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Trial record 1 of 1 for:    NCT03114657
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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)

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ClinicalTrials.gov Identifier: NCT03114657
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : October 4, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 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
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : October 28, 2022

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.


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


Contacts
Contact: Reference Study ID Number: BN29553 www.roche.com/about_roche/ roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
United States, Arizona
Imaging End Points Clinical Research Active, not recruiting
Scottsdale, Arizona, United States, 85258
Radiant Research, Inc. Terminated
Tempe, Arizona, United States, 85282
University of Arizona Withdrawn
Tucson, Arizona, United States, 85724-5030
United States, Arkansas
Health Initiatives Research, PLLC Active, not recruiting
Fayetteville, Arkansas, United States, 72703
NEA Baptist Clinic Terminated
Jonesboro, Arkansas, United States, 72401
Clinical Trials Inc. Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
The Research Center of Southern California, LLC Terminated
Carlsbad, California, United States, 92011
ATP Clinical Research, Inc Terminated
Costa Mesa, California, United States, 92626
Neuro-Pain Medical Center Withdrawn
Fresno, California, United States, 93710
Senior Clinical Trials Terminated
Laguna Hills, California, United States, 92653
Uci Medical Center Terminated
Orange, California, United States, 92868
Neuro-Therapeutics Inc. Active, not recruiting
Pasadena, California, United States, 91105
Desert Valley Medical Group Active, not recruiting
Rancho Mirage, California, United States, 92270
Anderson Clinical Research, Inc. Active, not recruiting
Redlands, California, United States, 92374
University of California, Davis; Alzheimers Disease Center, Department of Neurology Active, not recruiting
Sacramento, California, United States, 95817
Sharp Mesa Vista Hospital Terminated
San Diego, California, United States, 92123
UCSF - Memory and Aging Center Active, not recruiting
San Francisco, California, United States, 94158
United States, Colorado
IMMUNOe Research Centers Terminated
Centennial, Colorado, United States, 80112
MCB Clinical Research Centers Active, not recruiting
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Yale University School Of Medicine Terminated
New Haven, Connecticut, United States, 06510
Research Center for Clinical Studies, Inc. Active, not recruiting
Norwalk, Connecticut, United States, 06851
KI Health Partners, LLC; New England Institute for Clinical Research Active, not recruiting
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University Hospital Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
JEM Research LLC Active, not recruiting
Atlantis, Florida, United States, 33462
Bradenton Research Center Active, not recruiting
Bradenton, Florida, United States, 34205
Neuropsychiatric Research; Center of Southwest Florida Active, not recruiting
Fort Myers, Florida, United States, 33912
University of Florida Withdrawn
Gainesville, Florida, United States, 32607
Alzheimer's Research and Treatment Center Active, not recruiting
Lake Worth, Florida, United States, 33449
Mount Sinai Medical Center Terminated
Miami Beach, Florida, United States, 33140
Renstar Medical Research Active, not recruiting
Ocala, Florida, United States, 34470
Bioclinica Research Active, not recruiting
Orlando, Florida, United States, 32806
Neurology Associates Of Ormond Beach Terminated
Ormond Beach, Florida, United States, 32174
Progressive Medical Research Active, not recruiting
Port Orange, Florida, United States, 32127
Meridien Research Terminated
Saint Petersburg, Florida, United States, 33709
Suncoast Neuroscience Associates, Inc Withdrawn
Saint Petersburg, Florida, United States, 33713
United States, Georgia
Augusta University Withdrawn
Augusta, Georgia, United States, 30912
Columbus Memory Center Active, not recruiting
Columbus, Georgia, United States, 31909
United States, Hawaii
Hawaii Pacific Neuroscience Completed
Honolulu, Hawaii, United States, 96817
United States, Idaho
Advanced Clinical Research Terminated
Meridian, Idaho, United States, 83642
United States, Illinois
Southern Illinois University, School of Medicine Terminated
Springfield, Illinois, United States, 62702
United States, Kansas
Cotton O'Neil Clinical Research Center Terminated
Topeka, Kansas, United States, 66606
United States, Louisiana
Pennington Biomedical Research Center Terminated
Baton Rouge, Louisiana, United States, 70808
Lake Charles Clinical Trials, LLC Active, not recruiting
Lake Charles, Louisiana, United States, 70601
United States, Massachusetts
McLean Hospital; First Episode Clinic Terminated
Belmont, Massachusetts, United States, 02478
Alzheimers Disease Center; Neurology Active, not recruiting
Winchester, Massachusetts, United States, 01890
United States, Minnesota
Health Partners Institute for Education and Research Active, not recruiting
Saint Paul, Minnesota, United States, 55130
United States, Mississippi
Precise Research Centers Active, not recruiting
Flowood, Mississippi, United States, 39232
University of Mississippi Medical Center Completed
Jackson, Mississippi, United States, 39216
Olive Branch Family Medical Center; Family Medicine Withdrawn
Olive Branch, Mississippi, United States, 38654
United States, Nebraska
University of Nebraska Medical Center; Dept of Neurological Sciences Active, not recruiting
Omaha, Nebraska, United States, 68198-8440
United States, Nevada
Cleveland Clinic Lou Ruvo; Center for Brain Research Active, not recruiting
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Pyramid Clinical Research Withdrawn
Monroe, New Jersey, United States, 08831
The Cognitive and Research Center of New Jersey Active, not recruiting
Springfield, New Jersey, United States, 07081
Advanced Memory Research Institute of NJ Active, not recruiting
Toms River, New Jersey, United States, 08755
United States, New Mexico
The Regents of the University of New Mexico Withdrawn
Albuquerque, New Mexico, United States, 87106
United States, New York
State University of New York at Buffalo; Department of Neurology Terminated
Buffalo, New York, United States, 14203
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
University of Rochester Medical Center; Monroe Community Hospital Terminated
Rochester, New York, United States, 14627
Richmond Behavioral Associates Withdrawn
Staten Island, New York, United States, 10312
Burke Rehabilitation Hospital Active, not recruiting
White Plains, New York, United States, 10605
United States, North Carolina
Behavioral Health Research Active, not recruiting
Charlotte, North Carolina, United States, 28211
Guilford Neurologic Associates Terminated
Greensboro, North Carolina, United States, 27401
Wake Research Associates Active, not recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Ohio Clinical Research Partners, LLC Terminated
Canton, Ohio, United States, 44718
Dayton Center for Neuro Disorders Active, not recruiting
Centerville, Ohio, United States, 45459
Carl and Edyth Lindner Center at Christ Hospital Terminated
Cincinnati, Ohio, United States, 45011
University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience Active, not recruiting
Cincinnati, Ohio, United States, 45219
Ohio State University; College of Medicine Active, not recruiting
Columbus, Ohio, United States, 43210
MDH Research LLC Withdrawn
Westerville, Ohio, United States, 43081
United States, Oklahoma
Ips Research Company Terminated
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network Inc. Active, not recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Keystone Clinical Studies, LLC Terminated
Norristown, Pennsylvania, United States, 19403
Drexel Univ College of Med; Clinical Research Group Terminated
Philadelphia, Pennsylvania, United States, 19102
Thomas Jefferson University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Northeastern Pennsylvania Memory Active, not recruiting
Plains, Pennsylvania, United States, 18705
Abington Neurological Associates Active, not recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, Tennessee
Neurology Clinic PC Active, not recruiting
Cordova, Tennessee, United States, 38018
United States, Texas
Senior Adults Specialty Research Active, not recruiting
Austin, Texas, United States, 78757
Gadolin Research, LLC Active, not recruiting
Beaumont, Texas, United States, 77702
Texas Alzheimer's and Memory Disorders Active, not recruiting
Dallas, Texas, United States, 75214
Texas Neurology PA Active, not recruiting
Dallas, Texas, United States, 75214
InSite Clinical Research Terminated
DeSoto, Texas, United States, 75115
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
The University of Texas Health Science Center at Houston Withdrawn
Houston, Texas, United States, 77054
Clinical Trials of Texas, Inc Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah, Center for Alzheimer's Care Imaging & Research Withdrawn
Salt Lake City, Utah, United States, 84108
United States, Virginia
Sentara Medical Group Active, not recruiting
Norfolk, Virginia, United States, 23507
National Clinical Research Inc.-Richmond Active, not recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Frontier Institute Terminated
Spokane, Washington, United States, 99204
United States, West Virginia
Marshall Health Withdrawn
Huntington, West Virginia, United States, 25701
Argentina
Hospital Italiano Recruiting
Buenos Aires, Argentina, C1181ACH
Universidad Maimonides Active, not recruiting
Caba, Argentina, C1405BCK
Hospital Sirio Libanes Terminated
Caba, Argentina, C1419AHN
Instituto Geriatrico Nuestra Señora de las Nieves Withdrawn
Capital Federal, Argentina, C1427
DAMIC Completed
Cordoba, Argentina, X500 3DCE
Australia, New South Wales
St Vincent's Hospital Sydney Active, not recruiting
Darlinghurst, New South Wales, Australia, 2010
Central Coast Neurosciences Research Active, not recruiting
Erina, New South Wales, Australia, 2250
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care Active, not recruiting
Hornsby, New South Wales, Australia, 2077
Australia, South Australia
The Queen Elizabeth Hospital; Neurology Active, not recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research Terminated
Fitzroy, Victoria, Australia, 3065
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre Terminated
Heidelberg West, Victoria, Australia, 3081
Royal Melbourne Hospital; Department of Neurology Completed
Parkville, Victoria, Australia, 3050
Belgium
AZ Sint Jan Active, not recruiting
Brugge, Belgium, 8000
AZ Groeninge Active, not recruiting
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg Active, not recruiting
Leuven, Belgium, 3000
Brazil
CCBR - Brasilia Active, not recruiting
Brasilia, DF, Brazil, 70200-730
Hospital das Clinicas - UFMG Active, not recruiting
Belo Horizonte, MG, Brazil, 31270-901
Instituto de Neurologia de Curitiba Active, not recruiting
Curitiba, PR, Brazil, 81210-310
Centro Psiquiatria Sandra Ruschel Ltda Active, not recruiting
Rio de Janeiro, RJ, Brazil, 22270-060
Hospital das Clinicas - UFRGS Active, not recruiting
Porto Alegre, RS, Brazil, 90035-003
Hospital Mae de Deus Withdrawn
Porto Alegre, RS, Brazil, 90470-340
Universidade Federal de Sao Paulo - UNIFESP; Neurologia Withdrawn
Sao Paulo, SP, Brazil, 04024-002
Clínica Dr. Norton Sayeg LTDA - EPP Active, not recruiting
Sao Paulo, SP, Brazil, 04063-001
Hospital das Clinicas - FMUSP; Neurologia Withdrawn
Sao Paulo, SP, Brazil, 05403-000
Canada, Alberta
University of Calgary Withdrawn
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Okanagan Clinical Trials Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 2H4
Vancouver Island Health Authority Active, not recruiting
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
True North Clinical Research-Halifax Active, not recruiting
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Kentville Active, not recruiting
Kentville, Nova Scotia, Canada, B4N 5E3
Canada, Ontario
Jbn Medical Diagnostic Services Inc. Terminated
Burlington, Ontario, Canada, L7M 4Y1
Providence Care; Mental Health Services Active, not recruiting
Kingston, Ontario, Canada, K7L 4X3
Parkwood Hospital; Geriatric Medicine Active, not recruiting
London, Ontario, Canada, N6C 5J1
Kawartha Centre - Redefining Healthy Aging Active, not recruiting
Peterborough, Ontario, Canada, K9H 2P4
The Centre for Memory and Aging Active, not recruiting
Toronto, Ontario, Canada, M4G 3E8
St. Michael's Hospital Active, not recruiting
Toronto, Ontario, Canada, M5B 1N9
Devonshire Clinical Research Inc. Active, not recruiting
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
Clinique NeuroOutaouais Terminated
Gatineau, Quebec, Canada, J8Y 1W2
Clinique Neuro Rive-Sud Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Institute Universitaire de Geriatrie de Montreal Withdrawn
Montréal, Quebec, Canada, H3W 1W5
Institut Universitaire de gériatrie de Sherbrooke Withdrawn
Sherbrooke, Quebec, Canada, J1J 3H5
Canada
ALPHA Recherche Clinique Active, not recruiting
Quebec, Canada, G3K 2P8
China
Peking University Sixth Hospital; Department of Psychiatry Recruiting
Beijing, China, 100083
Beijing Union Hospital Recruiting
Beijing, China, 100730
Beijing Tian Tan Hospital,Capital Medical University Not yet recruiting
Beijing, China
The First Affiliated Hospital, Chongqing Medical University Not yet recruiting
Chongqing, China, 400016
The second Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine Withdrawn
Hangzhou City, China, 310009
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China, 200025
Shanghai Mental Health Center Not yet recruiting
Shanghai, China, 200030
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
Tianjin Huanhu Hospital Not yet recruiting
Tianjin City, China, 300350
Denmark
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken Active, not recruiting
Aarhus C, Denmark, 8000
Rigshospitalet, Hukommelsesklinikken Active, not recruiting
København Ø, Denmark, 2100
Estonia
Laane-Tallinna Keskhaigla Active, not recruiting
Tallinn, Estonia, 10617
France
Hopital Pellegrin; Cmrr Aquitaine Active, not recruiting
Bordeaux, France, 33076
Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie Active, not recruiting
Colmar, France, 68000
Hopital Roger Salengro; Service de Neurologie Active, not recruiting
Lille, France, 59037
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique Active, not recruiting
Limoges, France, 87042
Hopital Broca Active, not recruiting
Paris, France, 75013
CH Pitie Salpetriere; IM2A Active, not recruiting
Paris, France, 75651
Hôpital Maison Blanche Active, not recruiting
Reims, France, 51092
CHU Rennes - Hopital Pontchaillou Active, not recruiting
Rennes cedex 09, France, 35033
CHU de Rouen Hopital; Service de Neurologie Active, not recruiting
Rouen, France, 76031
Hop Guillaume Et Rene Laennec; Cmrr St Herblain Active, not recruiting
St Herblain, France, 44800
Hopital des Charpennes Active, not recruiting
Villeurbanne, France, 69100
Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic Active, not recruiting
Berlin, Germany, 13125
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik Active, not recruiting
Frankfurt, Germany, 60528
Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie Active, not recruiting
Freiburg, Germany, 79106
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie Active, not recruiting
Homburg/Saar, Germany, 66421
AFL Arzneimittelforschung Leipzig GmbH Active, not recruiting
Leipzig, Germany, 04107
Pharmakologisches Studienzentrum Active, not recruiting
Mittweida, Germany, 09648
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie Active, not recruiting
München, Germany, 81675
Greece
Naval Hospital of Athen;Neurology Clinic Terminated
Athens, Greece, 11521
Papanikolaou General Hospital; Department of Neurology III Withdrawn
Thessaloniki, Greece, 57010
Guatemala
Clinica Humanamente Withdrawn
Ciudad de Guatemala, Guatemala, 01015
Nucare Withdrawn
Ciudad Guatemala, Guatemala, 01015
Hungary
Debreceni Egyetem Klinikai Kozpont; Pszichiatriai Klinika Withdrawn
Debrecen, Hungary, 4032
Pest Megyei Flor Ferenc Korhaz Withdrawn
Kistarcsa, Hungary, 2084
Pécsi Tudományegyetem Withdrawn
Pécs, Hungary, 7623
Israel
Rambam Medical Center Active, not recruiting
Haifa, Israel, 31096
Sheba Medical Center; Psychiatry Department Active, not recruiting
Ramat Gan, Israel, 5262100
Tel Aviv Sourasky Medical Center; Department of Neurology Active, not recruiting
Tel Aviv, Israel, 6423906
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia Active, not recruiting
Roma, Lazio, Italy, 00133
Policlinico Universitario Agostino Gemelli; UOC Neurologia Completed
Roma, Lazio, Italy, 00168
Umberto I Policlinico di Roma-Università di Roma La Sapienza Active, not recruiting
Roma, Lazio, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia Active, not recruiting
Roma, Lazio, Italy, 00186
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer Active, not recruiting
Brescia, Lombardia, Italy, 25125
Irccs Multimedica Santa Maria; Unita' Di Neurologia Active, not recruiting
Castellanza, Lombardia, Italy, 21053
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria Active, not recruiting
Milano, Lombardia, Italy, 20132
Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia Active, not recruiting
Milano, Lombardia, Italy, 20133
Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa Active, not recruiting
Milano, Lombardia, Italy, 20148
Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer Active, not recruiting
Passirana, Lombardia, Italy, 20017
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
A.O. Universitaria Pisana; Neurologia Active, not recruiting
Pisa, Toscana, Italy, 56126
Japan
National Center for Geriatrics and Gerontology Recruiting
Aichi, Japan, 474-8511
Hirosaki University Hospital Active, not recruiting
Aomori, Japan, 036-8563
Inage Neurology and Memory Clinic Active, not recruiting
Chiba, Japan, 263-0043
Fukuoka Mirai Hospital Active, not recruiting
Fukuoka, Japan, 813-0017
National Hospital Organization Hiroshima-Nishi Medical Center Active, not recruiting
Hiroshima, Japan, 739-0696
Sapporo Medical University Hospital Terminated
Hokkaido, Japan, 060-8543
Tsukazaki Hospital Active, not recruiting
Hyogo, Japan, 671-1227
Iwate Medical University Hospital Active, not recruiting
Iwate, Japan, 020-8505
Kagawa Prefectural Central Hospital Active, not recruiting
Kagawa, Japan, 760-8557
Yokohama General Hospital Withdrawn
Kanagawa, Japan, 225-0025
Fujisawa City Hospital Active, not recruiting
Kanagawa, Japan, 251-8550
National Hospital Organization Sagamihara National Hospital Active, not recruiting
Kanagawa, Japan, 252-0392
Koseikai Takeda Hospital Terminated
Kyoto, Japan, 600-8558
Ijinkai Takeda General Hospital Active, not recruiting
Kyoto, Japan, 601-1495
Rakuwakai Otowarehabilitation Hospital Active, not recruiting
Kyoto, Japan, 607-8113
National Hospital Organization Matsumoto Medical Center Active, not recruiting
Nagano, Japan, 399-8701
Saigata Medical Center Terminated
Niigata, Japan, 949-3193
Katayama Medical Clinic Active, not recruiting
Okayama, Japan, 710-0813
AMC Nishi Umeda Clinic Terminated
Osaka, Japan, 530-0001
Osaka Red Cross Hospital Terminated
Osaka, Japan, 543-8555
Osaka General Medical Center Terminated
Osaka, Japan, 558-8558
Osaka University Hospital Active, not recruiting
Osaka, Japan, 565-0871
Asakayama General Hospital Active, not recruiting
Osaka, Japan, 590-0018
NHO Shizuoka Institute of Epilepsy and Neurological Disorders Active, not recruiting
Shizuoka, Japan, 420-8688
Showa University East Hospital Completed
Tokyo, Japan, 142-0054
Ebara Hospital Active, not recruiting
Tokyo, Japan, 145-0065
Kanto Central Hospital Active, not recruiting
Tokyo, Japan, 158-8531
Tokyo Medical University Hospital Active, not recruiting
Tokyo, Japan, 160-0023
Shinjuku Research Park Clinic Active, not recruiting
Tokyo, Japan, 169-0073
Tokyo Metropolitan Geriatric Hospital Active, not recruiting
Tokyo, Japan, 173-0015
National Center of Neurology and Psychiatry Active, not recruiting
Tokyo, Japan, 187-8551
Tokyo Medical University Hachioji Medical Center Active, not recruiting
Tokyo, Japan, 193-0998
Tottori University Hospital Terminated
Tottori, Japan, 683-8504
Korea, Republic of
Dong-A University Hospital Active, not recruiting
Busan, Korea, Republic of, 49201
Seoul National University Bundang Hospital Active, not recruiting
Gyeonggi-do, Korea, Republic of, 13620
Gachon University Gil Medical Center Active, not recruiting
Incheon, Korea, Republic of, 21565
Seoul National University Hospital Active, not recruiting
Seoul, Korea, Republic of, 03080
Hanyang University Seoul Hospital Active, not recruiting
Seoul, Korea, Republic of, 04763
Konkuk University Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05030
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05505
Seoul St Mary's Hospital Active, not recruiting
Seoul, Korea, Republic of, 06591
Borame Medical Center Active, not recruiting
Seoul, Korea, Republic of, 07061
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of, 6351
Mexico
Investigacion Biomedica Elemental. Sapi de Cv Terminated
Guadalajara, Jalisco, Mexico, 44890
Hospital General de México Terminated
Mexico City, Mexico CITY (federal District), Mexico, 06726
Estimulacion Magnetica Trnscraneal de Mexico SC. Terminated
Mexico City, Mexico, 11000
Centro de Estudios Clinicos y Especialidades Médicas, S.C. Terminated
Monterrey, Mexico, 64620
Centro De Atencion E Investigacion Cardiovascular Del Potosi S.C. Terminated
San Luis Potosí, Mexico, 78200
Norway
Akershus universitetssykehus HF; Nevroklinikken S203 Active, not recruiting
Lørenskog, Norway, 1478
Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken Active, not recruiting
Oslo, Norway, 0450
Peru
Clinica Internacional; Unidad De Investigacion Active, not recruiting
Lima, Peru, 15001
Clinica Anglo Americana; Centro de Investigacion Neurologia II CAA Terminated
Lima, Peru, Lima 27
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia Active, not recruiting
Lima, Peru
Poland
NZOZ Dom Sue Ryder Active, not recruiting
Bydgoszcz, Poland, 85-796
UCK im. prof. K. Gibinskiego SUM; Klinika Neurologii Withdrawn
Katowice, Poland, 40-752
Centrum Medyczne Euromedis Sp. z o.o. Active, not recruiting
Szczecin, Poland, 70-111
Centrum Medyczne NeuroProtect Active, not recruiting
Warszawa, Poland, 01-684
NZOZ WCA Active, not recruiting
Wrocław, Poland, 53-139
Portugal
Hospital de Braga; Servico de Neurologia Active, not recruiting
Braga, Portugal, 4710-243
HUC; Servico de Neurologia Active, not recruiting
Coimbra, Portugal, 3000-075
Hospital Pedro Hispano; Servico de Neurologia Active, not recruiting
Matosinhos, Portugal, 4464-513
Hospital Geral de Santo Antonio; Servico de Neurologia Active, not recruiting
Porto, Portugal, 4099-001
Russian Federation
LLC Baltic Medicine Active, not recruiting
Saint-Petersburg, Sankt Petersburg, Russian Federation, 194356
State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita Active, not recruiting
Yekaterinburg, Sverdlovsk, Russian Federation, 620030
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 Active, not recruiting
Kazan, Russian Federation, 420101
Institution of RAMS (Mental Health Research Center of RAMS) Active, not recruiting
Moscow, Russian Federation, 115522
City Clinical Psychiatry Hospital #1 Active, not recruiting
Nizhny Novgorod, Russian Federation, 603155
St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy Active, not recruiting
St Petersburg, Russian Federation, 190121
Nebbiolo Center for Clinical Trials Active, not recruiting
Tomsk, Russian Federation, 634009
Serbia
Clinic for Mental disorders Dr Laza Lazarevic Active, not recruiting
Belgrade, Serbia, 11000
Neurology clinic, Clinical Center of Serbia Active, not recruiting
Belgrade, Serbia, 11000
Clinic for neurology, Clinical Center Kragujevac Active, not recruiting
Kragujevac, Serbia, 34000
South Africa
Flexivest Fourteen Research Centre Terminated
Cape Town, South Africa, 7550
Dr CC Coetzee Inc Withdrawn
Durban, South Africa, 4319
Private Practice; the Osteoporosis Clinic Active, not recruiting
Johannesburg, South Africa, 2196
Spain
Hospital General Universitario de Elche; Servicio de Neurología Active, not recruiting
Elche, Alicante, Spain, 03203
Fundació ACE Active, not recruiting
BArcelon, Barcelona, Spain, 08034
Hospital General De Catalunya; Servicio de Neurologia Active, not recruiting
Sant Cugat del Valles, Barcelona, Spain, 8195
Hospital Mutua De Terrasa; Servicio de Neurologia Active, not recruiting
Terrassa, Barcelona, Spain, 08222
Hospital Virgen del Puerto. Servicio de Neurología Active, not recruiting
Plasencia, Caceres, Spain, 10600
Hospital Universitario Marques de Valdecilla; Servicio de Neurología Active, not recruiting
Santander, Cantabria, Spain
Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies Active, not recruiting
Salt, Girona, Spain, 17090
Policlínica Guipuzkoa; Servicio de Neurología Active, not recruiting
Donosti-San Sebastián, Guipuzcoa, Spain, 20014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia Active, not recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital San Pedro; Servicio de Neurología Active, not recruiting
Logroño, LA Rioja, Spain, 26006
Hospital Universitario de Getafe; Servicio de Geriatria Active, not recruiting
Getafe, Madrid, Spain, 28905
Hospital Quiron de Madrid; Servicio de Neurologia Active, not recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Clinica Universitaria de Navarra; Servicio de Neurología Active, not recruiting
Pamplona, Navarra, Spain, 31008
CAE Oroitu Active, not recruiting
BaraKaldo, Vizcaya, Spain, 48903
Hospital Perpetuo Socorro, Servicio de Geriatria Active, not recruiting
Albacete, Spain, 2006
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia Active, not recruiting
Barcelona, Spain, 08025
Hospital Clinic i Provincial; Servicio de Neurologia Active, not recruiting
Barcelona, Spain, 08036
Hospital Universitario de Burgos. Servicio de Neurología Active, not recruiting
Burgos, Spain, 09006
Hospital la Magdalena; Servicio de Neurologia Active, not recruiting
Castellon, Spain, 12004
Hospital Universitario Reina Sofia; Servicio de Neurologia Active, not recruiting
Cordoba, Spain, 14011
Hospital Ramon y Cajal; Servicio de Neurologia Active, not recruiting
Madrid, Spain, 28034
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla Active, not recruiting
Salamanca, Spain, 37003
Hospital Universitario Virgen Macarena; Servicio de Neurologia Active, not recruiting
Sevilla, Spain, 41009
Hospital Clínico Universitario de Valladolid; Servicio de Neurología Terminated
Valladolid, Spain, 47010
Sweden
Skånes Universitetssjukhus Malmö, Minneskliniken Active, not recruiting
Malmoe, Sweden, SE-20502
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry Active, not recruiting
Mölndal, Sweden, 431 41
Taiwan
Changhua Christian Hospital; Neurology Active, not recruiting
Changhua County, Taiwan, 500
Kaohsiung Medical University Hospital; Neurology Active, not recruiting
Kaohsiung, Taiwan, 807
Chang Gung Memorial Foundation - Kaohsiung - Neurology Terminated
Kaohsiung, Taiwan, 83301
Taipei Medical University - Shuang Ho Hospital - Neurology Active, not recruiting
New Taipei City, Taiwan, 23561
National Taiwan University Hospital; Neurology Active, not recruiting
Taipei, Taiwan, 100
Chang Gung Memorial Foundation - Linkou - Neurology Active, not recruiting
Taoyuan, Taiwan, 333
Turkey
Ankara University School of Medicine; Neurology Terminated
Ankara, Turkey, 06100
Hacettepe University Medical Faculty; Neurology Active, not recruiting
Ankara, Turkey, 06100
Akdeniz University School of Medicine, Neurology Department Completed
Antalya, Turkey, 07058
Istanbul University Istanbul School of Medicine; Neurology Active, not recruiting
Istanbul, Turkey, 34093
Kocaeli University Hospital; Department of Neurology Active, not recruiting
Kocaeli, Turkey, 41380
Ondokuz Mayis Univ. Med. Fac.; Neurology Active, not recruiting
Samsun, Turkey, 55139
United Kingdom
The Rice Centre; Royal United Hospital Terminated
Bath, United Kingdom, BA1 3NG
Belfast City Hospital Withdrawn
Belfast, United Kingdom, BT9 7AB
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre Active, not recruiting
Cheltenham, United Kingdom, GL53 9DZ
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit Active, not recruiting
Chertsey, United Kingdom, KT16 0AE
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit Active, not recruiting
Crowborough, United Kingdom, TN6 1HB
Ninewells Hospital Active, not 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 Active, not recruiting
Glasgow, United Kingdom, G51 4TF
Crosshouse Hospital; NHS Ayrshire & Arran Terminated
Kilmarnock, United Kingdom, KA2 0BE
Royal Liverpool and Broadgreen University Hospital Trust Terminated
L7 8xp, United Kingdom
West London Mental Health Trust; Lakeside Mental Health Unit Withdrawn
London, United Kingdom, TW7 6FY
RE:Cognition Health Active, not recruiting
London, United Kingdom, W1G 9RU
Charing Cross Hospital; Imperial Memory Unit, Level 10 West Active, not recruiting
London, United Kingdom, W6 8RF
Manchester Royal Infirmary Active, not recruiting
Manchester, United Kingdom, M13 9WL
John Radcliffe Hospital Active, not recruiting
Oxford, United Kingdom, OX3 9DU
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust Terminated
Sheffield, United Kingdom, S10 2JF
University Southampton NHS Foundation Trust; Wessex Neurologica Centre Active, not recruiting
Southampton, United Kingdom, SO166YD
University Hospital North Midlands Terminated
Stoke on Trent, United Kingdom, ST4 6QG
Re:Cognition Health Guildford Terminated
Surrey, United Kingdom, GU2 7YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

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, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders