Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gantenerumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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
Sites / Locations
- Center for Neurosciences
- Global Clinical Trials; Irvine, CA
- Sutter Medical Group, Neurology
- Syrentis Clinical Research
- California Neuroscience Research Medical Group, Inc
- Research Center for Clinical Studies, Inc.
- JEM Research LLC
- Bradenton Research Center
- Brain Matters Research, Inc.
- Alzheimer?s Research and Treatment Center
- Columbus Memory Center
- Center for Advanced Research & Education
- Southern Illinois University, School of Medicine
- Fort Wayne Neurological Center
- Via Christi Research
- Precise Research Centers
- University of Mississippi Medical Center
- Advanced Memory Research Institute of NJ
- Neurological Associates of Long Island, PC
- Columbia University Medical Center
- Ohio State University; College of Medicine
- Abington Neurological Associates
- The Clinical Trial Center, LLC
- Drexel University; College of Medicine
- Coastal Neurology
- Senior Adults Specialty Research
- Neurology Consultants of Dallas; Research Department
- Wasatch Clinical Research, LLC
- University of Virginia
- Sentara Neurology Specialists
- Neurological Associates, Inc.
- National Clinical Research Inc.-Richmond
- UW Wisconsin-Madison
- 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
- Neuro Trials Victoria
- Australian Alzheimer's Research Foundation
- Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
- Instituto de Neurologia de Curitiba
- Clinica Clinilive ltda
- Hospital das Clinicas - UFRGS
- Clínica Dr. Norton Sayeg LTDA - EPP
- Hospital das Clinicas - FMUSP_X; Neurologia
- Medical Arts Health Research Group
- The Medical Arts Health Research Group - West Vancouver
- Parkwood Hospital; Geriatric Medicine
- Centre for Memory and Aging
- Sunnybrook Health Sciences Centre
- St. Michael'S Hospital
- Baycrest Health Sciences
- Devonshire Clinical Research
- Center for Diagnosis and Research on Alzheimer's disease
- Q & T Research Sherbrooke
- Alpha Recherche Clinique
- China-Japan Friendship Hospital
- Beijing Anding Hospital, Capital Medical University
- Beijing Tian Tan Hospital,Capital Medical University
- West China Hospital, Sichuan University
- The First Affiliated Hospital, Chongqing Medical University
- Fujian Medical University Union Hospital
- Guangdong Provincial People's Hospital; Breast
- Sun Yat-sen Memorial Hospital; Neurology
- Guangzhou First Municipal People's Hospital
- Sir Run Run Shaw Hospital
- The Second Affiliated Hospital, Zhejiang University
- Anhui Provincial Hospital
- The First Affiliated Hospital of Anhui Medical University
- The Second Affiliated Hospital to Nanchang University
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
- Zhongda Hospital Affiliated to Southeast University
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
- Huashan Hospital Affiliated to Fudan University
- Shanghai Mental Health Center
- Shanghai First People's Hospital
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- The University of Hong Kong-Shenzhen Hospital
- Tianjin Medical University General Hospital
- The First Affiliated Hospital of Wenzhou Medical College
- Northern Jangsu People's Hospital
- Henan Provincial People's Hospital
- 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
- St. Josef-Hospital, Klinik für Neurologie
- 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
- Medical Corporation Hakuyokai Kashiwado Hospital
- Inage Neurology and Memory Clinic
- Juntendo University Urayasu Hospital
- Southern Tohoku Medical Clinic
- Yuai Clinic
- Shonan Kamakura General Hospital
- Mishima Hospital
- NHO Shizuoka Institute of Epilepsy and Neurological Disorders
- Shizuoka City Shimizu Hospital
- Jichiidai Station Brain Clinic
- Yotsuya Medical Cube
- Tokyo Medical and Dental University Hospital
- Tokyo Medical University Hospital
- Tokyo Metropolitan Geriatric Hospital
- Nozomi Memory Clinic
- National Center of Neurology and Psychiatry
- P-One Clinic
- Yamagata Tokusyukai Hospital
- Vilnius University Hospital Santariskiu Clinics; Neurology
- Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
- Clinica Internacional; Unidad De Investigacion
- Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
- Hospital Nacional Cayetano Heredia; Servicio de Neurologia
- FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
- University ?linic of headaches
- Vertebronevrologiya LLC
- State autonomous institution of healthcare Inter-regional clinical and diagnostic center
- Central Clinical Hospital #2 N.A. Semashko OAO RJHD
- City Clin Hosp n.a. S.P.Botkin
- City Clinical Hospital # 2 n.a. V.I. Razumovsky
- Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
- Nebbiolo Center for Clinical Trials
- Hospital Universitari de Bellvitge; Servicio de Neurologia
- Hospital General De Catalunya; Servicio de Neurologia
- Hospital Universitario Marques de Valdecilla; Servicio de Neurología
- Hospital San Pedro; Servicio de Neurología
- HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
- Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
- Hospital General Universitario de Albacete; 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
- 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 Universitario Dr. Peset; Servicio de Neurologia
- Servicio de Neurología Hospital Viamed Montecanal.
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gantenerumab
Placebo
Arm Description
Gantenerumab will be administered as SC injections with gradual uptitration.
Placebo will be administered as SC injections with gradual uptitration.
Outcomes
Primary Outcome Measures
Change From Baseline to Week 116 in Global Outcome, as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SOB)
Secondary Outcome Measures
Change from Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score
Change from Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11)
Change from Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13)
Change from Baseline to Week 116 in Verbal Fluency Task Score
Change from Baseline to Week 116 in Coding
Change from Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
Change from Baseline to Week 116 in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Total Score
Percentage of Participants with Adverse Events
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 Magnetic Resonance Imaging (MRI)
Percentage of Participants with Injection-Site Reactions
Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab
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
Change from Baseline in Brain Tau Load as Measured by Tau PET Scan in a subset of participants up to Week 116
Change From Baseline in CSF Marker of Disease in a subset of participants - Total Tau up to Week 116
Change From Baseline in CSF Marker of Disease in a subset of participants - Phosphorylated Tau up to Week 116
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03444870
Brief Title
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 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
June 6, 2018 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
February 17, 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
Data Monitoring Committee
Yes
5. 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.
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1054 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gantenerumab
Arm Type
Experimental
Arm Description
Gantenerumab will be administered as SC injections with gradual uptitration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered as SC injections with gradual uptitration.
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Other Intervention Name(s)
RO4909832
Intervention Description
Gantenerumab will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as per the schedule specified in the respective arm.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 116 in Global Outcome, as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SOB)
Time Frame
Baseline Up to Week 116
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score
Time Frame
Baseline Up to Week 116
Title
Change from Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11)
Time Frame
Baseline Up to Week 116
Title
Change from Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13)
Time Frame
Baseline Up to Week 116
Title
Change from Baseline to Week 116 in Verbal Fluency Task Score
Time Frame
Baseline Up to Week 116
Title
Change from Baseline to Week 116 in Coding
Time Frame
Change from baseline to Week 116 in the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) coding subtest.
Title
Change from Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
Time Frame
Baseline Up to Week 116
Title
Change from Baseline to Week 116 in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Total Score
Time Frame
Baseline Up to Week 116
Title
Percentage of Participants with Adverse Events
Time Frame
Baseline up to end of study (week 164) or Week 35 (Open label extension)
Title
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame
Baseline up to Week 116 or Week 24 in Open label extension
Title
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Time Frame
Baseline up to end of study (week 164) or Week 35 (Open label extension)
Title
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI)
Time Frame
Baseline up to end of study (week 164) or Week 35 (Open label extension)
Title
Percentage of Participants with Injection-Site Reactions
Time Frame
Baseline up to end of study (week 164) or Week 35 (Open label extension)
Title
Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Time Frame
Baseline up to end of study (week 164) or Week 35 (Open label extension)
Title
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
Time Frame
Baseline Up to Week 116
Title
Change from Baseline in Brain Tau Load as Measured by Tau PET Scan in a subset of participants up to Week 116
Time Frame
Baseline Up to Week 116
Title
Change From Baseline in CSF Marker of Disease in a subset of participants - Total Tau up to Week 116
Time Frame
Baseline Up to Week 116
Title
Change From Baseline in CSF Marker of Disease in a subset of participants - Phosphorylated Tau up to Week 116
Time Frame
Baseline Up to Week 116
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
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Global Clinical Trials; Irvine, CA
City
Irvine
State/Province
California
ZIP/Postal Code
92614
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
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
JEM Research LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
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
Alzheimer?s Research and Treatment Center
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Columbus Memory Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
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
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
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
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
Ohio State University; College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
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
Drexel University; College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Coastal Neurology
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29935
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
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
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
Neurological Associates, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
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
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
Neuro Trials Victoria
City
Noble Park
State/Province
Victoria
ZIP/Postal Code
3174
Country
Australia
Facility Name
Australian Alzheimer's Research Foundation
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
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
Clínica Dr. Norton Sayeg LTDA - EPP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04534-011
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
Medical Arts Health Research Group
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
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
Centre for Memory and Aging
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael'S Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
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
Q & T Research Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
China-Japan Friendship Hospital
City
Beijing City
ZIP/Postal Code
100029
Country
China
Facility Name
Beijing Anding Hospital, Capital Medical University
City
Beijing City
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Tian Tan Hospital,Capital Medical University
City
Beijing City
ZIP/Postal Code
100071
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital, Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
ZIP/Postal Code
350001
Country
China
Facility Name
Guangdong Provincial People's Hospital; Breast
City
Guangzhou City
ZIP/Postal Code
510180
Country
China
Facility Name
Sun Yat-sen Memorial Hospital; Neurology
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou City
ZIP/Postal Code
310018
Country
China
Facility Name
The Second Affiliated Hospital, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
The Second Affiliated Hospital to Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Facility Name
Zhongda Hospital Affiliated to Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai City
ZIP/Postal Code
200025
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
The University of Hong Kong-Shenzhen Hospital
City
Shenzhen City
ZIP/Postal Code
518053
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Northern Jangsu People's Hospital
City
Yangzhou City
ZIP/Postal Code
225001
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
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
St. Josef-Hospital, Klinik für Neurologie
City
Bochum
ZIP/Postal Code
44791
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
Medical Corporation Hakuyokai Kashiwado Hospital
City
Chiba
ZIP/Postal Code
260-8656
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
Southern Tohoku Medical Clinic
City
Fukushima
ZIP/Postal Code
963-8052
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
Mishima Hospital
City
Niigata
ZIP/Postal Code
940-2302
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
Yotsuya Medical Cube
City
Tokyo
ZIP/Postal Code
102-0084
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
Tokyo Metropolitan Geriatric Hospital
City
Tokyo
ZIP/Postal Code
173-0015
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
Vilnius University Hospital Santariskiu Clinics; Neurology
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
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
Hospital Nacional Cayetano Heredia; Servicio de Neurologia
City
San Martin de Porres
ZIP/Postal Code
15102
Country
Peru
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
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
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
City Clin Hosp n.a. S.P.Botkin
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
City Clinical Hospital # 2 n.a. V.I. Razumovsky
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Nebbiolo Center for Clinical Trials
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
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 Universitario Marques de Valdecilla; Servicio de Neurología
City
SANtander
State/Province
Cantabria
ZIP/Postal Code
39011
Country
Spain
Facility Name
Hospital San Pedro; Servicio de Neurología
City
Logroño
State/Province
LA Rioja
ZIP/Postal Code
26006
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
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
City
Salamaca
State/Province
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital General Universitario de Albacete; Servicio de Neurología
City
Albacete
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
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 Universitario Dr. Peset; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Servicio de Neurología Hospital Viamed Montecanal.
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
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
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.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
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