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Safety and Efficacy 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
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • 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
  • Southern California Research LLC
  • Yale University School Of Medicine
  • Georgetown University Medical Center
  • Accel Research Sites - CRU Tampa
  • ClinCloud, LLC
  • Optimus U Corp
  • Allied Biomedical Research Institute, Inc
  • Renstar Medical Research
  • Progressive Medical Research
  • Intercoastal Medical Group
  • Infinity Clinical Research, LLC
  • Axiom Clinical Research of Florida
  • Emory University
  • Rush Alzheimer's Disease Cntr.
  • American Health Network Institute, LLC
  • Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
  • ActivMed Practices and Research
  • Boston Center for Memory
  • Quest Research Institute
  • 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
  • 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
  • Neuro-Behavioral Clinical Research, Inc.
  • Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health - Neurological Institute
  • Lynn Health Science Institute
  • Summit Research Network Inc.
  • Texas Neurology PA
  • Kerwin Medical Center
  • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
  • The University of Texas Health Science Center at Houston
  • 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.
  • Fundacion Scherbovsky
  • AZ Sint Blasius (Dendermonde)
  • UZ Gent
  • Jessa Zkh (Campus Virga Jesse)
  • Psicomed Estudios Médicos
  • Biomedica Research Group
  • Especialidades Medicas LYS
  • Clinical Hospital Centre Zagreb;Clinic for Neurology
  • Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
  • Rigshospitalet, Hukommelsesklinikken
  • Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn
  • Terveystalo Ruoholahti
  • University of Eastern Finland
  • Yachiyo Hospital
  • Nagoya Ekisaikai Hospital
  • National Center for Geriatrics and Gerontology
  • Fukuoka University Hospital
  • National Hospital Organization Hiroshima-Nishi Medical Center
  • Hyogo Prefectural HarimaHimeji General Medical Center
  • Tsukazaki Hospital
  • Matsui Dietary and Dementia Clinic
  • Kagawa Prefectural Central Hospital
  • Rakuwakai Otowa Hospital
  • Uji Takeda Hospital
  • Rijikai Medical Corporation Katayama Medical Clinic
  • Kishiwada Tokushukai Hospital
  • National Hospital Organization Hizen Psychiatric Medical Center
  • Medical corporation Ichiekai Itsuki Hospital
  • Tokushima 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)
  • Ewha Womans University Mokdong Hospital
  • Samsung Medical Center
  • Mexico Centre for Clinical Research
  • Hospital Angeles Culiacan; Neurociencias
  • Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta
  • AVIX Investigación Clínica S.C
  • Brain Research Center B.V
  • 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
  • Ośrodek Badawczo-Naukowo-Dydaktyczny Chorób Otępiennych w Ścinawie
  • Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
  • 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
  • National University Hospital (NUH); Neuroscience
  • National Neuroscience Institute; Neurology
  • Hospital General Universitario de Elche; Servicio de Neurología
  • Hospital Mutua De Terrasa; Servicio de Neurologia
  • Hospital Virgen del Puerto. Servicio de Neurología
  • Policlínica Guipuzcoa; Servicio de Neurología
  • Hospital Universitario de Santa Maria; Servicio de Neurología
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Clinica Universitaria de Navarra; Servicio de Neurología
  • Clinica Universitaria de Navarra
  • CAE OROITU; Servicio de Neurología
  • Hospital del Mar; Servicio de Neurologia
  • Fundación ACE; Servicio de Neurología
  • Universitario de La Princesa; Servicio de Neurología
  • Hospital Victoria Eugenia; Servico Neurología
  • Hospital Universitario la Fe; Servicio de Neurologia
  • Complejo Asistencial de Zamora; Servicio Psiquiatria
  • Skånes Universitetssjukhus Malmö, Minneskliniken
  • Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
  • KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
  • Istanbul University Istanbul School of Medicine; Neurology
  • Bezmialem Vakif Univ Medical
  • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Royal Cornhill Hospital; OAP Directorate
  • The Rice Centre; Royal United Hospital
  • Re-Cognition
  • The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
  • Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
  • Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
  • Ninewells Hospital
  • Queen Elizabeth University Hospital; Clinical Research Facility
  • St George's Hospital
  • RE:Cognition Health
  • Charing Cross Hospital
  • Campus for Ageing and Vitality
  • John Radcliffe Hospital
  • Royal Preston Hospital
  • 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

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) Subscale Score
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 (AEs)
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 Antibodies (ADA) to Gantenerumab
Change from Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a subset of patients up to Week 116
Change From Baseline in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Patients up to Week 116
Change From Baseline in CSF Marker of Disease in a Subset of Patients - Total Tau up to Week 116
Change From Baseline in CSF Marker of Disease in a Subset of Patients - Phosphorylated Tau up to Week 116

Full Information

First Posted
February 19, 2018
Last Updated
January 6, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03443973
Brief Title
Safety and Efficacy 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
January 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
August 22, 2018 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
November 28, 2022 (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
982 (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 matching to gantenerumab 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) Subscale Score
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 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 (AEs)
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 Antibodies (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 patients 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 Patients up to Week 116
Time Frame
Baseline up to Week 116
Title
Change From Baseline in CSF Marker of Disease in a Subset of Patients - 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 Patients - Phosphorylated Tau up to Week 116
Time Frame
Baseline up to Week 116
Other Pre-specified Outcome Measures:
Title
Plasma Concentration of Gantenerumab
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
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
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
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Accel Research Sites - CRU Tampa
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
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
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
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
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Rush Alzheimer's Disease Cntr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
American Health Network Institute, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
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
ActivMed Practices and Research
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
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
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
Neuro-Behavioral Clinical Research, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
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
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Texas Neurology PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Facility Name
Kerwin Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
C1181ACH
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
Fundacion Scherbovsky
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
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
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
Clinical Hospital Centre Zagreb;Clinic for Neurology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Aarhus Universitetshospital, Neurologisk Afdeling 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
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
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
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
National Hospital Organization Hiroshima-Nishi Medical Center
City
Hiroshima
ZIP/Postal Code
739-0696
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
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
Rijikai Medical Corporation Katayama Medical Clinic
City
Okayama
ZIP/Postal Code
710-0813
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
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
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
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
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 Culiacan; Neurociencias
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
Podlaskie Centrum Psychogeriatrii
City
Białystok
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 Śląskie
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
Wrocław
ZIP/Postal Code
53-659
Country
Poland
Facility Name
Ośrodek Badawczo-Naukowo-Dydaktyczny Chorób Otępiennych w Ścinawie
City
Ścinawa
ZIP/Postal Code
59-330
Country
Poland
Facility Name
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
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
National University Hospital (NUH); Neuroscience
City
Singapore
ZIP/Postal Code
117549
Country
Singapore
Facility Name
National Neuroscience Institute; Neurology
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital General Universitario de Elche; Servicio de Neurología
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
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
Policlínica Guipuzcoa; Servicio de Neurología
City
Donostia-san Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
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
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
CAE OROITU; Servicio de Neurología
City
Getxo
State/Province
Vizcaya
ZIP/Postal Code
48993
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
Universitario de La Princesa; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Victoria Eugenia; Servico Neurología
City
Sevilla
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
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
Istanbul University Istanbul School of Medicine; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Bezmialem Vakif Univ Medical
City
Istanbul
ZIP/Postal Code
34286
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Royal Cornhill Hospital; OAP Directorate
City
Aberdeen
ZIP/Postal Code
AB25 2ZH
Country
United Kingdom
Facility Name
The Rice Centre; Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Re-Cognition
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; Brain Science Research Unit
City
Chertsey
ZIP/Postal Code
KT16 9AU
Country
United Kingdom
Facility Name
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
City
Crowborough
ZIP/Postal Code
TN6 1HB
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD12 9SY
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital; Clinical Research Facility
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
RE:Cognition Health
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
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
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.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

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

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