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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444870
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Gantenerumab Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1016 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 3, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gantenerumab
Gantenerumab will be administered as SC injections with gradual uptitration.
Drug: Gantenerumab
Gantenerumab will be administered as per the schedule specified in the respective arm.
Other Name: RO4909832

Placebo Comparator: Placebo
Placebo will be administered as SC injections with gradual uptitration.
Drug: Placebo
Placebo will be administered as per the schedule specified in the respective arm.




Primary Outcome Measures :
  1. Change From Baseline to Week 104 in Global Outcome, as Measured by Clinical Dementia Rating−Sum of Boxes (CDR-SOB) [ Time Frame: Baseline Up to Week 104 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 104 in Mini-Mental State Examination (MMSE) Total Score [ Time Frame: Baseline Up to Week 104 ]
  2. Change from Baseline to Week 104 in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) [ Time Frame: Baseline Up to Week 104 ]
  3. Change from Baseline to Week 104 in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) [ Time Frame: Baseline Up to Week 104 ]
  4. Change from Baseline to Week 104 in Verbal Fluency Task Score [ Time Frame: Baseline Up to Week 104 ]
  5. Change from Baseline to Week 104 in Coding [ Time Frame: Change from baseline to Week 104 in the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) coding subtest. ]
  6. Change from Baseline to Week 104 in Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline Up to Week 104 ]
  7. Change from Baseline to Week 104 in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Total Score [ Time Frame: Baseline Up to Week 104 ]
  8. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to end of study (week 152) or Week 35 (Open label extension) ]
  9. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline up to Week 104 or Week 24 in Open label extension ]
  10. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline up to end of study (week 152) or Week 35 (Open label extension) ]
  11. Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline up to end of study (week 152) or Week 35 (Open label extension) ]
  12. Percentage of Participants with Injection-Site Reactions [ Time Frame: Baseline up to end of study (week 152) or Week 35 (Open label extension) ]
  13. Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab [ Time Frame: Baseline up to end of study (week 152) or Week 35 (Open label extension) ]
  14. Plasma Concentration of Gantenerumab Administered SC [ Time Frame: Baseline, Week 2, 24, 41, 52, 76, 103, 116, 152, and at early termination and unscheduled visit, Week 1 and Week 24 (Open label extension) ]
  15. Change from Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a subset of patients up to Week 104 [ Time Frame: Baseline Up to Week 104 ]
  16. Change from Baseline in Brain Tau Load as Measured by Tau PET Scan in a subset of patients up to Week 104 [ Time Frame: Baseline Up to Week 104 ]
  17. Change From Baseline in Cerebral Spinal Fluid (CSF) Marker of Disease in a subset of patients - Amyloidbeta 1−42 (Aβ1−42) up to Week 104 [ Time Frame: Baseline Up to Week 104 ]
  18. Change From Baseline in CSF Marker of Disease in a subset of patients - Total Tau up to Week 104 [ Time Frame: Baseline Up to Week 104 ]
  19. Change From Baseline in CSF Marker of Disease in a subset of patients - Phosphorylated Tau up to Week 104 [ Time Frame: Baseline Up to Week 104 ]
  20. Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI) up to Week 104 [ Time Frame: Baseline Up to Week 104 ]
    MRI will be used to assess the effect of treatment on volume of whole brain, ventricles, hippocampus, or other structures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 104 MRI scan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444870


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: WN29922 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) Global-Roche-Genentech-Trials@gene.com

Locations
Hide Hide 238 study locations
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United States, Arizona
Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
United States, California
CITrials, Inc. Withdrawn
Bellflower, California, United States, 90706
Global Clinical Trials; Irvine, CA Completed
Irvine, California, United States, 92614
Excell Research Withdrawn
Oceanside, California, United States, 92056
ASCLEPES Research Centers Withdrawn
Panorama City, California, United States, 91402
CITrials, Inc. Withdrawn
Riverside, California, United States, 92506
Sutter Medical Group, Neurology Active, not recruiting
Sacramento, California, United States, 95816
University of California, Davis; Alzheimers Disease Center, Department of Neurology Withdrawn
Sacramento, California, United States, 95817
Syrentis Clinical Research Active, not recruiting
Santa Ana, California, United States, 92705
North Bay Neuro Science Institute Withdrawn
Sebastopol, California, United States, 95472
California Neuroscience Research Medical Group, Inc Active, not recruiting
Sherman Oaks, California, United States, 91403
Upland Clinical Research Withdrawn
Upland, California, United States, 91789
United States, Connecticut
Coastal Connecticut Research, Llc Withdrawn
New London, Connecticut, United States, 06320
Research Center for Clinical Studies, Inc. Active, not recruiting
Norwalk, Connecticut, United States, 06851
Comprehensive Psychiatric Care Withdrawn
Norwich, Connecticut, United States, 06360
United States, Florida
JEM Research LLC Recruiting
Atlantis, Florida, United States, 33462
Bradenton Research Center Active, not recruiting
Bradenton, Florida, United States, 34205
Clinical Research of South Florida Withdrawn
Coral Gables, Florida, United States, 33134
Brain Matters Research, Inc. Recruiting
Delray Beach, Florida, United States, 33445
SIH Research Withdrawn
Kissimmee, Florida, United States, 34759
Combined Research Orlando Phase I-IV Withdrawn
Orlando, Florida, United States, 32807
Global Medical Institues, LLC; Central Miami Medical Institute Withdrawn
South Miami, Florida, United States, 33143
Alzheimer's Research and Treatment Center Recruiting
Wellington, Florida, United States, 33414
United States, Georgia
Atlanta Center For Medical Research Withdrawn
Atlanta, Georgia, United States, 30331
Columbus Memory Center Recruiting
Columbus, Georgia, United States, 31909
Center for Advanced Research & Education Active, not recruiting
Gainesville, Georgia, United States, 30501
United States, Illinois
University of Chicago; Neurology Withdrawn
Chicago, Illinois, United States, 60637
Southern Illinois University, School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Neuropsychiatric Research Withdrawn
Winfield, Illinois, United States, 60190
United States, Indiana
Fort Wayne Neurological Center Active, not recruiting
Fort Wayne, Indiana, United States, 46805
Josephson Wallack Munshower Neurology PC Withdrawn
Indianapolis, Indiana, United States, 46256
United States, Kansas
Via Christi Research Recruiting
Wichita, Kansas, United States, 67214
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Galen Clinical Research Withdrawn
Chesterfield, Missouri, United States, 63005
United States, New Jersey
NeuroCognitive Institute Withdrawn
Mount Arlington, New Jersey, United States, 07856
Advanced Memory Research Institute of NJ Recruiting
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County, PA Withdrawn
West Long Branch, New Jersey, United States, 07764
United States, New York
Neurological Associates of Long Island, PC Active, not recruiting
Lake Success, New York, United States, 11042
Weill Cornell Memory Disorders Withdrawn
New York, New York, United States, 10021
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Richard H Weisler, MD Withdrawn
Raleigh, North Carolina, United States, 27609
United States, Ohio
Ohio State University; College of Medicine Active, not recruiting
Columbus, Ohio, United States, 43210
UC Health Neurology Withdrawn
Dayton, Ohio, United States, 45417
United States, Oregon
Oregon Center for Clinical Investigations, Inc Withdrawn
Portland, Oregon, United States, 97210
Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center Withdrawn
Portland, Oregon, United States, 97239
United States, Pennsylvania
The Clinical Trial Center, LLC Recruiting
Jenkintown, Pennsylvania, United States, 19046
Drexel University; College of Medicine Completed
Philadelphia, Pennsylvania, United States, 19102
Abington Neurological Associates Active, not recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Medical University of South Carolina Withdrawn
Charleston, South Carolina, United States, 29425
Coastal Neurology Active, not recruiting
Port Royal, South Carolina, United States, 29935
United States, Tennessee
University of Tennessee Medical Center Withdrawn
Knoxville, Tennessee, United States, 37920
Clinical Research Associates Withdrawn
Nashville, Tennessee, United States, 37203
United States, Texas
FutureSearch Trials, LP Withdrawn
Austin, Texas, United States, 78731
Senior Adults Specialty Research Recruiting
Austin, Texas, United States, 78757
Neurology Consultants of Dallas; Research Department Recruiting
Dallas, Texas, United States, 75243
University Hills Clinical Research Withdrawn
Irving, Texas, United States, 75062
United States, Utah
Wasatch Clinical Research, LLC Active, not recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
University of Virginia Active, not recruiting
Charlottesville, Virginia, United States, 22906
Sentara Neurology Specialists Recruiting
Norfolk, Virginia, United States, 23510
Neurological Associates, Inc. Completed
Richmond, Virginia, United States, 23229
National Clinical Research Inc.-Richmond Active, not recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Northwest Clinical Research Center Withdrawn
Bellevue, Washington, United States, 98007
United States, Wisconsin
UW Wisconsin-Madison Active, not recruiting
Madison, Wisconsin, United States, 53705
Australia, New South Wales
St Vincent's Hospital Sydney; Neurology Recruiting
Darlinghurst, New South Wales, Australia, 2010
Central Coast Neurosciences Research Recruiting
Erina, New South Wales, Australia, 2250
Southern Neurology Recruiting
Kogarah, New South Wales, Australia, 2217
Calvary Mater Newcastle Completed
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Queensland University of Technology Completed
Mermaid Waters, Queensland, Australia, 4218
Australia, South Australia
The Queen Elizabeth Hospital; Neurology Recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
Peninsula Therapeutic & Research Group Completed
Frankston, Victoria, Australia, 3199
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre Recruiting
Heidelberg West, Victoria, Australia, 3081
HammondCare Aged Psychiatry Clinical Trials Withdrawn
Malvern, Victoria, Australia, 3144
Neuro Trials Victoria Recruiting
Noble Park, Victoria, Australia, 3174
Australia, Western Australia
Australian Alzheimer's Research Foundation Recruiting
Nedlands, Western Australia, Australia, 6009
Brazil
CCBR - Brasilia Withdrawn
Brasilia, DF, Brazil, 70200-730
Flumignano Instituto de Medicina Active, not recruiting
Curitiba, PR, Brazil, 80045-120
Hospital Nossa Senhora das Graças; Centro de Pesquisas em Neurologia Recruiting
Curitiba, PR, Brazil, 80810-040
Instituto de Neurologia de Curitiba Active, not recruiting
Curitiba, PR, Brazil, 81210-310
Clinica Clinilive ltda Recruiting
Maringa, PR, Brazil, 87013-250
Instituto de Psiquiatria - UFRJ Withdrawn
Rio de Janeiro, RJ, Brazil, 22290-140
Hospital das Clinicas - UFRGS Recruiting
Porto Alegre, RS, Brazil
Universidade Federal de São Carlos Withdrawn
Sao Carlos, SP, Brazil, 13565-905
Universidade Federal de Sao Paulo - UNIFESP; Neurologia Active, not recruiting
Sao Paulo, SP, Brazil, 04024-002
Clínica Dr. Norton Sayeg LTDA - EPP Recruiting
Sao Paulo, SP, Brazil, 04534-011
Hospital das Clinicas - FMUSP; Neurologia Active, not recruiting
Sao Paulo, SP, Brazil, 05403-000
Canada, British Columbia
The Med Arts Health Rsrch Grp Withdrawn
Kelowna, British Columbia, Canada, V1Y 3G8
Medical Arts Health Research Group Active, not recruiting
Penticton, British Columbia, Canada, V1Y 1Z9
The Medical Arts Health Research Group Withdrawn
Powell River, British Columbia, Canada, V8A 3B6
Vancouver Hospital - UBC Hospital Site Withdrawn
Vancouver, British Columbia, Canada, V6Z 1Y6
The Medical Arts Health Research Group Active, not recruiting
Vancouver, British Columbia, Canada, V7T 2Z3
Vancouver Island Health Authority Withdrawn
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
True North Clinical Research-Halifax Withdrawn
Halifax, Nova Scotia, Canada, B3S 1M7
Canada, Ontario
Parkwood Hospital; Geriatric Medicine Recruiting
London, Ontario, Canada, N6C 5J1
The Centre for Memory and Aging Completed
Toronto, Ontario, Canada, M4G 3E8
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
St. Michael'S Hospital Active, not recruiting
Toronto, Ontario, Canada, M5B 1W8
Toronto Western Hospital Withdrawn
Toronto, Ontario, Canada, M5T 2S8
Baycrest Centre for Geriatric Care Recruiting
Toronto, Ontario, Canada, M6A 2E1
Devonshire Clinical Research Inc. Active, not recruiting
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
Center for Diagnosis and Research on Alzheimer's disease Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Institute Universitaire de Geriatrie de Montreal Withdrawn
Montréal, Quebec, Canada, H3W 1W5
CHA Hopital de I enfant-Jesus Withdrawn
Quebec City, Quebec, Canada, G1J 1Z4
Q & T Research Sherbrooke Active, not recruiting
Sherbrooke, Quebec, Canada, J1J 2G2
Canada, Saskatchewan
Royal University Hospital Withdrawn
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
ALPHA Recherche Clinique Active, not recruiting
Quebec, Canada, G3K 2P8
China
Peking Union Medical College Hospital Recruiting
Beijing City, China, 100032
China-Japan Friendship Hospital Not yet recruiting
Beijing, China, 10029
Beijing Tian Tan Hospital,Capital Medical University Active, not recruiting
Beijing, China
West China Hospital, Sichuan University Recruiting
Chengdu, China, 610041
Fujian Medical University Union Hospital Not yet recruiting
Fujian, China, 350001
Sun Yat-sen Memorial Hospital; Neurology Not yet recruiting
Guangzhou, China, 510000
Guangdong General Hospital Not yet recruiting
Guangzhou, China, 510080
Guangzhou First Municipal People's Hospital Not yet recruiting
Guangzhou, China, 510180
Sir Run Run Shaw Hospital Not yet recruiting
Hangzhou, China, 310016
The First Affiliated Hospital of Anhui Medical University Not yet recruiting
Hefei, China, 230022
The Second Affiliated Hospital to Nanchang University Not yet recruiting
Nanchang, China, 330006
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) Not yet recruiting
Nanjing City, China, 210029
Huashan Hospital Affiliated to Fudan University Not yet recruiting
Shanghai City, China, 200040
Shanghai First People's Hospital Not yet recruiting
Shanghai, China, 200080
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China, 200092
Tianjin Medical University General Hospital Recruiting
Tianjin (天津), China, 300052
The First Affiliated Hospital of Wenzhou Medical College Not yet recruiting
Wenzhou, China, 325000
Zhongnan Hospital of Wuhan University Not yet recruiting
Wuhan, China, 430071
Tangdu Hospital, The Fourth Military Medical University; Neurology Department Withdrawn
Xi'an, China
Henan Provincial People's Hospital Not yet recruiting
Zhengzhou, China, 450003
Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Withdrawn
Barranquilla, Colombia, 080020
Hospital Universitario San Ignacio Withdrawn
Bogota, Colombia, 000472
France
CHU Amiens Hopital Sud; Neurologie Recruiting
Amiens Cedex1, France, 80054
CHU Angers Withdrawn
Angers, France, 49933
Hôpital Avicenne; Centre de Recherche Clinique Active, not recruiting
Bobigny Cedex, France, 93009
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie Withdrawn
Bordeaux, France, 33076
Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U102) Recruiting
Bron cedex, France, 69677
CHU de la Timone - Hopital d Adultes; Service de Neurologie Recruiting
Marseille, France, 13005
Hôpital Lariboisière Recruiting
Paris, France, 75475
CH Pitie Salpetriere; IM2A Withdrawn
Paris, France, 75651
CHU Poitiers - Hopital La Miletrie Recruiting
Poitiers, France, 86000
CHU Strasbourg - Hôpital Hautepierre Recruiting
Strasbourg, France, 67098
Gerontopole; Centre de Recherche clinique Recruiting
Toulouse, France, 31059
Hopital des Charpennes Recruiting
Villeurbanne, France, 69100
Germany
Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin Active, not recruiting
Berlin, Germany, 12200
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic Recruiting
Berlin, Germany, 13125
St. Josef-Hospital, Klinik für Neurologie Active, not recruiting
Bochum, Germany, 44791
Universitätsklinikum Düsseldorf; Neurologische Klinik Active, not recruiting
Düsseldorf, Germany, 40225
NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich Active, not recruiting
Erbach/Odenwald, Germany, 64711
Universitätsklinikum Essen, Elisabeth-Krankenhaus, Klinik für Geriatrie, Haus Berge, Contilia GmbH Withdrawn
Essen, Germany, 45356
Universitätsklinikum Hamburg-Eppendorf Zentrum f.Psychosoz.Medizin Klinik f.Psychiatrie Withdrawn
Hamburg, Germany, 20246
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie Active, not recruiting
Homburg/Saar, Germany, 66421
Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie Active, not recruiting
Köln, Germany, 50937
PANAKEIA - Arzneimittelforschung Leipzig GmbH Recruiting
Leipzig, Germany, 04275
Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi Recruiting
Mainz, Germany, 55131
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie Recruiting
München, Germany, 81675
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie Active, not recruiting
Münster, Germany, 48149
Universitätsklinikum Rostock Zentrum für Nervenheilkunde Recruiting
Rostock, Germany, 18147
ZNS Siegen im MVZ Weidenau Suspended
Siegen, Germany, 57076
Universitätsklinikum Ulm; Klinik für Neurologie Recruiting
Ulm, Germany, 89081
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz Active, not recruiting
Westerstede, Germany, 26655
Forschungszentrum Ruhr Active, not recruiting
Witten, Germany, 58455
Hungary
Semmelweis University; Department of Neurology Recruiting
Budapest, Hungary, 1083
Italy
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze Active, not recruiting
Modena, Emilia-Romagna, Italy, 41126
Policlinico Universitario Agostino Gemelli; UOC Neurologia Active, not recruiting
Roma, Lazio, Italy, 00168
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica Recruiting
Roma, Lazio, Italy, 00179
Umberto I Policlinico di Roma-Università di Roma La Sapienza Active, not recruiting
Roma, Lazio, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia Recruiting
Roma, Lazio, Italy, 00186
Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia Withdrawn
Genova, Liguria, Italy, 16128
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer Active, not recruiting
Brescia, Lombardia, Italy, 25125
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria Recruiting
Milano, Lombardia, Italy, 20132
Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative Withdrawn
Milano, Lombardia, Italy, 20144
ASST DI MONZA; Neurologia Recruiting
Monza, Lombardia, Italy, 20900
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA Active, not recruiting
Pozzilli, Molise, Italy, 86077
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria Active, not recruiting
Torino, Piemonte, Italy, 10126
Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Active, not recruiting
Palermo, Sicilia, Italy, 90127
Japan
Medical Corporation Hakuyokai Kashiwado Hospital Active, not recruiting
Chiba, Japan, 260-8656
National Hospital Organization Chiba-East Hospital Withdrawn
Chiba, Japan, 260-8712
Tokyo Bay Advanced Medical and Makuhari Clinic Recruiting
Chiba, Japan, 261-0024
Inage Neurology and Memory Clinic Recruiting
Chiba, Japan, 263-0043
Juntendo University Urayasu Hospital Active, not recruiting
Chiba, Japan, 279-0021
Southern Tohoku Medical Clinic Active, not recruiting
Fukushima, Japan, 963-8052
Yuai Clinic Recruiting
Kanagawa, Japan, 223-0059
Shonan Kamakura General Hospital Active, not recruiting
Kanagawa, Japan, 247-8533
Mishima Hospital Active, not recruiting
Niigata, Japan, 940-2302
NHO Shizuoka Institute of Epilepsy and Neurological Disorders Active, not recruiting
Shizuoka, Japan, 420-8688
Shizuoka City Shimizu Hospital Active, not recruiting
Shizuoka, Japan, 424-0911
Jichiidai Station Brain Clinic Active, not recruiting
Tochigi, Japan, 329-0403
Yotsuya Medical Cube Active, not recruiting
Tokyo, Japan, 102-0084
Tokyo Medical & Dental University Hospital Recruiting
Tokyo, Japan, 113-8519
Tokyo Medical University Hospital Recruiting
Tokyo, Japan, 160-0023
Shinjuku Research Park Clinic Withdrawn
Tokyo, Japan, 169-0073
Tokyo Metropolitan Geriatric Hospital Active, not recruiting
Tokyo, Japan, 173-0015
Nozomi Memory Clinic Active, not recruiting
Tokyo, Japan, 181-0013
National Center of Neurology and Psychiatry Active, not recruiting
Tokyo, Japan, 187-8551
P-One Clinic Active, not recruiting
Tokyo, Japan, 192-0071
Yamagata Tokusyukai Hospital Recruiting
Yamagata, Japan, 990-0834
Lithuania
Vilnius University Hospital Santariskiu Clinics; Neurology Active, not recruiting
Vilnius, Lithuania, 08661
Peru
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion Recruiting
Bellavista, Peru, Callao 2
Clinica Internacional; Unidad De Investigacion Recruiting
Lima, Peru, 15001
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia Recruiting
Lima, Peru, 15018
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional Withdrawn
Lima, Peru, Lima 41
Hospital Nacional Cayetano Heredia; Servicio de Neurologia Terminated
San Martin de Porres, Peru, 15102
Russian Federation
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency Recruiting
Krasnoyarsk, Krasnojarsk, Russian Federation, 660037
University сlinic of headaches Active, not recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 121467
Republican clinical hospital of regenerative treatment of Ministry of Health of Tatarstan republic Active, not recruiting
Kazan, Russian Federation, 420021
State autonomous institution of healthcare Inter-regional clinical and diagnostic center Recruiting
Kazan, Russian Federation, 420101
Central Clinical Hospital #2 N.A. Semashko OAO RJHD Recruiting
Moscow, Russian Federation, 107150
City Clin Hosp n.a. S.P.Botkin Recruiting
Moscow, Russian Federation, 125101
Samara Psychiatric Hospital Withdrawn
Samara, Russian Federation, 443016
City Clinical Hospital # 2 n.a. V.I. Razumovsky Active, not recruiting
Saratov, Russian Federation, 410028
City Psychiatric Hospital #3 of Skvortsov-Stepanov Withdrawn
St Petersburg, Russian Federation, 197341
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department Recruiting
St. Petersburg, Russian Federation, 194044
SBHI SR Region Specialized Psychiatric Hospital #2 Withdrawn
Stavropol, Russian Federation, 357034
Nebbiolo Center for Clinical Trials Recruiting
Tomsk, Russian Federation, 634009
Llc Lion-Med Withdrawn
Voronezh, Russian Federation, 394052
Spain
Hospital Universitari de Bellvitge; Servicio de Neurologia Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital General De Catalunya; Servicio de Neurologia Recruiting
Sant Cugat del Valles, Barcelona, Spain, 8195
Hospital Universitario Marques de Valdecilla; Servicio de Neurología Recruiting
Santander, Cantabria, Spain
UVaMID Hospital Santa Caterina;; Servicio de Neurología Withdrawn
Salt, Girona, Spain, 17090
Hospital San Pedro; Servicio de Neurología Recruiting
Logroño, LA Rioja, Spain, 26006
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría Recruiting
Móstoles, Madrid, Spain, 28938
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría Recruiting
Salamaca, Salamanca, Spain, 37007
Hospital General Universitario de Albacete; Servicio de Neurología Recruiting
Albacete, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia Recruiting
Barcelona, Spain, 08025
Hospital Universitari Quiron Dexeus;; Servicio Neurología Withdrawn
Barcelona, Spain, 08028
Hospital Vall d'Hebron; Servicio de Neurología Recruiting
Barcelona, Spain, 08035
Hospital Clinic i Provincial; Servicio de Neurologia Recruiting
Barcelona, Spain, 08036
Hospital Universitario Reina Sofia; Servicio de Neurologia Recruiting
Cordoba, Spain, 14011
Hospital Ramon y Cajal; Servicio de Neurologia Recruiting
Madrid, Spain, 28034
Hospital Ruber Internacional; Servicio de Neurología Recruiting
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Neurologia Active, not recruiting
Madrid, Spain, 28041
Hospital Virgen del Rocío; Servicio de Neurología Recruiting
Sevilla, Spain, 41013
Hospital Universitario Dr. Peset; Servicio de Neurologia Recruiting
Valencia, Spain, 46017
Servicio de Neurología Hospital Viamed Montecanal. Recruiting
Zaragoza, Spain, 50012
Taiwan
Changhua Christian Hospital; Neurology Active, not recruiting
Changhua County, Taiwan, 500
Kaohsiung Medical University Hospital; Neurology Recruiting
Kaohsiung, Taiwan, 807
Chang Gung Memorial Foundation - Kaohsiung - Neurology Recruiting
Niaosong Dist., Taiwan, 83301
China Medical University Hospital; Neurology Active, not recruiting
Taichung, Taiwan
National Taiwan University Hospital; Neurology Recruiting
Taipei, Taiwan, 100
Taipei Veterans General Hospital-Neurology Withdrawn
Taipei, Taiwan, 11217
Chang Gung Memorial Foundation - Linkou - Neurology Recruiting
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Additional Information:
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03444870    
Other Study ID Numbers: WN29922
2017-001364-38 ( EudraCT Number )
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders