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A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gantenerumab
Gantenerumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Alzheimer?s Institute
  • Barrow Neurological Institute
  • Banner Sun Health Research Insitute
  • Health Initiatives Research, PLLC
  • Fullerton Neurology and Headache Center
  • Neurology Center of North Orange County
  • Irvine Center for Clinical Research
  • Desert Valley Research
  • Sutter Medical Group, Neurology
  • Syrentis Clinical Research
  • California Neuroscience Research Medical Group, Inc
  • Southern California Research LLC
  • Yale University School Of Medicine
  • Research Center for Clinical Studies, Inc.
  • Georgetown University Medical Center
  • JEM Research LLC
  • Accel Research Sites - CRU Tampa
  • Bradenton Research Center
  • Brain Matters Research, Inc.
  • ClinCloud, LLC
  • Optimus U Corp
  • Allied Biomedical Research Institute, Inc
  • Renstar Medical Research
  • Intercoastal Medical Group
  • Infinity Clinical Research, LLC
  • Axiom Clinical Research of Florida
  • Alzheimer?s Research and Treatment Center
  • Emory University
  • Center for Advanced Research & Education
  • Southern Illinois University, School of Medicine
  • American Health Network Institute, LLC
  • Fort Wayne Neurological Center
  • Via Christi Research
  • Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
  • Boston Center for Memory
  • Precise Research Centers
  • University of Mississippi Medical Center
  • Missouri Memory Center
  • Washington University School of Medicine
  • University of Nebraska Medical Center; Dept of Neurological Sciences
  • Cleveland Clinic Lou Ruvo; Center for Brain Research
  • The Cognitive and Research Center of New Jersey
  • Advanced Memory Research Institute of NJ
  • Neurological Associates of Long Island, PC
  • Columbia University Medical Center
  • AD-CARE, University of Rochester Medical Center
  • Richmond Behavioral Associates
  • SUNY Upstate Medical University
  • Behavioral Health Research
  • Alzheimer's Memory Center
  • Raleigh Neurology Associates
  • Wake Forest University
  • Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute
  • Ohio State University; College of Medicine
  • Summit Research Network Inc.
  • Abington Neurological Associates
  • The Clinical Trial Center, LLC
  • Senior Adults Specialty Research
  • Kerwin Medical Center
  • Neurology Consultants of Dallas; Research Department
  • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
  • The University of Texas Health Science Center at Houston
  • Wasatch Clinical Research, LLC
  • University of Virginia
  • Sentara Neurology Specialists
  • National Clinical Research Inc.-Richmond
  • UW Wisconsin-Madison
  • Hospital Italiano
  • Universidad Maimonides
  • Instituto Geriatrico Nuestra Señora de las Nieves
  • CEN Centro Especializado en Neurociencias
  • Instituto Kremer
  • Instituto de Neurociencias San Agustín S.A.
  • Fundación Scherbovsky; General Department
  • St Vincent's Hospital Sydney; Neurology
  • Central Coast Neurosciences Research
  • Southern Neurology
  • The Queen Elizabeth Hospital; Neurology
  • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
  • Australian Alzheimer's Research Foundation
  • AZ Sint Blasius (Dendermonde)
  • UZ Gent
  • Jessa Zkh (Campus Virga Jesse)
  • Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
  • Instituto de Neurologia de Curitiba
  • Clinica Clinilive ltda
  • Hospital das Clinicas - UFRGS
  • Hospital das Clinicas - FMUSP_X; Neurologia
  • The Medical Arts Health Research Group - West Vancouver
  • Parkwood Hospital; Geriatric Medicine
  • Sunnybrook Health Sciences Centre
  • Baycrest Health Sciences
  • Devonshire Clinical Research
  • Center for Diagnosis and Research on Alzheimer's disease
  • Alpha Recherche Clinique
  • Psicomed Estudios Médicos
  • Biomedica Research Group
  • Especialidades Medicas LYS
  • Beijing Tian Tan Hospital,Capital Medical University
  • Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken
  • Rigshospitalet, Hukommelsesklinikken
  • Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn
  • Terveystalo Ruoholahti
  • Itä-Suomen yliopisto, Kuopion kampus
  • CHU Amiens Hopital Sud; Neurologie
  • Hôpital Avicenne; Centre de Recherche Clinique
  • Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
  • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Hôpital Lariboisière
  • CHU Poitiers - Hopital La Miletrie
  • CHU Strasbourg Hôpital Hautepierre
  • Gerontopole; Centre de Recherche clinique
  • Hopital des Charpennes
  • Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin
  • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
  • Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
  • PANAKEIA - Arzneimittelforschung Leipzig GmbH
  • Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
  • Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
  • Universitätsklinikum Rostock Zentrum für Nervenheilkunde
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
  • Forschungszentrum Ruhr
  • Semmelweis University; Department of Neurology
  • Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
  • Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
  • Umberto I Policlinico di Roma-Università di Roma La Sapienza
  • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
  • IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
  • IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
  • ASST DI MONZA; Neurologia
  • IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
  • AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
  • Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Yachiyo Hospital
  • Nagoya Ekisaikai Hospital
  • National Center for Geriatrics and Gerontology
  • Medical Corporation Hakuyokai Kashiwado Hospital
  • Tokyo Bay Advanced Medical and Makuhari Clinic
  • Inage Neurology and Memory Clinic
  • Juntendo University Urayasu Hospital
  • Fukuoka University Hospital
  • Southern Tohoku Medical Clinic
  • National Hospital Organization Hiroshima-Nishi Medical Center
  • Kobe University Hospital
  • Hyogo Prefectural HarimaHimeji General Medical Center
  • Tsukazaki Hospital
  • Matsui Dietary and Dementia Clinic
  • Kagawa Prefectural Central Hospital
  • Yuai Clinic
  • Shonan Kamakura General Hospital
  • Rakuwakai Otowa Hospital
  • Uji Takeda Hospital
  • Mishima Hospital
  • Okayama Kyokuto Hospital
  • Rijikai Medical Corporation Katayama Medical Clinic
  • MI Clinic
  • Kishiwada Tokushukai Hospital
  • National Hospital Organization Hizen Psychiatric Medical Center
  • NHO Shizuoka Institute of Epilepsy and Neurological Disorders
  • Shizuoka City Shimizu Hospital
  • Jichiidai Station Brain Clinic
  • Medical corporation Ichiekai Itsuki Hospital
  • Tokushima Hospital
  • Tokyo Medical and Dental University Hospital
  • Tokyo Medical University Hospital
  • Nozomi Memory Clinic
  • National Center of Neurology and Psychiatry
  • P-One Clinic
  • Yamagata Tokusyukai Hospital
  • Dong-A University Hospital
  • Myongji Hospital
  • Gachon University Gil Medical Center
  • Inha University Hospital
  • Seoul National University Bundang Hospital
  • Hanyang University Seoul Hospital
  • Konkuk University Medical Center
  • Asan Medical Center
  • Seoul St Mary's Hospital
  • Ewha Womans University Hospital (Seoul)
  • Samsung Medical Center
  • Vilnius University Hospital Santariskiu Clinics; Neurology
  • Mexico Centre for Clinical Research
  • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
  • Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta
  • AVIX Investigación Clínica S.C
  • Brain Research Center B.V
  • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
  • Clinica Internacional; Unidad De Investigacion
  • Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
  • O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
  • Podlaskie Centrum Psychogeriatrii
  • NZOZ Vitamed
  • KO-MED Centra Kliniczne Lublin II
  • Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna
  • mMED Maciej Czarnecki
  • Pratia S.A.
  • NZOZ WCA
  • Hospital de Braga; Servico de Neurologia
  • HUC; Servico de Neurologia
  • Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia
  • Hospital Geral de Santo Antonio; Servico de Neurologia
  • Santa Cruz Behavioral PSC
  • University of Puerto Rico - Medical Science Campus; Internal Medicine
  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
  • University ?linic of headaches
  • City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow
  • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
  • Vertebronevrologiya LLC
  • State autonomous institution of healthcare Inter-regional clinical and diagnostic center
  • City Clin Hosp n.a. S.P.Botkin
  • MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric
  • Nebbiolo Center for Clinical Trials
  • Hospital General Universitario de Elche; Servicio de Neurología
  • Hospital Universitari de Bellvitge; Servicio de Neurologia
  • Hospital General De Catalunya; Servicio de Neurologia
  • Hospital Mutua De Terrasa; Servicio de Neurologia
  • Hospital Virgen del Puerto. Servicio de Neurología
  • Hospital Universitario Marques de Valdecilla; Servicio de Neurología
  • Policlínica Guipuzcoa; Servicio de Neurología
  • Hospital San Pedro; Servicio de Neurología
  • Hospital Universitario de Santa Maria; Servicio de Neurología
  • HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Clinica Universitaria de Navarra; Servicio de Neurología
  • Clinica Universitaria de Navarra
  • Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
  • CAE OROITU; Servicio de Neurología
  • Hospital General Universitario de Albacete; Servicio de Neurología
  • Hospital del Mar; Servicio de Neurologia
  • Fundación ACE; Servicio de Neurología
  • Hospital Vall d'Hebron; Servicio de Neurología
  • Hospital Clinic i Provincial; Servicio de Neurologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Hospital Universitario Reina Sofia; Servicio de Neurologia
  • Universitario de La Princesa; Servicio de Neurología
  • Hospital Ramon y Cajal; Servicio de Neurologia
  • Hospital Ruber Internacional; Servicio de Neurología
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Hospital Virgen del Rocío; Servicio de Neurología
  • Hospital Victoria Eugenia; Servico Neurología
  • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Hospital Universitario la Fe; Servicio de Neurologia
  • Complejo Asistencial de Zamora; Servicio Psiquiatria
  • Servicio de Neurología Hospital Viamed Montecanal.
  • Skånes Universitetssjukhus Malmö, Minneskliniken
  • Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
  • KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
  • Changhua Christian Hospital; Neurology
  • Kaohsiung Medical University Hospital; Neurology
  • Chang Gung Memorial Foundation - Kaohsiung - Neurology
  • China Medical University Hospital; Neurology
  • National Taiwan University Hospital; Neurology
  • Chang Gung Memorial Foundation - Linkou - Neurology
  • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • The Rice Centre; Royal United Hospital
  • Re:Cognition Health Birmingham
  • The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
  • Surrey and Borders NHS Foundation Trust; Research and Development Department
  • Ninewells Hospital
  • Queen Elizabeth University Hospital - PPDS
  • St George?s Hospital
  • Re:Cognition Health London
  • Charing Cross Hospital
  • Campus for Ageing and Vitality
  • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust
  • University Southampton NHS Foundation Trust; Wessex Neurologica Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI
Percentage of Participants with Injection-Site Reactions (ISRs)

Secondary Outcome Measures

Change in Clinical Dementia Rating (CDR) Score
Change in Mini-Mental State Examination (MMSE) Score
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score
Change in Verbal Fluency Task Score
Change in Coding
Change in Functional Activities Questionnaire (FAQ) Score
Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score
Percentage of Participants with Anti-drug Antibody (ADA) to Gantenerumab

Full Information

First Posted
May 1, 2020
Last Updated
March 24, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04374253
Brief Title
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I&II (WN29922/WN39658).
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Percentage of Participants with Injection-Site Reactions (ISRs)
Time Frame
From Baseline (OLE Day 1) to Week 208
Secondary Outcome Measure Information:
Title
Change in Clinical Dementia Rating (CDR) Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Mini-Mental State Examination (MMSE) Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Verbal Fluency Task Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Coding
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Functional Activities Questionnaire (FAQ) Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score
Time Frame
From Baseline (OLE Day 1) to Week 208
Title
Percentage of Participants with Anti-drug Antibody (ADA) to Gantenerumab
Time Frame
From Baseline (OLE Day 1) to Week 208
Other Pre-specified Outcome Measures:
Title
Plasma Concentration of Gantenerumab Administered SC
Description
Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.
Time Frame
From Baseline (OLE Day 1) to Week 208

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Banner Alzheimer?s Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Banner Sun Health Research Insitute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Health Initiatives Research, PLLC
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Fullerton Neurology and Headache Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Desert Valley Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Sutter Medical Group, Neurology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Southern California Research LLC
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
JEM Research LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Accel Research Sites - CRU Tampa
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
ClinCloud, LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Optimus U Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Allied Biomedical Research Institute, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Intercoastal Medical Group
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Alzheimer?s Research and Treatment Center
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Southern Illinois University, School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
American Health Network Institute, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Missouri Memory Center
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center; Dept of Neurological Sciences
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-8440
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo; Center for Brain Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Research Institute of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Neurological Associates of Long Island, PC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
AD-CARE, University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Behavioral Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Alzheimer's Memory Center
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6520
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University; College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Abington Neurological Associates
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Kerwin Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Neurology Consultants of Dallas; Research Department
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Wasatch Clinical Research, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22906
Country
United States
Facility Name
Sentara Neurology Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
National Clinical Research Inc.-Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
UW Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Hospital Italiano
City
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Universidad Maimonides
City
Caba
ZIP/Postal Code
C1405BCK
Country
Argentina
Facility Name
Instituto Geriatrico Nuestra Señora de las Nieves
City
Capital Federal
ZIP/Postal Code
C1427CCP
Country
Argentina
Facility Name
CEN Centro Especializado en Neurociencias
City
Cordoba
ZIP/Postal Code
X5004FJF
Country
Argentina
Facility Name
Instituto Kremer
City
Córdoba
ZIP/Postal Code
X5004AOA
Country
Argentina
Facility Name
Instituto de Neurociencias San Agustín S.A.
City
La Plata
ZIP/Postal Code
B1902AVF
Country
Argentina
Facility Name
Fundación Scherbovsky; General Department
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
St Vincent's Hospital Sydney; Neurology
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Central Coast Neurosciences Research
City
Erina
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Southern Neurology
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Queen Elizabeth Hospital; Neurology
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Australian Alzheimer's Research Foundation
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
AZ Sint Blasius (Dendermonde)
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
City
Curitiba
State/Province
PR
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
Clinica Clinilive ltda
City
Maringa
State/Province
PR
ZIP/Postal Code
87013-250
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP_X; Neurologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
The Medical Arts Health Research Group - West Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7T 2Z3
Country
Canada
Facility Name
Parkwood Hospital; Geriatric Medicine
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
Facility Name
Devonshire Clinical Research
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
Center for Diagnosis and Research on Alzheimer's disease
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Psicomed Estudios Médicos
City
Antofagasta
ZIP/Postal Code
1270244
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Especialidades Medicas LYS
City
Santiago
ZIP/Postal Code
7560356
Country
Chile
Facility Name
Beijing Tian Tan Hospital,Capital Medical University
City
Beijing City
ZIP/Postal Code
100071
Country
China
Facility Name
Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet, Hukommelsesklinikken
City
Koebenhavn Oe
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Terveystalo Ruoholahti
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Itä-Suomen yliopisto, Kuopion kampus
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
CHU Amiens Hopital Sud; Neurologie
City
Amiens Cedex1
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital Avicenne; Centre de Recherche Clinique
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Facility Name
CHU de la Timone - Hopital d Adultes; Service de Neurologie
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Poitiers - Hopital La Miletrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHU Strasbourg Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Gerontopole; Centre de Recherche clinique
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
PANAKEIA - Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Forschungszentrum Ruhr
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Semmelweis University; Department of Neurology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41126
Country
Italy
Facility Name
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00179
Country
Italy
Facility Name
Umberto I Policlinico di Roma-Università di Roma La Sapienza
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
Country
Italy
Facility Name
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00186
Country
Italy
Facility Name
IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST DI MONZA; Neurologia
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Yachiyo Hospital
City
Aichi
ZIP/Postal Code
446-8510
Country
Japan
Facility Name
Nagoya Ekisaikai Hospital
City
Aichi
ZIP/Postal Code
454-8502
Country
Japan
Facility Name
National Center for Geriatrics and Gerontology
City
Aichi
ZIP/Postal Code
474-8511
Country
Japan
Facility Name
Medical Corporation Hakuyokai Kashiwado Hospital
City
Chiba
ZIP/Postal Code
260-8656
Country
Japan
Facility Name
Tokyo Bay Advanced Medical and Makuhari Clinic
City
Chiba
ZIP/Postal Code
261-0024
Country
Japan
Facility Name
Inage Neurology and Memory Clinic
City
Chiba
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
Juntendo University Urayasu Hospital
City
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Southern Tohoku Medical Clinic
City
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Facility Name
National Hospital Organization Hiroshima-Nishi Medical Center
City
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Kobe University Hospital
City
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Hyogo Prefectural HarimaHimeji General Medical Center
City
Hyogo
ZIP/Postal Code
670-8560
Country
Japan
Facility Name
Tsukazaki Hospital
City
Hyogo
ZIP/Postal Code
671-1227
Country
Japan
Facility Name
Matsui Dietary and Dementia Clinic
City
Hyogo
ZIP/Postal Code
673-0891
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Yuai Clinic
City
Kanagawa
ZIP/Postal Code
223-0059
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Facility Name
Uji Takeda Hospital
City
Kyoto
ZIP/Postal Code
611-0021
Country
Japan
Facility Name
Mishima Hospital
City
Niigata
ZIP/Postal Code
940-2302
Country
Japan
Facility Name
Okayama Kyokuto Hospital
City
Okayama
ZIP/Postal Code
703-8265
Country
Japan
Facility Name
Rijikai Medical Corporation Katayama Medical Clinic
City
Okayama
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
MI Clinic
City
Osaka
ZIP/Postal Code
560-0004
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Facility Name
National Hospital Organization Hizen Psychiatric Medical Center
City
Saga
ZIP/Postal Code
842-0192
Country
Japan
Facility Name
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
City
Shizuoka
ZIP/Postal Code
420-8688
Country
Japan
Facility Name
Shizuoka City Shimizu Hospital
City
Shizuoka
ZIP/Postal Code
424-0911
Country
Japan
Facility Name
Jichiidai Station Brain Clinic
City
Tochigi
ZIP/Postal Code
329-0403
Country
Japan
Facility Name
Medical corporation Ichiekai Itsuki Hospital
City
Tokushima
ZIP/Postal Code
770-0852
Country
Japan
Facility Name
Tokushima Hospital
City
Tokushima
ZIP/Postal Code
776-8585
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Nozomi Memory Clinic
City
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
P-One Clinic
City
Tokyo
ZIP/Postal Code
192-0071
Country
Japan
Facility Name
Yamagata Tokusyukai Hospital
City
Yamagata
ZIP/Postal Code
990-0834
Country
Japan
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Gyeonggi-do
ZIP/Postal Code
10475
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ewha Womans University Hospital (Seoul)
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Vilnius University Hospital Santariskiu Clinics; Neurology
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Mexico Centre for Clinical Research
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
AVIX Investigación Clínica S.C
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Brain Research Center B.V
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
City
Bellavista
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
Clinica Internacional; Unidad De Investigacion
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
City
Lima
ZIP/Postal Code
15003
Country
Peru
Facility Name
O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
City
?cinawa
ZIP/Postal Code
59-330
Country
Poland
Facility Name
Podlaskie Centrum Psychogeriatrii
City
Bia?ystok
ZIP/Postal Code
15-756
Country
Poland
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
NEURO-CARE Sp. z o.o. Sp. Komandytowa
City
Siemianowice ?l?skie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
City
Sopot
ZIP/Postal Code
81-855
Country
Poland
Facility Name
mMED Maciej Czarnecki
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Pratia S.A.
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
NZOZ WCA
City
Wroc?aw
ZIP/Postal Code
53-659
Country
Poland
Facility Name
Hospital de Braga; Servico de Neurologia
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
HUC; Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia
City
Guimarães
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Santa Cruz Behavioral PSC
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
University of Puerto Rico - Medical Science Campus; Internal Medicine
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
University ?linic of headaches
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
121467
Country
Russian Federation
Facility Name
City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117556
Country
Russian Federation
Facility Name
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Vertebronevrologiya LLC
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420047
Country
Russian Federation
Facility Name
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
City Clin Hosp n.a. S.P.Botkin
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric
City
Sartatov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Nebbiolo Center for Clinical Trials
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche; Servicio de Neurología
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari de Bellvitge; Servicio de Neurologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General De Catalunya; Servicio de Neurologia
City
Sant Cugat del Valles
State/Province
Barcelona
ZIP/Postal Code
8195
Country
Spain
Facility Name
Hospital Mutua De Terrasa; Servicio de Neurologia
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08222
Country
Spain
Facility Name
Hospital Virgen del Puerto. Servicio de Neurología
City
Plasencia
State/Province
Caceres
ZIP/Postal Code
10600
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
City
SANtander
State/Province
Cantabria
ZIP/Postal Code
39011
Country
Spain
Facility Name
Policlínica Guipuzcoa; Servicio de Neurología
City
Donostia-san Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital San Pedro; Servicio de Neurología
City
Logroño
State/Province
LA Rioja
ZIP/Postal Code
26006
Country
Spain
Facility Name
Hospital Universitario de Santa Maria; Servicio de Neurología
City
Lleida
State/Province
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
Hospital Quiron de Madrid; Servicio de Neurologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Neurología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
City
Salamaca
State/Province
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
CAE OROITU; Servicio de Neurología
City
Getxo
State/Province
Vizcaya
ZIP/Postal Code
48993
Country
Spain
Facility Name
Hospital General Universitario de Albacete; Servicio de Neurología
City
Albacete
Country
Spain
Facility Name
Hospital del Mar; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Fundación ACE; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Vall d'Hebron; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Neurologia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Universitario de La Princesa; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Ruber Internacional; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Virgen del Rocío; Servicio de Neurología
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Victoria Eugenia; Servico Neurología
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Dr. Peset; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Complejo Asistencial de Zamora; Servicio Psiquiatria
City
Zamora
ZIP/Postal Code
49021
Country
Spain
Facility Name
Servicio de Neurología Hospital Viamed Montecanal.
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Facility Name
Skånes Universitetssjukhus Malmö, Minneskliniken
City
Malmö
ZIP/Postal Code
211 46
Country
Sweden
Facility Name
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
City
Mölndal
ZIP/Postal Code
431 41
Country
Sweden
Facility Name
KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Changhua Christian Hospital; Neurology
City
Changhua County
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital; Neurology
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Chang Gung Memorial Foundation - Kaohsiung - Neurology
City
Niaosong Dist.
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital; Neurology
City
North Dist.
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital; Neurology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Foundation - Linkou - Neurology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ondokuz Mayis Univ. Med. Fac.; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
The Rice Centre; Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Re:Cognition Health Birmingham
City
Birmingham
ZIP/Postal Code
B16 8QQ
Country
United Kingdom
Facility Name
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
City
Cheltenham
ZIP/Postal Code
GL53 9DZ
Country
United Kingdom
Facility Name
Surrey and Borders NHS Foundation Trust; Research and Development Department
City
Chertsey
ZIP/Postal Code
KT16 9AU
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD12 9SY
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital - PPDS
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
St George?s Hospital
City
London
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
Facility Name
Re:Cognition Health London
City
London
ZIP/Postal Code
W1G 9RU
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Campus for Ageing and Vitality
City
Newcastle
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
University Southampton NHS Foundation Trust; Wessex Neurologica Centre
City
Southampton
ZIP/Postal Code
SO166YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

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