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A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD) (CREAD 2)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114657
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : October 4, 2019
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 crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Crenezumab Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 806 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 Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : June 11, 2019
Actual Study Completion Date : June 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crenezumab
Participants will receive IV infusion of crenezumab q4w for 100 weeks.
Drug: Crenezumab
Crenezumab will be administered as IV infusion q4w for 100 weeks.

Placebo Comparator: Placebo
Participants will receive IV infusion of placebo q4w for 100 weeks.
Drug: Placebo
Placebo will be administered as IV infusion q4w for 100 weeks.




Primary Outcome Measures :
  1. Change from Baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score [ Time Frame: Baseline, Week 105 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 105 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) and Alzheimer's Disease Assessment Scale-Cognition 11 (ADAS-Cog-11) Subscale Score [ Time Frame: Baseline, Week 105 ]
  2. Change from Baseline to Week 105 in Clinical Dementia Rating-Global Score (CDR-GS) and Mini Mental State Exam MMSE [ Time Frame: Baseline, Week 105 ]
  3. Change from Baseline to Week 105 on Function as assessed by (ADCS-ADL) Total Score and Its (ADCS-iADL) and by the Functional Activities Questionnaire (FAQ) total score [ Time Frame: Baseline, Week 105 ]
  4. Change from Baseline to Week 105 on a Measure of Dependence Level Assessed from the ADCS-ADL Score [ Time Frame: Baseline, Week 105 ]
  5. Change from Baseline to Week 105 on Behavior in Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Score [ Time Frame: Baseline, Week 105 ]
  6. Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score [ Time Frame: Baseline, Week 105 ]
  7. Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score [ Time Frame: Baseline, Week 105 ]
  8. European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores [ Time Frame: Baseline, Week 105 ]
  9. Percentage of Participants with Adverse Event (AEs) and Serious Adverse Event (SAEs) [ Time Frame: Baseline up to Week 105 ]
  10. Percentage of Participants with Anti-Crenezumab Antibodies [ Time Frame: Baseline up to Week 105 ]
  11. Serum Concentration of Crenezumab [ Time Frame: Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 5, 13, 37, 53, and 100 (infusion length = as per the Pharmacy Manual) ]
  12. Plasma Amyloid Beta (Abeta) Concentrations [ Time Frame: Screening (Weeks -8 to -1) ; Day 1 Week 1; Weeks 5, 25, 53, and 100 ]
  13. Change from Baseline to Week 105 in Brain Volume as Determined by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 105 ]
  14. Cerebrospinal Fluid (CSF) concentration of Crenezumab [ Time Frame: At pre-defined intervals from baseline through week 105 ]
  15. Brain Amyloid Load Over Time Measured by Amyloid-PET [ Time Frame: At pre-defined intervals from baseline through week 105 ]
  16. Brain Tau Load Over Time Measured by Tau-PET [ Time Frame: At pre-defined intervals from baseline through week 105 ]
  17. Cerebrospinal Fluid (CSF) Markers of Disease Over Time [ Time Frame: At pre-defined intervals from baseline through week 105 ]


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 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight between 40 and 120 kilograms (kg), inclusive
  • Availability of a person (referred to as the "caregiver") who in the investigator's judgment : (a) Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities; (b) Is in sufficiently good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the study duration
  • Fluency in the language of the tests used at the study site
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
  • Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid (1-42) test system or amyloid positron emission tomography (PET) scan by qualitative read by the core/central PET laboratory
  • Demonstrated abnormal memory function at early screening (up to 4 weeks before screening begins) or at screening
  • Evidence of retrospective decline confirmed by a diagnosis verification form
  • Mild symptomatology, as defined by a screening MMSE score of >=22 points and CDR-GS of 0.5 or 1.0
  • 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])
  • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening. If the participant is taking medical food supplements, these must also have been stable for 3 months prior to screening
  • Participant must have completed at least 6 years of formal education after the age of 5 years
  • For enrollment into the China Extension Phase, participants must have residence in mainland China, Hong Kong or Taiwan and be of Chinese ancestry

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition, including but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington's disease, normal pressure hydrocephalus, seizure disorder, or hypoxia
  • Seizure history that, in the opinon of the investigator, is likely to results in cognitive impairment
  • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
  • At risk of suicide in the opinion of the investigator
  • Presence of significant cerebral vascular pathology as assessed by MRI central reader
  • Unstable or clinically significant cardiovascular, kidney or liver disease
  • Uncontrolled hypertension
  • Screening hemoglobin A1c (HbA1C) greater than (>) 8 percent (%)
  • Clinical significant sleep apnea that may be contributing to cognitive impairment. Sleep apnea, which in the clinical judgement of the investigator is adequately treated is allowed
  • Poor peripheral venous access
  • History of cancer except if considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy
  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins

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): NCT03114657


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Locations
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United States, Arizona
Imaging End Points Clinical Research
Scottsdale, Arizona, United States, 85258
Radiant Research, Inc.
Tempe, Arizona, United States, 85282
United States, Arkansas
Health Initiatives Research, PLLC
Fayetteville, Arkansas, United States, 72703
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
Clinical Trials Inc.
Little Rock, Arkansas, United States, 72205
United States, California
The Research Center of Southern California, LLC
Carlsbad, California, United States, 92011
ATP Clinical Research, Inc
Costa Mesa, California, United States, 92626
Senior Clinical Trials
Laguna Hills, California, United States, 92653
Uci Medical Center
Orange, California, United States, 92868
Neuro-Therapeutics Inc.
Pasadena, California, United States, 91105
Desert Valley Medical Group
Rancho Mirage, California, United States, 92270
Anderson Clinical Research, Inc.
Redlands, California, United States, 92374
University of California, Davis; Alzheimers Disease Center, Department of Neurology
Sacramento, California, United States, 95817
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
UCSF - Memory and Aging Center
San Francisco, California, United States, 94158
United States, Colorado
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112
MCB Clinical Research Centers
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20057
United States, Florida
JEM Research LLC
Atlantis, Florida, United States, 33462
Bradenton Research Center
Bradenton, Florida, United States, 34205
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33449
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Renstar Medical Research
Ocala, Florida, United States, 34470
Bioclinica Research
Orlando, Florida, United States, 32806
Neurology Associates Of Ormond Beach
Ormond Beach, Florida, United States, 32174
Progressive Medical Research
Port Orange, Florida, United States, 32127
Meridien Research
Saint Petersburg, Florida, United States, 33709
United States, Georgia
Columbus Memory Center
Columbus, Georgia, United States, 31909
United States, Hawaii
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Southern Illinois University, School of Medicine
Springfield, Illinois, United States, 62702
United States, Kansas
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States, 70601
United States, Massachusetts
McLean Hospital; First Episode Clinic
Belmont, Massachusetts, United States, 02478
Alzheimers Disease Center; Neurology
Winchester, Massachusetts, United States, 01890
United States, Minnesota
Health Partners Institute for Education and Research
Saint Paul, Minnesota, United States, 55130
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Nebraska
University of Nebraska Medical Center; Dept of Neurological Sciences
Omaha, Nebraska, United States, 68198-8440
United States, Nevada
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States, 89106
United States, New Jersey
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States, 07081
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States, 08755
United States, New York
State University of New York at Buffalo; Department of Neurology
Buffalo, New York, United States, 14203
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center; Monroe Community Hospital
Rochester, New York, United States, 14627
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
United States, North Carolina
Behavioral Health Research
Charlotte, North Carolina, United States, 28211
Guilford Neurologic Associates
Greensboro, North Carolina, United States, 27401
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Ohio Clinical Research Partners, LLC
Canton, Ohio, United States, 44718
Dayton Center for Neuro Disorders
Centerville, Ohio, United States, 45459
Carl and Edyth Lindner Center at Christ Hospital
Cincinnati, Ohio, United States, 45011
University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219
Ohio State University; College of Medicine
Columbus, Ohio, United States, 43210
United States, Oklahoma
Ips Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States, 19403
Drexel Univ College of Med; Clinical Research Group
Philadelphia, Pennsylvania, United States, 19102
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Northeastern Pennsylvania Memory
Plains, Pennsylvania, United States, 18705
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Tennessee
Neurology Clinic PC
Cordova, Tennessee, United States, 38018
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Gadolin Research, LLC
Beaumont, Texas, United States, 77702
Texas Neurology PA
Dallas, Texas, United States, 75214
Kerwin Research Center, LLC
Dallas, Texas, United States, 75231
InSite Clinical Research
DeSoto, Texas, United States, 75115
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston, Texas, United States, 77030
Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
United States, Virginia
Sentara Medical Group
Norfolk, Virginia, United States, 23507
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States, 23294
United States, Washington
Frontier Institute
Spokane, Washington, United States, 99204
Argentina
Hospital Italiano
Buenos Aires, Argentina, C1181ACH
Universidad Maimonides
Caba, Argentina, C1405BCK
Hospital Sirio Libanes
Caba, Argentina, C1419AHN
DAMIC
Cordoba, Argentina, X500 3DCE
Australia, New South Wales
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Central Coast Neurosciences Research
Erina, New South Wales, Australia, 2250
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
Hornsby, New South Wales, Australia, 2077
Australia, South Australia
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, Australia, 5011
Australia, Victoria
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research
Fitzroy, Victoria, Australia, 3065
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, Australia, 3081
Royal Melbourne Hospital; Department of Neurology
Parkville, Victoria, Australia, 3050
Belgium
AZ Sint Jan
Brugge, Belgium, 8000
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Brazil
CCBR - Brasilia
Brasilia, DF, Brazil, 70200-730
Hospital das Clinicas - UFMG
Belo Horizonte, MG, Brazil, 31270-901
Instituto de Neurologia de Curitiba
Curitiba, PR, Brazil, 81210-310
Centro Psiquiatria Sandra Ruschel Ltda
Rio de Janeiro, RJ, Brazil, 22270-060
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Clínica Dr. Norton Sayeg LTDA - EPP
Sao Paulo, SP, Brazil, 04063-001
Canada, British Columbia
Okanagan Clinical Trials
Kelowna, British Columbia, Canada, V1Y 1Z9
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
True North Clinical Research-Halifax
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Kentville
Kentville, Nova Scotia, Canada, B4N 5E3
Canada, Ontario
Jbn Medical Diagnostic Services Inc.
Burlington, Ontario, Canada, L7M 4Y1
Providence Care; Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Parkwood Hospital; Geriatric Medicine
London, Ontario, Canada, N6C 5J1
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada, K9H 2P4
The Centre for Memory and Aging
Toronto, Ontario, Canada, M4G 3E8
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1N9
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
Clinique NeuroOutaouais
Gatineau, Quebec, Canada, J8Y 1W2
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada, J4V 2J2
Canada
ALPHA Recherche Clinique
Quebec, Canada, G3K 2P8
China
Peking University Sixth Hospital; Department of Psychiatry
Beijing, China, 100083
Beijing Union Hospital
Beijing, China, 100730
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, China, 200025
Shanghai Mental Health Center
Shanghai, China, 200030
Tianjin Medical University General Hospital
Tianjin (天津), China, 300052
Denmark
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
Aarhus N, Denmark, 8200
Rigshospitalet, Hukommelsesklinikken
København Ø, Denmark, 2100
Estonia
Laane-Tallinna Keskhaigla
Tallinn, Estonia, 10617
France
Hopital Pellegrin; Cmrr Aquitaine
Bordeaux, France, 33076
Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie
Colmar, France, 68000
Hopital Roger Salengro; Service de Neurologie
Lille, France
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
Limoges, France, 87042
Hopital Broca
Paris, France, 75013
CH Pitie Salpetriere; IM2A
Paris, France, 75651
Hôpital Maison Blanche
Reims, France, 51092
CHU Rennes - Hopital Pontchaillou
Rennes cedex 09, France, 35033
CHU de Rouen Hopital; Service de Neurologie
Rouen, France, 76031
Hop Guillaume Et Rene Laennec; Cmrr St Herblain
St Herblain, France, 44800
Hopital des Charpennes
Villeurbanne, France, 69100
Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, Germany, 13125
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
Frankfurt, Germany, 60528
Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie
Freiburg, Germany, 79106
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
Homburg/Saar, Germany, 66421
AFL Arzneimittelforschung Leipzig GmbH
Leipzig, Germany, 04107
Pharmakologisches Studienzentrum
Mittweida, Germany, 09648
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, Germany, 81675
Greece
Naval Hospital of Athen;Neurology Clinic
Athens, Greece, 11521
Israel
Rambam Medical Center
Haifa, Israel, 0031096
Sheba Medical Center; Psychiatry Department
Ramat Gan, Israel, 5262100
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv, Israel, 6423906
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
Roma, Lazio, Italy, 00133
Policlinico Universitario Agostino Gemelli; UOC Neurologia
Roma, Lazio, Italy, 00168
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Roma, Lazio, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Roma, Lazio, Italy, 00186
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
Brescia, Lombardia, Italy, 25125
Irccs Multimedica Santa Maria; Unita' Di Neurologia
Castellanza, Lombardia, Italy, 21053
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
Milano, Lombardia, Italy, 20132
Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia
Milano, Lombardia, Italy, 20133
Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
Milano, Lombardia, Italy, 20148
Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
Passirana, Lombardia, Italy, 20017
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Pozzilli, Molise, Italy, 86077
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
Torino, Piemonte, Italy, 10126
A.O. Universitaria Pisana; Neurologia
Pisa, Toscana, Italy, 56126
Japan
National Center for Geriatrics and Gerontology
Aichi, Japan, 474-8511
Hirosaki University Hospital
Aomori, Japan, 036-8563
Inage Neurology and Memory Clinic
Chiba, Japan, 263-0043
Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, Japan, 739-0696
Sapporo Medical University Hospital
Hokkaido, Japan, 060-8543
Tsukazaki Hospital
Hyogo, Japan, 671-1227
Iwate Medical University Hospital
Iwate, Japan, 020-8505
Kagawa Prefectural Central Hospital
Kagawa, Japan, 760-8557
Fujisawa City Hospital
Kanagawa, Japan, 251-8550
National Hospital Organization Sagamihara National Hospital
Kanagawa, Japan, 252-0392
Koseikai Takeda Hospital
Kyoto, Japan, 600-8558
Ijinkai Takeda General Hospital
Kyoto, Japan, 601-1495
Rakuwakai Otowarehabilitation Hospital
Kyoto, Japan, 607-8113
National Hospital Organization Matsumoto Medical Center
Nagano, Japan, 399-8701
Saigata Medical Center
Niigata, Japan, 949-3193
Katayama Medical Clinic
Okayama, Japan, 710-0813
AMC Nishi Umeda Clinic
Osaka, Japan, 530-0001
Osaka Red Cross Hospital
Osaka, Japan, 543-8555
Osaka General Medical Center
Osaka, Japan, 558-8558
Osaka University Hospital
Osaka, Japan, 565-0871
Asakayama General Hospital
Osaka, Japan, 590-0018
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Japan, 420-8688
Showa University East Hospital
Tokyo, Japan, 142-0054
Ebara Hospital
Tokyo, Japan, 145-0065
Kanto Central Hospital
Tokyo, Japan, 158-8531
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Shinjuku Research Park Clinic
Tokyo, Japan, 169-0073
Tokyo Metropolitan Geriatric Hospital
Tokyo, Japan, 173-0015
National Center of Neurology and Psychiatry
Tokyo, Japan, 187-8551
Tokyo Medical University Hachioji Medical Center
Tokyo, Japan, 193-0998
Tottori University Hospital
Tottori, Japan, 683-8504
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 49201
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Hanyang University Seoul Hospital
Seoul, Korea, Republic of, 04763
Konkuk University Medical Center
Seoul, Korea, Republic of, 05030
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Seoul St Mary's Hospital
Seoul, Korea, Republic of, 06591
Borame Medical Center
Seoul, Korea, Republic of, 07061
Samsung Medical Center
Seoul, Korea, Republic of, 6351
Mexico
Investigacion Biomedica Elemental. Sapi de Cv
Guadalajara, Jalisco, Mexico, 44890
Hospital General de México
Mexico City, Mexico CITY (federal District), Mexico, 06726
Estimulacion Magnetica Trnscraneal de Mexico SC.
Mexico City, Mexico, 11000
Centro de Estudios Clinicos y Especialidades Médicas, S.C.
Monterrey, Mexico, 64620
Centro De Atencion E Investigacion Cardiovascular Del Potosi S.C.
San Luis Potosí, Mexico, 78200
Norway
Akershus universitetssykehus HF; Nevroklinikken S203
Lørenskog, Norway, 1478
Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken
Oslo, Norway, 0450
Peru
Clinica Internacional; Unidad De Investigacion
Lima, Peru, 15001
Clinica Anglo Americana; Centro de Investigacion Neurologia II CAA
Lima, Peru, Lima 27
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Lima, Peru
Poland
NZOZ Dom Sue Ryder
Bydgoszcz, Poland, 85-023
Centrum Medyczne Euromedis Sp. z o.o.
Szczecin, Poland, 70-111
Centrum Medyczne NeuroProtect
Warszawa, Poland, 01-684
NZOZ WCA
Wrocław, Poland, 53-659
Portugal
Hospital de Braga; Servico de Neurologia
Braga, Portugal, 4710-243
HUC; Servico de Neurologia
Coimbra, Portugal, 3000-075
Hospital Pedro Hispano; Servico de Neurologia
Matosinhos, Portugal, 4464-513
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, Portugal, 4099-001
Russian Federation
LLC Baltic Medicine
Saint-Petersburg, Sankt Petersburg, Russian Federation, 194356
State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita
Yekaterinburg, Sverdlovsk, Russian Federation, 620030
Republican clinical hospital of regenerative treatment of Ministry of Health of Tatarstan republic
Kazan, Russian Federation, 420021
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan, Russian Federation, 420101
Institution of RAMS (Mental Health Research Center of RAMS)
Moscow, Russian Federation, 115522
City Clinical Psychiatry Hospital #1
Nizhny Novgorod, Russian Federation, 603155
St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy
St Petersburg, Russian Federation, 190121
Nebbiolo Center for Clinical Trials
Tomsk, Russian Federation, 634009
Serbia
Clinic for Mental disorders Dr Laza Lazarevic
Belgrade, Serbia, 11000
Neurology clinic, Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinic for neurology, Clinical Center Kragujevac
Kragujevac, Serbia, 34000
South Africa
Flexivest Fourteen Research Centre
Cape Town, South Africa, 7550
Private Practice; the Osteoporosis Clinic
Johannesburg, South Africa, 2196
Spain
Hospital General Universitario de Elche; Servicio de Neurología
Elche, Alicante, Spain, 03203
Fundació ACE
BArcelon, Barcelona, Spain, 08034
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Valles, Barcelona, Spain, 8195
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrassa, Barcelona, Spain, 08222
Hospital Virgen del Puerto. Servicio de Neurología
Plasencia, Caceres, Spain, 10600
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
Santander, Cantabria, Spain
Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies
Salt, Girona, Spain, 17090
Policlínica Guipuzkoa; Servicio de Neurología
Donosti-San Sebastián, Guipuzcoa, Spain, 20014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital San Pedro; Servicio de Neurología
Logroño, LA Rioja, Spain, 26006
Hospital Universitario de Getafe; Servicio de Geriatria
Getafe, Madrid, Spain, 28905
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcon, Madrid, Spain, 28223
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarra, Spain, 31008
CAE Oroitu
BaraKaldo, Vizcaya, Spain, 48903
Hospital Perpetuo Socorro, Servicio de Geriatria
Albacete, Spain, 2006
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, Spain, 08025
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, Spain, 08036
Hospital Universitario de Burgos. Servicio de Neurología
Burgos, Spain, 09006
Hospital la Magdalena; Servicio de Neurologia
Castellon, Spain, 12004
Hospital Universitario Reina Sofia; Servicio de Neurologia
Cordoba, Spain, 14011
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, Spain, 28034
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla
Salamanca, Spain, 37005
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla, Spain, 41009
Hospital Clínico Universitario de Valladolid; Servicio de Neurología
Valladolid, Spain, 47010
Sweden
Skånes Universitetssjukhus Malmö, Minneskliniken
Malmoe, Sweden, SE-20502
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
Mölndal, Sweden, 431 41
Taiwan
Changhua Christian Hospital; Neurology
Changhua County, Taiwan, 500
Kaohsiung Medical University Hospital; Neurology
Kaohsiung, Taiwan, 807
Chang Gung Memorial Foundation - Kaohsiung - Neurology
Kaohsiung, Taiwan, 83301
Taipei Medical University - Shuang Ho Hospital - Neurology
New Taipei City, Taiwan, 23561
National Taiwan University Hospital; Neurology
Taipei, Taiwan, 100
Chang Gung Memorial Foundation - Linkou - Neurology
Taoyuan, Taiwan, 333
Turkey
Ankara University School of Medicine; Neurology
Ankara, Turkey, 06100
Hacettepe University Medical Faculty; Neurology
Ankara, Turkey, 06100
Akdeniz University School of Medicine, Neurology Department
Antalya, Turkey, 07058
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, Turkey, 34093
Kocaeli University Hospital; Department of Neurology
Kocaeli, Turkey, 41380
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, Turkey, 55139
United Kingdom
The Rice Centre; Royal United Hospital
Bath, United Kingdom, BA1 3NG
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
Cheltenham, United Kingdom, GL53 9DZ
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
Chertsey, United Kingdom, KT16 0AE
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
Crowborough, United Kingdom, TN6 1HB
Ninewells Hospital
Dundee, United Kingdom, DD12 9SY
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Queen Elizabeth University Hospital; Clinical Research Facility
Glasgow, United Kingdom, G51 4TF
Crosshouse Hospital; NHS Ayrshire & Arran
Kilmarnock, United Kingdom, KA2 0BE
Royal Liverpool and Broadgreen University Hospital Trust
L7 8xp, United Kingdom
RE:Cognition Health
London, United Kingdom, W1G 9RU
Charing Cross Hospital; Imperial Memory Unit, Level 10 West
London, United Kingdom, W6 8RF
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
University Southampton NHS Foundation Trust; Wessex Neurologica Centre
Southampton, United Kingdom, SO166YD
University Hospital North Midlands
Stoke on Trent, United Kingdom, ST4 6QG
Re:Cognition Health Guildford
Surrey, United Kingdom, GU2 7YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03114657     History of Changes
Other Study ID Numbers: BN29553
2016-003288-20 ( EudraCT Number )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs