A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04374253
Collaborator
(none)
2,032
277
2
70.7
7.3
0.1
Study Details
Study Description
Brief Summary
This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Participants who were in the active arm in the double blind part and those who have completed OLE part in the parent study, will continue receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W). Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme as in the parent study before receiving target dose of open label gantenerumab.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
2032 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease
Actual Study Start Date
:
Feb 1, 2021
Anticipated Primary Completion Date
:
Dec 25, 2026
Anticipated Study Completion Date
:
Dec 25, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Participants, who completed the double-blind part and did not enter the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the Week 116 visit of Study WN29922 or WN39658. This will be considered the OLE baseline visit (OLE Day 1). |
Drug: Gantenerumab
Group 1 participants who were in the active arm in the double blind part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W. Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme before receiving target dose of open label gantenerumab, 510 mg SC, Q2W.
|
| Experimental: Group 2 Participants, who completed the double-blind part and the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the OLE Week 34 visit or the final dose visit in the Study WN29922 or WN39658 OLE. |
Drug: Gantenerumab
Group 2 participants who have completed OLE part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [From Baseline (OLE Day 1) to Week 208]
- Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [From Baseline (OLE Day 1) to Week 208]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [From Baseline (OLE Day 1) to Week 208]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI [From Baseline (OLE Day 1) to Week 208]
- Percentage of Participants with Injection-Site Reactions (ISRs) [From Baseline (OLE Day 1) to Week 208]
Secondary Outcome Measures
- Change in Clinical Dementia Rating (CDR) Score [From Baseline (OLE Day 1) to Week 208]
- Change in Mini-Mental State Examination (MMSE) Score [From Baseline (OLE Day 1) to Week 208]
- Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score [From Baseline (OLE Day 1) to Week 208]
- Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score [From Baseline (OLE Day 1) to Week 208]
- Change in Verbal Fluency Task Score [From Baseline (OLE Day 1) to Week 208]
- Change in Coding [From Baseline (OLE Day 1) to Week 208]
- Change in Functional Activities Questionnaire (FAQ) Score [From Baseline (OLE Day 1) to Week 208]
- Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score [From Baseline (OLE Day 1) to Week 208]
- Percentage of Participants with Anti-drug Antibody (ADA) to Gantenerumab [From Baseline (OLE Day 1) to Week 208]
Other Outcome Measures
- Plasma Concentration of Gantenerumab Administered SC [From Baseline (OLE Day 1) to Week 208]
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:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
-
The participant should be capable of completing assessments either alone or with the help of the caregiver
-
Availability of a person (referred to as the "caregiver")
-
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of <1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
-
Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
Exclusion Criteria:
-
Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
-
Prematurely discontinued from Study WN29922 or WN39658
-
Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
-
Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
-
Evidence of disseminated leptomeningeal hemosiderosis
-
Evidence of intracerebral macrohemorrhage
-
Use of prohibited medication
-
Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
| 2 | Barrow Neurological Institute | Phoenix | Arizona | United States | 85013 |
| 3 | Banner Sun Health Research Insitute | Sun City | Arizona | United States | 85351 |
| 4 | Health Initiatives Research, PLLC | Fayetteville | Arkansas | United States | 72703 |
| 5 | Fullerton Neurology and Headache Center | Fullerton | California | United States | 92835 |
| 6 | Neurology Center of North Orange County | Fullerton | California | United States | 92835 |
| 7 | Irvine Center for Clinical Research | Irvine | California | United States | 92614 |
| 8 | Desert Valley Research | Redlands | California | United States | 92374 |
| 9 | Sutter Medical Group, Neurology | Sacramento | California | United States | 95816 |
| 10 | Syrentis Clinical Research | Santa Ana | California | United States | 92705 |
| 11 | California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | United States | 91403 |
| 12 | Southern California Research LLC | Simi Valley | California | United States | 93065 |
| 13 | Yale University School Of Medicine | New Haven | Connecticut | United States | 06519 |
| 14 | Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | United States | 06851 |
| 15 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 16 | JEM Research LLC | Atlantis | Florida | United States | 33462 |
| 17 | Accel Research Sites - CRU Tampa | Bradenton | Florida | United States | 34201 |
| 18 | Bradenton Research Center | Bradenton | Florida | United States | 34205 |
| 19 | Brain Matters Research, Inc. | Delray Beach | Florida | United States | 33445 |
| 20 | ClinCloud, LLC | Maitland | Florida | United States | 32751 |
| 21 | Optimus U Corp | Miami | Florida | United States | 33125 |
| 22 | Allied Biomedical Research Institute, Inc | Miami | Florida | United States | 33155 |
| 23 | Renstar Medical Research | Ocala | Florida | United States | 34470 |
| 24 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 25 | Intercoastal Medical Group | Sarasota | Florida | United States | 34239 |
| 26 | Infinity Clinical Research, LLC | Sunrise | Florida | United States | 33351 |
| 27 | Axiom Clinical Research of Florida | Tampa | Florida | United States | 33609 |
| 28 | Alzheimer's Research and Treatment Center | Wellington | Florida | United States | 33414 |
| 29 | Emory University | Atlanta | Georgia | United States | 30329 |
| 30 | Center for Advanced Research & Education | Gainesville | Georgia | United States | 30501 |
| 31 | Southern Illinois University, School of Medicine | Springfield | Illinois | United States | 62702 |
| 32 | American Health Network Institute, LLC | Avon | Indiana | United States | 46123 |
| 33 | Fort Wayne Neurological Center | Fort Wayne | Indiana | United States | 46805 |
| 34 | Via Christi Research | Wichita | Kansas | United States | 67214 |
| 35 | Brigham and Womens Hospital; Center for Alzheimer Research & Treatment | Boston | Massachusetts | United States | 02115 |
| 36 | Boston Center for Memory | Newton | Massachusetts | United States | 02459 |
| 37 | Precise Research Centers | Flowood | Mississippi | United States | 39232 |
| 38 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 39 | Missouri Memory Center | Bolivar | Missouri | United States | 65613 |
| 40 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 41 | University of Nebraska Medical Center; Dept of Neurological Sciences | Omaha | Nebraska | United States | 68198-8440 |
| 42 | Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | United States | 89106 |
| 43 | The Cognitive and Research Center of New Jersey | Springfield | New Jersey | United States | 07081 |
| 44 | Advanced Memory Research Institute of NJ | Toms River | New Jersey | United States | 08755 |
| 45 | Neurological Associates of Long Island, PC | Lake Success | New York | United States | 11042 |
| 46 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 47 | AD-CARE, University of Rochester Medical Center | Rochester | New York | United States | 14620 |
| 48 | Richmond Behavioral Associates | Staten Island | New York | United States | 10314 |
| 49 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 50 | Behavioral Health Research | Charlotte | North Carolina | United States | 28211 |
| 51 | Alzheimer's Memory Center | Matthews | North Carolina | United States | 28105 |
| 52 | Raleigh Neurology Associates | Raleigh | North Carolina | United States | 27607-6520 |
| 53 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
| 54 | Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health - Neurological Institute | Cleveland | Ohio | United States | 44195 |
| 55 | Ohio State University; College of Medicine | Columbus | Ohio | United States | 43210 |
| 56 | Summit Research Network Inc. | Portland | Oregon | United States | 97210 |
| 57 | Abington Neurological Associates | Abington | Pennsylvania | United States | 19001 |
| 58 | The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | United States | 19046 |
| 59 | Senior Adults Specialty Research | Austin | Texas | United States | 78757 |
| 60 | Kerwin Medical Center | Dallas | Texas | United States | 75231 |
| 61 | Neurology Consultants of Dallas; Research Department | Dallas | Texas | United States | 75243 |
| 62 | Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 63 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77054 |
| 64 | Wasatch Clinical Research, LLC | Salt Lake City | Utah | United States | 84107 |
| 65 | University of Virginia | Charlottesville | Virginia | United States | 22906 |
| 66 | Sentara Neurology Specialists | Norfolk | Virginia | United States | 23507 |
| 67 | National Clinical Research Inc.-Richmond | Richmond | Virginia | United States | 23294 |
| 68 | UW Wisconsin-Madison | Madison | Wisconsin | United States | 53705 |
| 69 | Hospital Italiano | Caba | Argentina | C1199ABB | |
| 70 | Universidad Maimonides | Caba | Argentina | C1405BCK | |
| 71 | Instituto Geriatrico Nuestra Señora de las Nieves | Capital Federal | Argentina | C1427CCP | |
| 72 | CEN Centro Especializado en Neurociencias | Cordoba | Argentina | X5004FJF | |
| 73 | Instituto Kremer | Córdoba | Argentina | X5004AOA | |
| 74 | Instituto de Neurociencias San Agustín S.A. | La Plata | Argentina | B1902AVF | |
| 75 | Fundación Scherbovsky; General Department | Mendoza | Argentina | M5500AYB | |
| 76 | St Vincent's Hospital Sydney; Neurology | Darlinghurst | New South Wales | Australia | 2010 |
| 77 | Central Coast Neurosciences Research | Erina | New South Wales | Australia | 2250 |
| 78 | Southern Neurology | Kogarah | New South Wales | Australia | 2217 |
| 79 | The Queen Elizabeth Hospital; Neurology | Woodville | South Australia | Australia | 5011 |
| 80 | Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre | Heidelberg West | Victoria | Australia | 3081 |
| 81 | Australian Alzheimer's Research Foundation | Nedlands | Western Australia | Australia | 6009 |
| 82 | AZ Sint Blasius (Dendermonde) | Dendermonde | Belgium | 9200 | |
| 83 | UZ Gent | Gent | Belgium | 9000 | |
| 84 | Jessa Zkh (Campus Virga Jesse) | Hasselt | Belgium | 3500 | |
| 85 | Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia | Curitiba | PR | Brazil | 80810-040 |
| 86 | Instituto de Neurologia de Curitiba | Curitiba | PR | Brazil | 81210-310 |
| 87 | Clinica Clinilive ltda | Maringa | PR | Brazil | 87013-250 |
| 88 | Hospital das Clinicas - UFRGS | Porto Alegre | RS | Brazil | 90035-903 |
| 89 | Hospital das Clinicas - FMUSP_X; Neurologia | Sao Paulo | SP | Brazil | 05403-000 |
| 90 | The Medical Arts Health Research Group - West Vancouver | Vancouver | British Columbia | Canada | V7T 2Z3 |
| 91 | Parkwood Hospital; Geriatric Medicine | London | Ontario | Canada | N6C 5J1 |
| 92 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 93 | Baycrest Health Sciences | Toronto | Ontario | Canada | M6A 2E1 |
| 94 | Devonshire Clinical Research | Woodstock | Ontario | Canada | N4S 5P5 |
| 95 | Center for Diagnosis and Research on Alzheimer's disease | Greenfield Park | Quebec | Canada | J4V 2J2 |
| 96 | Alpha Recherche Clinique | Quebec | Canada | G3K 2P8 | |
| 97 | Psicomed Estudios Médicos | Antofagasta | Chile | 1270244 | |
| 98 | Biomedica Research Group | Santiago | Chile | 7500710 | |
| 99 | Especialidades Medicas LYS | Santiago | Chile | 7560356 | |
| 100 | Beijing Tian Tan Hospital,Capital Medical University | Beijing | China | ||
| 101 | Clinical Hospital Centre Zagreb;Clinic for Neurology | Zagreb | Croatia | 10000 | |
| 102 | Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken | Aarhus N | Denmark | 8200 | |
| 103 | Rigshospitalet, Hukommelsesklinikken | Koebenhavn Oe | Denmark | 2100 | |
| 104 | Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn | Svendborg | Denmark | 5700 | |
| 105 | Terveystalo Ruoholahti | Helsinki | Finland | 00180 | |
| 106 | Itä-Suomen yliopisto, Kuopion kampus | Kuopio | Finland | 70210 | |
| 107 | CHU Amiens Hopital Sud; Neurologie | Amiens Cedex1 | France | 80054 | |
| 108 | Hôpital Avicenne; Centre de Recherche Clinique | Bobigny Cedex | France | 93009 | |
| 109 | Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502) | Bron cedex | France | 69677 | |
| 110 | CHU de la Timone - Hopital d Adultes; Service de Neurologie | Marseille | France | 13005 | |
| 111 | Hôpital Lariboisière | Paris | France | 75010 | |
| 112 | CHU Poitiers - Hopital La Miletrie | Poitiers | France | 86000 | |
| 113 | CHU Strasbourg - Hôpital Hautepierre | Strasbourg | France | 67098 | |
| 114 | Gerontopole; Centre de Recherche clinique | Toulouse | France | 31059 | |
| 115 | Hopital des Charpennes | Villeurbanne | France | 69100 | |
| 116 | Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin | Berlin | Germany | 12200 | |
| 117 | ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic | Berlin | Germany | 13125 | |
| 118 | Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie | Köln | Germany | 50937 | |
| 119 | PANAKEIA - Arzneimittelforschung Leipzig GmbH | Leipzig | Germany | 04275 | |
| 120 | Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi | Mainz | Germany | 55131 | |
| 121 | Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie | München | Germany | 81675 | |
| 122 | Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie | Münster | Germany | 48149 | |
| 123 | Universitätsklinikum Rostock Zentrum für Nervenheilkunde | Rostock | Germany | 18147 | |
| 124 | Universitätsklinikum Ulm; Klinik für Neurologie | Ulm | Germany | 89081 | |
| 125 | Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz | Westerstede | Germany | 26655 | |
| 126 | Forschungszentrum Ruhr | Witten | Germany | 58455 | |
| 127 | Semmelweis University; Department of Neurology | Budapest | Hungary | 1083 | |
| 128 | Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze | Modena | Emilia-Romagna | Italy | 41126 |
| 129 | Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica | Roma | Lazio | Italy | 00179 |
| 130 | Umberto I Policlinico di Roma-Università di Roma La Sapienza | Roma | Lazio | Italy | 00185 |
| 131 | Ospedale San Giovanni Calibita Fatebenefratell;Neurologia | Roma | Lazio | Italy | 00186 |
| 132 | IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer | Brescia | Lombardia | Italy | 25125 |
| 133 | IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria | Milano | Lombardia | Italy | 20132 |
| 134 | ASST DI MONZA; Neurologia | Monza | Lombardia | Italy | 20900 |
| 135 | IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA | Pozzilli | Molise | Italy | 86077 |
| 136 | AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria | Torino | Piemonte | Italy | 10126 |
| 137 | Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Sicilia | Italy | 90127 |
| 138 | Yachiyo Hospital | Aichi | Japan | 446-8510 | |
| 139 | Nagoya Ekisaikai Hospital | Aichi | Japan | 454-8502 | |
| 140 | National Center for Geriatrics and Gerontology | Aichi | Japan | 474-8511 | |
| 141 | Medical Corporation Hakuyokai Kashiwado Hospital | Chiba | Japan | 260-8656 | |
| 142 | Tokyo Bay Advanced Medical and Makuhari Clinic | Chiba | Japan | 261-0024 | |
| 143 | Inage Neurology and Memory Clinic | Chiba | Japan | 263-0043 | |
| 144 | Juntendo University Urayasu Hospital | Chiba | Japan | 279-0021 | |
| 145 | Fukuoka University Hospital | Fukuoka | Japan | 814-0180 | |
| 146 | Southern Tohoku Medical Clinic | Fukushima | Japan | 963-8052 | |
| 147 | National Hospital Organization Hiroshima-Nishi Medical Center | Hiroshima | Japan | 739-0696 | |
| 148 | Kobe University Hospital | Hyogo | Japan | 650-0017 | |
| 149 | Hyogo Prefectural HarimaHimeji General Medical Center | Hyogo | Japan | 670-8560 | |
| 150 | Tsukazaki Hospital | Hyogo | Japan | 671-1227 | |
| 151 | Matsui Dietary and Dementia Clinic | Hyogo | Japan | 673-0891 | |
| 152 | Kagawa Prefectural Central Hospital | Kagawa | Japan | 760-8557 | |
| 153 | Yuai Clinic | Kanagawa | Japan | 223-0059 | |
| 154 | Shonan Kamakura General Hospital | Kanagawa | Japan | 247-8533 | |
| 155 | Rakuwakai Otowa Hospital | Kyoto | Japan | 607-8062 | |
| 156 | Uji Takeda Hospital | Kyoto | Japan | 611-0021 | |
| 157 | Mishima Hospital | Niigata | Japan | 940-2302 | |
| 158 | Okayama Kyokuto Hospital | Okayama | Japan | 703-8265 | |
| 159 | Rijikai Medical Corporation Katayama Medical Clinic | Okayama | Japan | 710-0813 | |
| 160 | MI Clinic | Osaka | Japan | 560-0004 | |
| 161 | Kishiwada Tokushukai Hospital | Osaka | Japan | 596-0042 | |
| 162 | National Hospital Organization Hizen Psychiatric Medical Center | Saga | Japan | 842-0192 | |
| 163 | NHO Shizuoka Institute of Epilepsy and Neurological Disorders | Shizuoka | Japan | 420-8688 | |
| 164 | Shizuoka City Shimizu Hospital | Shizuoka | Japan | 424-0911 | |
| 165 | Jichiidai Station Brain Clinic | Tochigi | Japan | 329-0403 | |
| 166 | Medical corporation Ichiekai Itsuki Hospital | Tokushima | Japan | 770-0852 | |
| 167 | Tokushima Hospital | Tokushima | Japan | 776-8585 | |
| 168 | Yotsuya Medical Cube | Tokyo | Japan | 102-0084 | |
| 169 | Tokyo Medical and Dental University Hospital | Tokyo | Japan | 113-8519 | |
| 170 | Tokyo Medical University Hospital | Tokyo | Japan | 160-0023 | |
| 171 | Nozomi Memory Clinic | Tokyo | Japan | 181-0013 | |
| 172 | National Center of Neurology and Psychiatry | Tokyo | Japan | 187-8551 | |
| 173 | P-One Clinic | Tokyo | Japan | 192-0071 | |
| 174 | Yamagata Tokusyukai Hospital | Yamagata | Japan | 990-0834 | |
| 175 | Dong-A University Hospital | Busan | Korea, Republic of | 49201 | |
| 176 | Myongji Hospital | Gyeonggi-do | Korea, Republic of | 10475 | |
| 177 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | 21565 | |
| 178 | Inha University Hospital | Incheon | Korea, Republic of | 22332 | |
| 179 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13605 | |
| 180 | Hanyang University Seoul Hospital | Seoul | Korea, Republic of | 04763 | |
| 181 | Konkuk University Medical Center | Seoul | Korea, Republic of | 05030 | |
| 182 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 183 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 184 | Seoul St Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 185 | Ewha Womans University Hospital (Seoul) | Seoul | Korea, Republic of | 07804 | |
| 186 | Vilnius University Hospital Santariskiu Clinics; Neurology | Vilnius | Lithuania | 08661 | |
| 187 | Mexico Centre for Clinical Research | Ciudad de México | Mexico CITY (federal District) | Mexico | 03100 |
| 188 | Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC | Culiacan | Mexico | 80020 | |
| 189 | Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta | Monterrey | Mexico | 64460 | |
| 190 | AVIX Investigación Clínica S.C | Monterrey | Mexico | 64710 | |
| 191 | Brain Research Center B.V | Amsterdam | Netherlands | 1081 GN | |
| 192 | Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion | Bellavista | Peru | Callao 2 | |
| 193 | Clinica Internacional; Unidad De Investigacion | Lima | Peru | 15001 | |
| 194 | Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia | Lima | Peru | 15003 | |
| 195 | Podlaskie Centrum Psychogeriatrii | Białystok | Poland | 15-756 | |
| 196 | NZOZ Vitamed | Bydgoszcz | Poland | 85-079 | |
| 197 | KO-MED Centra Kliniczne Lublin II | Lublin | Poland | 20-362 | |
| 198 | Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych | Plewiska | Poland | 62-064 | |
| 199 | NEURO-CARE Sp. z o.o. Sp. Komandytowa | Siemianowice Śląskie | Poland | 41-100 | |
| 200 | Senior Sp. Z O.O. Poradnia Psychogeriatryczna | Sopot | Poland | 81-855 | |
| 201 | mMED Maciej Czarnecki | Warszawa | Poland | 01-684 | |
| 202 | Pratia S.A. | Warszawa | Poland | 01-868 | |
| 203 | NZOZ WCA | Wrocław | Poland | 53-659 | |
| 204 | Ośrodek Badawczo-Naukowo-Dydaktyczny Chorób Otępiennych w Ścinawie | Ścinawa | Poland | 59-330 | |
| 205 | Hospital de Braga; Servico de Neurologia | Braga | Portugal | 4710-243 | |
| 206 | HUC; Servico de Neurologia | Coimbra | Portugal | 3000-075 | |
| 207 | Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia | Guimarães | Portugal | ||
| 208 | Hospital Geral de Santo Antonio; Servico de Neurologia | Porto | Portugal | 4099-001 | |
| 209 | Santa Cruz Behavioral PSC | Bayamon | Puerto Rico | 00961 | |
| 210 | University of Puerto Rico - Medical Science Campus; Internal Medicine | San Juan | Puerto Rico | 00936 | |
| 211 | FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency | Krasnoyarsk | Krasnojarsk | Russian Federation | 660037 |
| 212 | University сlinic of headaches | Moscow | Moskovskaja Oblast | Russian Federation | 121467 |
| 213 | City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow | Moskva | Moskovskaja Oblast | Russian Federation | 117556 |
| 214 | FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF | Sankt-peterburg | Sankt Petersburg | Russian Federation | 194044 |
| 215 | State Autonomous Healthcare Institution "Republican Clinical Neurological Center | Kazan | Russian Federation | 420021 | |
| 216 | State autonomous institution of healthcare Inter-regional clinical and diagnostic center | Kazan | Russian Federation | 420101 | |
| 217 | City Clin Hosp n.a. S.P.Botkin | Moscow | Russian Federation | 125101 | |
| 218 | MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric | Sartatov | Russian Federation | 410028 | |
| 219 | Nebbiolo Center for Clinical Trials | Tomsk | Russian Federation | 634009 | |
| 220 | National University Hospital (NUH); Neuroscience | Singapore | Singapore | 117549 | |
| 221 | National Neuroscience Institute; Neurology | Singapore | Singapore | 308433 | |
| 222 | Hospital General Universitario de Elche; Servicio de Neurología | Elche | Alicante | Spain | 03203 |
| 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 Mutua De Terrasa; Servicio de Neurologia | Terrassa | Barcelona | Spain | 08222 |
| 226 | Hospital Virgen del Puerto. Servicio de Neurología | Plasencia | Caceres | Spain | 10600 |
| 227 | Hospital Universitario Marques de Valdecilla; Servicio de Neurología | SANtander | Cantabria | Spain | 39011 |
| 228 | Policlínica Guipuzcoa; Servicio de Neurología | Donostia-san Sebastian | Guipuzcoa | Spain | 20014 |
| 229 | Hospital San Pedro; Servicio de Neurología | Logroño | LA Rioja | Spain | 26006 |
| 230 | Hospital Universitario de Santa Maria; Servicio de Neurología | Lleida | Lerida | Spain | 25198 |
| 231 | HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría | Móstoles | Madrid | Spain | 28938 |
| 232 | Hospital Quiron de Madrid; Servicio de Neurologia | Pozuelo de Alarcon | Madrid | Spain | 28223 |
| 233 | Clinica Universitaria de Navarra; Servicio de Neurología | Pamplona | Navarra | Spain | 31008 |
| 234 | Clinica Universitaria de Navarra | Pamplona | Navarra | Spain | 31008 |
| 235 | Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría | Salamaca | Salamanca | Spain | 37007 |
| 236 | CAE OROITU; Servicio de Neurología | Getxo | Vizcaya | Spain | 48993 |
| 237 | Hospital General Universitario de Albacete; Servicio de Neurología | Albacete | Spain | ||
| 238 | Hospital del Mar; Servicio de Neurologia | Barcelona | Spain | 08003 | |
| 239 | Fundación ACE; Servicio de Neurología | Barcelona | Spain | 08028 | |
| 240 | Hospital Vall d'Hebron; Servicio de Neurología | Barcelona | Spain | 08035 | |
| 241 | Hospital Clinic i Provincial; Servicio de Neurologia | Barcelona | Spain | 08036 | |
| 242 | Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia | Barcelona | Spain | 08041 | |
| 243 | Hospital Universitario Reina Sofia; Servicio de Neurologia | Cordoba | Spain | 14011 | |
| 244 | Universitario de La Princesa; Servicio de Neurología | Madrid | Spain | 28006 | |
| 245 | Hospital Ramon y Cajal; Servicio de Neurologia | Madrid | Spain | 28034 | |
| 246 | Hospital Ruber Internacional; Servicio de Neurología | Madrid | Spain | 28034 | |
| 247 | Hospital Universitario 12 de Octubre; Servicio de Neurologia | Madrid | Spain | 28041 | |
| 248 | Hospital Virgen del Rocío; Servicio de Neurología | Sevilla | Spain | 41013 | |
| 249 | Hospital Victoria Eugenia; Servico Neurología | Sevilla | Spain | ||
| 250 | Hospital Universitario Dr. Peset; Servicio de Neurologia | Valencia | Spain | 46017 | |
| 251 | Hospital Universitario la Fe; Servicio de Neurologia | Valencia | Spain | 46026 | |
| 252 | Complejo Asistencial de Zamora; Servicio Psiquiatria | Zamora | Spain | 49021 | |
| 253 | Servicio de Neurología Hospital Viamed Montecanal. | Zaragoza | Spain | 50012 | |
| 254 | Skånes Universitetssjukhus Malmö, Minneskliniken | Malmö | Sweden | 211 46 | |
| 255 | Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry | Mölndal | Sweden | 431 41 | |
| 256 | KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54 | Stockholm | Sweden | 141 86 | |
| 257 | Changhua Christian Hospital; Neurology | Changhua County | Taiwan | 500 | |
| 258 | Kaohsiung Medical University Hospital; Neurology | Kaohsiung | Taiwan | 807 | |
| 259 | Chang Gung Memorial Foundation - Kaohsiung - Neurology | Niaosong Dist. | Taiwan | 83301 | |
| 260 | China Medical University Hospital; Neurology | North Dist. | Taiwan | 40447 | |
| 261 | National Taiwan University Hospital; Neurology | Taipei | Taiwan | 100 | |
| 262 | Chang Gung Memorial Foundation - Linkou - Neurology | Taoyuan | Taiwan | 333 | |
| 263 | Istanbul University Istanbul School of Medicine; Neurology | Istanbul | Turkey | 34093 | |
| 264 | Ondokuz Mayis Univ. Med. Fac.; Neurology | Samsun | Turkey | 55139 | |
| 265 | The Rice Centre; Royal United Hospital | Bath | United Kingdom | BA1 3NG | |
| 266 | Re:Cognition Health Birmingham | Birmingham | United Kingdom | B16 8LT | |
| 267 | The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre | Cheltenham | United Kingdom | GL53 9DZ | |
| 268 | Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit | Chertsey | United Kingdom | KT16 9AU | |
| 269 | Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit | Crowborough | United Kingdom | TN6 1HB | |
| 270 | Ninewells Hospital | Dundee | United Kingdom | DD12 9SY | |
| 271 | Queen Elizabeth University Hospital - PPDS | Glasgow | United Kingdom | G51 4TF | |
| 272 | St George's Hospital | London | United Kingdom | SW17 ORE | |
| 273 | Re:Cognition Health London | London | United Kingdom | W1G 9RU | |
| 274 | Charing Cross Hospital | London | United Kingdom | W6 8RF | |
| 275 | Campus for Ageing and Vitality | Newcastle | United Kingdom | NE4 5PL | |
| 276 | Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | United Kingdom | S10 2JF | |
| 277 | University Southampton NHS Foundation Trust; Wessex Neurologica Centre | Southampton | United Kingdom | SO166YD |
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:
NCT04374253
Other Study ID Numbers:
- WN42171
- 2020-000766-42
First Posted:
May 5, 2020
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 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: