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Trial record 1 of 1 for:    WN39658
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Safety and Efficacy 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. Identifier: NCT03443973
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 28, 2019
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's Disease Drug: Gantenerumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 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 : August 22, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 2, 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 matching to gantenerumab 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 Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Subscale Score [ Time Frame: Baseline up to Week 104 ]
  2. Change From Baseline to Week 104 in Mini-Mental State Examination (MMSE) Total Score [ 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 Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline to Week 104 ]
  6. 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. ]
  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 (AEs) [ Time Frame: Baseline up to end of study (up to Week 152) ]
  9. Percentage of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab [ Time Frame: Baseline up to end of study (up to Week 152) ]
  10. Plasma Concentration of Gantenerumab [ Time Frame: Pre-dose (0 hour [hr]) at Baseline (Day 1), Weeks 24, 52, 76; and at Weeks 2, 41, 103, 116, 152, early termination visit ]
  11. 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 ]
  12. 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 ]
  13. Change From Baseline in Cerebral Spinal Fluid (CSF) Marker of Disease in a Subset of Patients - Amyloid-beta 1−42 (Aβ1−42) up to Week 104 [ Time Frame: Baseline up to Week 104 ]
  14. 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 ]
  15. 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 ]
  16. 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.

  17. Change from Baseline to Week 104 in Instrumental Score [ Time Frame: Baseline Up to Week 104 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 [MCI])
  • Evidence of the AD pathological process, as confirmed by CSF or amyloid PET scan
  • Demonstrated abnormal memory function
  • MMSE score great 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 baseline 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.

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
  • At risk for suicide in the opinion of the investigator
  • Patients with evidence of folic acid deficiency
  • 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

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 identifier (NCT number): NCT03443973

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Contact: Reference Study ID Number: WN39658 888-662-6728 (U.S. and Canada)

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United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Barrow Neurological Institute Not yet recruiting
Phoenix, Arizona, United States, 85013
Noesis Pharma Clinical Trials Withdrawn
Phoenix, Arizona, United States, 85032
Mayo Clinic Not yet recruiting
Scottsdale, Arizona, United States, 85259
Banner Sun Health Research Insitute Recruiting
Sun City, Arizona, United States, 85351
University of Arizona Withdrawn
Tucson, Arizona, United States, 85724-5030
United States, Arkansas
Health Initiatives Research, PLLC Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Fullerton Neurology and Headache Center Recruiting
Fullerton, California, United States, 92835
Neurology Center of North Orange County Recruiting
Fullerton, California, United States, 92835
Behavioral Research Specialists, LLC Terminated
Glendale, California, United States, 91206
Irvine Center for Clinical Research Recruiting
Irvine, California, United States, 92614
UCLA - School of Medicine, VA Medical Center Not yet recruiting
Los Angeles, California, United States, 90073
Pacific Neuroscience Med Grp Active, not recruiting
Oxnard, California, United States, 93030
Desert Valley Research Recruiting
Rancho Mirage, California, United States, 92270
Pacific Research Network - PRN Recruiting
San Diego, California, United States, 92103
San Francisco Clinical Research Center Withdrawn
San Francisco, California, United States, 94109
Southern California Research LLC Recruiting
Simi Valley, California, United States, 93065
Collaborative Neuroscience Network Inc. Recruiting
Torrance, California, United States, 90502
United States, Connecticut
Associated Neurologists of Southern CT PC Recruiting
Fairfield, Connecticut, United States, 06824
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Care Health Service Not yet recruiting
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Georgetown University Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Global Medical Institues, LLC; Boynton Beach Medical Research Institute Recruiting
Boynton Beach, Florida, United States, 33437
Meridien Research Recruiting
Bradenton, Florida, United States, 34201
Meridien Research Recruiting
Brooksville, Florida, United States, 34601
Neuropsychiatric Research; Center of Southwest Florida Withdrawn
Fort Myers, Florida, United States, 33912
ClinCloud, LLC Recruiting
Maitland, Florida, United States, 32751
Optimus U Corp Recruiting
Miami, Florida, United States, 33125
Allied Biomedical Research Institute, Inc Recruiting
Miami, Florida, United States, 33155
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34470
Sensible Healthcare; Ocoee, FL Recruiting
Ocoee, Florida, United States, 34761
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Intercoastal Medical Group Recruiting
Sarasota, Florida, United States, 34232
Infinity Clinical Research, LLC Recruiting
Sunrise, Florida, United States, 33351
Axiom Clinical Research of Florida Recruiting
Tampa, Florida, United States, 33609
Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Augusta University Not yet recruiting
Augusta, Georgia, United States, 30912
iResearch Atlanta Withdrawn
Decatur, Georgia, United States, 30030
United States, Illinois
Rush Alzheimer's Disease Cntr. Not yet recruiting
Chicago, Illinois, United States, 60612
Chicago Research Center, Inc. Withdrawn
Chicago, Illinois, United States, 60634
Heathcare Research Network II, LLC Not yet recruiting
Flossmoor, Illinois, United States, 60422
Advocate Lutheran General Hospital Not yet recruiting
Park Ridge, Illinois, United States, 60068
United States, Indiana
American Health Network Institute, LLC Recruiting
Avon, Indiana, United States, 46123
United States, Kansas
University of Kansas Medical Centre Recruiting
Kansas City, Kansas, United States, 66160
Conduct Clinical Trials; Psychiatry Associates of Kansas City Withdrawn
Leawood, Kansas, United States, 66206
United States, Kentucky
University of Kentucky Not yet recruiting
Lexington, Kentucky, United States, 40536
Four Rivers Clinical Research Inc. Recruiting
Paducah, Kentucky, United States, 42003
United States, Maine
Acadia Hospital Not yet recruiting
Bangor, Maine, United States, 04401
United States, Maryland
University of Maryland Clinical Neurobehavioral Center Withdrawn
Columbia, Maryland, United States, 21045
United States, Massachusetts
Brigham and Womens Hospital; Center for Alzheimer Research & Treatment Recruiting
Boston, Massachusetts, United States, 02115
ActivMed Practices and Research Recruiting
Haverhill, Massachusetts, United States, 01830
Boston Center for Memory Recruiting
Newton, Massachusetts, United States, 02459
United States, Michigan
Quest Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Missouri Memory Center Recruiting
Bolivar, Missouri, United States, 65613
St Louis University Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center; Dept of Neurological Sciences Not yet recruiting
Omaha, Nebraska, United States, 68198-8440
United States, Nevada
Cleveland Clinic Lou Ruvo; Center for Brain Research Recruiting
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Memory Enhancement Center of America, Inc. Terminated
Eatontown, New Jersey, United States, 07724
The Cognitive and Research Center of New Jersey Recruiting
Springfield, New Jersey, United States, 07081
NJ Institute for Successful Aging Not yet recruiting
Stratford, New Jersey, United States, 08084
United States, New York
Integrative Clinical Trials LLC Recruiting
Brooklyn, New York, United States, 11229
Pioneer Midwood Withdrawn
Brooklyn, New York, United States, 11229
UNiversity of Rochester Recruiting
Rochester, New York, United States, 14620
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Behavioral Health Research Recruiting
Charlotte, North Carolina, United States, 28211
Alzheimer's Memory Center Recruiting
Charlotte, North Carolina, United States, 28270
Guilford Neurologic Associates Recruiting
Greensboro, North Carolina, United States, 27401
Raleigh Neurology Associates Recruiting
Raleigh, North Carolina, United States, 27607-6520
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals Brain Health & Memory Center Not yet recruiting
Beachwood, Ohio, United States, 44122
Neuro-Behavioral Clinical Research, Inc. Recruiting
Canton, Ohio, United States, 44718
Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health - Neurological Institute Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Clinical Research Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Summit Research Network Inc. Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Lehigh Center Clinical Research Recruiting
Allentown, Pennsylvania, United States, 18104
United States, South Carolina
University of South Carolina School of Medicine Recruiting
Columbia, South Carolina, United States, 29203-7606
BG Neurology, LLC Withdrawn
Spartanburg, South Carolina, United States, 29307
United States, Texas
Texas Neurology PA Recruiting
Dallas, Texas, United States, 75214
Kerwin Research Center, LLC Recruiting
Dallas, Texas, United States, 75231
The University of Texas Southwestern Medical Center at Dallas Not yet recruiting
Dallas, Texas, United States, 75390
Shepherd Healthcare Active, not recruiting
Flower Mound, Texas, United States, 75028
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77054
University of Texas Health Sciences Center in San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Aspen Clinical Research Withdrawn
Orem, Utah, United States, 84058
United States, Washington
Core Clinical Research Recruiting
Everett, Washington, United States, 98201
Seattle Institute for Biomedical & Clinical Research Not yet recruiting
Seattle, Washington, United States, 98108
Kingfisher Cooperative Recruiting
Spokane, Washington, United States, 99202
Hospital Italiano Recruiting
Buenos Aires, Argentina, C1181ACH
Universidad Maimonides Recruiting
Caba, Argentina, C1405BCK
Instituto Geriatrico Nuestra Señora de las Nieves Recruiting
Capital Federal, Argentina, C1427
CEN Centro Especializado en Neurociencias Recruiting
Córdoba, Argentina, 5000FJF
Instituto Kremer Recruiting
Córdoba, Argentina, X5004AOA
Instituto de Neurociencias San Agustín S.A. Recruiting
La Plata, Argentina, 1900
Fundación Scherbovsky Recruiting
Mendoza, Argentina, 5500
AZ Sint Blasius (Dendermonde) Recruiting
Dendermonde, Belgium, 9200
UZ Gent Recruiting
Gent, Belgium, 9000
Jessa Zkh (Campus Virga Jesse) Recruiting
Hasselt, Belgium, 3500
Clinique Saint-Joseph Recruiting
Liège, Belgium, 4000
Clinica Portal oriente; Psicomedica Recruiting
Antofagasta, Chile, 1270244
Biomedica Research Group Recruiting
Santiago, Chile, 7500710
Especialidades Medicas LYS Recruiting
Santiago, Chile, 7560356
Clinical Hospital Centre Zagreb;Clinic for Neurology Recruiting
Zagreb, Croatia, 10000
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken Recruiting
Aarhus N, Denmark, 8200
Rigshospitalet, Hukommelsesklinikken Recruiting
København Ø, Denmark, 2100
Odense Universitetshospital, Neurologisk Afd. N;Demensklinikken Recruiting
Odense C, Denmark, 5000
Terveystalo Ruoholahti Not yet recruiting
Helsinki, Finland, 00180
University of Eastern Finland Recruiting
Kuopio, Finland, 70210
CRST Oy Withdrawn
Turku, Finland, 20520
Yachiyo Hospital Recruiting
Aichi, Japan, 446-8510
Nagoya Ekisaikai Hospital Recruiting
Aichi, Japan, 454-8502
National Center for Geriatrics and Gerontology Recruiting
Aichi, Japan, 474-8511
Fukuoka University Hospital Recruiting
Fukuoka, Japan, 814-0180
National Hospital Organization Hiroshima-Nishi Medical Center Recruiting
Hiroshima, Japan, 739-0696
Kobe University Hospital Active, not recruiting
Hyogo, Japan, 650-0017
Hyogo Brain and Heart Center at Himeji Recruiting
Hyogo, Japan, 670-0981
Tsukazaki Hospital Recruiting
Hyogo, Japan, 671-1227
Matsui Dietary and Dementia Clinic Recruiting
Hyogo, Japan, 673-0891
Kagawa Prefectural Central Hospital Recruiting
Kagawa, Japan, 760-8557
Rakuwakai Otowa Hospital Recruiting
Kyoto, Japan, 607-8062
Uji Takeda Hospital Recruiting
Kyoto, Japan, 611-0021
Nara City Hospital Recruiting
Nara, Japan, 630-8305
Okayama Kyokuto Hospital Active, not recruiting
Okayama, Japan, 703-8265
Katayama Medical Clinic Recruiting
Okayama, Japan, 710-0813
MI Clinic Active, not recruiting
Osaka, Japan, 560-0004
Kishiwada Tokushukai Hospital Recruiting
Osaka, Japan, 596-0042
National Hospital Organization Hizen Psychiatric Center Recruiting
Saga, Japan, 842-0192
Medical corporation Ichiekai Itsuki Hospital Recruiting
Tokushima, Japan, 770-0852
Tokushima Hospital Recruiting
Tokushima, Japan, 776-8585
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Myongji Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 10475
Seoul National University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 13620
Bucheon St Mary's hospital Terminated
Gyeonggi-do, Korea, Republic of, 14647
Gachon University Gil Medical Center Not yet recruiting
Incheon, Korea, Republic of, 21565
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Hanyang University Seoul Hospital Not yet recruiting
Seoul, Korea, Republic of, 04763
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 05030
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 07985
Samsung Medical Center - Neurology Recruiting
Seoul, Korea, Republic of, 6351
Hospital Español; Servicio de Nuerologia Withdrawn
Ciudad de México, Mexico CITY (federal District), Mexico, 11550
Grupo Medico de Investigacion Clinica Multidisciplinaria Recruiting
Mexico City, Mexico CITY (federal District), Mexico, 03100
Unidad de investigacion en salud (UIS); Neurociencias Recruiting
Ciudad de México, Mexico, 14050
Hospital Angeles Culiacan; Neurociencias Recruiting
Culiacan, Mexico, 80020
Mexico Centre for Clinical Research Recruiting
Mexico, Mexico, 03100
Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; NeurologíaPta.BajaConsulta Recruiting
Monterrey, Mexico, 64460
AVIX Investigación Clínica S.C Recruiting
Monterrey, Mexico, 64710
Brain Research Center B.V Recruiting
Amsterdam, Netherlands, 1081 GN
Podlaskie Centrum Psychogeriatrii Recruiting
Białystok, Poland, 15-756
NZOZ Vitamed Recruiting
Bydgoszcz, Poland, 85-079
KO-MED Centra Kliniczne Lublin II Recruiting
Lublin, Poland, 20-362
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych Recruiting
Plewiska, Poland, 62-064
NEURO-CARE Sp. z o.o. Sp. Komandytowa Recruiting
Siemianowice Śląskie, Poland, 41-100
Senior Sp. Z O.O. Poradnia Psychogeriatryczna Recruiting
Sopot, Poland, 81-855
Pratia S.A. Recruiting
Warszawawa, Poland, 01-868
mMED Maciej Czarnecki Recruiting
Warszawa, Poland, 01-684
NZOZ WCA Recruiting
Wrocław, Poland, 53-659
Ośrodek Badawczo-Naukowo-Dydaktyczny Chorób Otępiennych w Ścinawie Recruiting
Ścinawa, Poland, 59-330
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia Recruiting
Amadora, Portugal, 2720-276
Hospital de Braga; Servico de Neurologia Recruiting
Braga, Portugal, 4710-243
HUC; Servico de Neurologia Recruiting
Coimbra, Portugal, 3000-075
Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia Recruiting
Guimarães, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia Recruiting
Porto, Portugal, 4099-001
Puerto Rico
Santa Cruz Behavioral PSC Recruiting
Bayamon, Puerto Rico, 00961
Instituto De Neurologia Dra. Ivonne Fraga, PSC Recruiting
San Juan, Puerto Rico, 00918-4502
Dr Michel A. Woodbury, PSC Not yet recruiting
San Juan, Puerto Rico, 00918
University of Puerto Rico - Medical Science Campus; Internal Medicine Recruiting
San Juan, Puerto Rico, 00936
National University Hospital (NUH); Neuroscience Recruiting
Singapore, Singapore, 117549
National Neuroscience Institute; Neurology Recruiting
Singapore, Singapore, 308433
Hospital General Universitario de Elche; Servicio de Neurología Recruiting
Elche, Alicante, Spain, 03203
Hospital Mutua De Terrasa; Servicio de Neurologia Recruiting
Terrassa, Barcelona, Spain, 08222
Hospital Virgen del Puerto. Servicio de Neurología Recruiting
Plasencia, Caceres, Spain, 10600
Policlínica Guipuzcoa; Servicio de Neurología Recruiting
Donostia-san Sebastian, Guipuzcoa, Spain, 20014
Hospital Universitario de Santa Maria; Servicio de Neurología Recruiting
Lleida, Lerida, Spain, 25198
Hospital Quiron de Madrid; Servicio de Neurologia Recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Clinica Universitaria de Navarra; Servicio de Neurología Recruiting
Pamplona, Navarra, Spain, 31008
CAE OROITU; Servicio de Neurología Active, not recruiting
Getxo, Vizcaya, Spain, 48993
Hospital del Mar; Servicio de Neurologia Recruiting
Barcelona, Spain, 08003
Instituto Internacional de Neurociencias Aplicadas (IINA); Servicio de Psiquiatría Recruiting
Barcelona, Spain, 08006
Fundación ACE; Servicio de Neurología Recruiting
Barcelona, Spain, 08028
Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría Recruiting
Barcelona, Spain, 08035
Hospital Universitario de Burgos. Servicio de Neurología Recruiting
Burgos, Spain, 09006
Universitario de La Princesa; Servicio de Neurología Recruiting
Madrid, Spain, 28006
Clinica Universitaria Navarra; Servicio Neurologia Not yet recruiting
Madrid, Spain, 28027
Hospital Victoria Eugenia; Servico Neurología Recruiting
Sevilla, Spain
Hospital Universitario la Fe; Servicio de Neurologia Recruiting
Valencia, Spain, 46026
Complejo Asistencial de Zamora; Servicio Psiquiatria Recruiting
Zamora, Spain, 49021
Skånes Universitetssjukhus Malmö, Minneskliniken Recruiting
Malmoe, Sweden, SE-20502
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry Recruiting
Mölndal, Sweden, 431 41
Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med Recruiting
Stockholm, Sweden, 14186
Istanbul Bilim Sisli UTF Recruiting
Esentepe, Turkey, 34394
Istanbul University Istanbul School of Medicine; Neurology Recruiting
Istanbul, Turkey, 34093
Bezmialem Vakif Univ Medical Recruiting
Istanbul, Turkey, 34286
Ondokuz Mayis Univ. Med. Fac.; Neurology Recruiting
Samsun, Turkey, 55139
United Kingdom
Royal Cornhill Hospital; OAP Directorate Active, not recruiting
Aberdeen, United Kingdom, AB25 2ZH
The Rice Centre; Royal United Hospital Recruiting
Bath, United Kingdom, BA1 3NG
Re-Cognition Recruiting
Birmingham, United Kingdom, B16 8QQ
MAC Clinical Research; Blackpool Not yet recruiting
Blackpool, United Kingdom, FY2 0JH
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre Recruiting
Cheltenham, United Kingdom, GL53 9DZ
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit Recruiting
Chertsey, United Kingdom, KT16 0AE
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit Recruiting
Crowborough, United Kingdom, TN6 1HB
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD12 9SY
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Queen Elizabeth University Hospital; Clinical Research Facility Recruiting
Glasgow, United Kingdom, G51 4TF
MAC Clinical Research; Leeds Not yet recruiting
Leeds, United Kingdom
St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
RE:Cognition Health Recruiting
London, United Kingdom, W1G 9RU
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Campus for Ageing and Vitality Recruiting
Newcastle Upon Tyne, United Kingdom, NE4 6BE
Tees,Esk and Wear Valleys NHS Foundation Trust Recruiting
North Yorkshire, United Kingdom, HG5 0UB
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Derriford Hospital; Neurology Recruiting
Plymouth, United Kingdom
MAC Clinical Research; Liverpool Not yet recruiting
Prescot, United Kingdom, L34 1BH
Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2JF
University Southampton NHS Foundation Trust; Wessex Neurologica Centre Recruiting
Southampton, United Kingdom, SO166YD
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

Additional Information:
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Responsible Party: Hoffmann-La Roche Identifier: NCT03443973     History of Changes
Other Study ID Numbers: WN39658
2017-001365-24 ( EudraCT Number )
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs