado Hospital Chiba Japan 260-8656
    184 National Hospital Organization Chiba-East Hospital Chiba Japan 260-8712
    185 Tokyo Bay Advanced Medical and Makuhari Clinic Chiba Japan 261-0024
    186 Inage Neurology and Memory Clinic Chiba Japan 263-0043
    187 Juntendo University Urayasu Hospital Chiba Japan 279-0021
    188 Southern Tohoku Medical Clinic Fukushima Japan 963-8052
    189 Yuai Clinic Kanagawa Japan 223-0059
    190 Shonan Kamakura General Hospital Kanagawa Japan 247-8533
    191 Mishima Hospital Niigata Japan 940-2302
    192 NHO Shizuoka Institute of Epilepsy and Neurological Disorders Shizuoka Japan 420-8688
    193 Shizuoka City Shimizu Hospital Shizuoka Japan 424-0911
    194 Jichiidai Station Brain Clinic Tochigi Japan 329-0403
    195 Yotsuya Medical Cube Tokyo Japan 102-0084
    196 Tokyo Medical and Dental University Hospital Tokyo Japan 113-8519
    197 Tokyo Medical University Hospital Tokyo Japan 160-0023
    198 Shinjuku Research Park Clinic Tokyo Japan 169-0073
    199 Tokyo Metropolitan Geriatric Hospital Tokyo Japan 173-0015
    200 Nozomi Memory Clinic Tokyo Japan 181-0013
    201 National Center of Neurology and Psychiatry Tokyo Japan 187-8551
    202 P-One Clinic Tokyo Japan 192-0071
    203 Yamagata Tokusyukai Hospital Yamagata Japan 990-0834
    204 Vilnius University Hospital Santariskiu Clinics; Neurology Vilnius Lithuania 08661
    205 Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion Bellavista Peru Callao 2
    206 Clinica Internacional; Unidad De Investigacion Lima Peru 15001
    207 Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia Lima Peru 15003
    208 Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional Lima Peru Lima 41
    209 Hospital Nacional Cayetano Heredia; Servicio de Neurologia San Martin de Porres Peru 15102
    210 FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency Krasnoyarsk Krasnojarsk Russian Federation 660037
    211 University сlinic of headaches Moscow Moskovskaja Oblast Russian Federation 121467
    212 State Autonomous Healthcare Institution "Republican Clinical Neurological Center Kazan Russian Federation 420021
    213 State autonomous institution of healthcare Inter-regional clinical and diagnostic center Kazan Russian Federation 420101
    214 Central Clinical Hospital #2 N.A. Semashko OAO RJHD Moscow Russian Federation 107150
    215 City Clin Hosp n.a. S.P.Botkin Moscow Russian Federation 125101
    216 Samara Psychiatric Hospital Samara Russian Federation 443016
    217 City Clinical Hospital # 2 n.a. V.I. Razumovsky Saratov Russian Federation 410028
    218 City Psychiatric Hospital #3 of Skvortsov-Stepanov St Petersburg Russian Federation 197341
    219 Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department St. Petersburg Russian Federation 194044
    220 SBHI SR Region Specialized Psychiatric Hospital #2 Stavropol Russian Federation 357034
    221 Nebbiolo Center for Clinical Trials Tomsk Russian Federation 634009
    222 Llc Lion-Med Voronezh Russian Federation 394052
    223 Hospital Universitari de Bellvitge; Servicio de Neurologia L'Hospitalet de Llobregat Barcelona Spain 08907
    224 Hospital General De Catalunya; Servicio de Neurologia Sant Cugat del Valles Barcelona Spain 8195
    225 Hospital Universitario Marques de Valdecilla; Servicio de Neurología SANtander Cantabria Spain 39011
    226 UVaMID Hospital Santa Caterina;; Servicio de Neurología Salt Girona Spain 17090
    227 Hospital San Pedro; Servicio de Neurología Logroño LA Rioja Spain 26006
    228 HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría Móstoles Madrid Spain 28938
    229 Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría Salamaca Salamanca Spain 37007
    230 Hospital General Universitario de Albacete; Servicio de Neurología Albacete Spain
    231 Hospital Universitari Quiron Dexeus;; Servicio Neurología Barcelona Spain 08028
    232 Hospital Vall d'Hebron; Servicio de Neurología Barcelona Spain 08035
    233 Hospital Clinic i Provincial; Servicio de Neurologia Barcelona Spain 08036
    234 Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia Barcelona Spain 08041
    235 Hospital Universitario Reina Sofia; Servicio de Neurologia Cordoba Spain 14011
    236 Hospital Ramon y Cajal; Servicio de Neurologia Madrid Spain 28034
    237 Hospital Ruber Internacional; Servicio de Neurología Madrid Spain 28034
    238 Hospital Universitario 12 de Octubre; Servicio de Neurologia Madrid Spain 28041
    239 Hospital Virgen del Rocío; Servicio de Neurología Sevilla Spain 41013
    240 Hospital Universitario Dr. Peset; Servicio de Neurologia Valencia Spain 46017
    241 Servicio de Neurología Hospital Viamed Montecanal. Zaragoza Spain 50012
    242 Changhua Christian Hospital; Neurology Changhua County Taiwan 500
    243 Kaohsiung Medical University Hospital; Neurology Kaohsiung Taiwan 807
    244 Chang Gung Memorial Foundation - Kaohsiung - Neurology Niaosong Dist. Taiwan 83301
    245 China Medical University Hospital; Neurology North Dist. Taiwan 40447
    246 National Taiwan University Hospital; Neurology Taipei Taiwan 100
    247 Taipei Veterans General Hospital-Neurology Taipei Taiwan 11217
    248 Chang Gung Memorial Foundation - Linkou - Neurology Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03444870
    Other Study ID Numbers:
    • WN29922
    • 2017-001364-38
    First Posted:
    Feb 23, 2018
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Aug 1, 2022