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Trial record 2 of 4 for:    crenezumab texas

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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03114657
First received: March 28, 2017
Last updated: August 25, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Alzheimer's Disease Drug: Crenezumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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:
  • Change from Baseline to Week 105 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Subscale Score [ Time Frame: Baseline, Week 105 ]
  • Time to Clinically Evident Decline [ Time Frame: Baseline up to Week 105 ]
    Clinically evident decline is defined by fulfilment of both of the following criteria: (1) a confirmed decline of greater than or equal to (>=) 2 points on the Mini Mental State Examination (MMSE) scale score; and (2) loss of >=1 point(s) on one or more basic Activity of Daily Living (ADL) subscale(s) score, or loss of >=2 points on one or more Instrumental Activity of Daily Living (iADL) scores. Time to clinically evident decline will be reported.

  • Change from Baseline to Week 105 in Clinical Dementia Rating-Global Score (CDR-GS) [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in MMSE Scale Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in Alzheimer's Disease Assessment Scale-Cognition 12 (ADAS-Cog-12) Subscale Score [ Time Frame: Baseline, Week 105 ]
  • Time to an Increase of >=4 Points from Baseline at any Time Before or on Week 105 in the ADAS-Cog-13 Subscale Score [ Time Frame: Baseline up to Week 105 ]
  • Change from Baseline to Week 105 in Alzheimer's Disease Cooperative Study−Activities of Daily Living Inventory Instrumental Subscale (ADCS-iADL) Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in Alzheimer's Disease Cooperative Study−Activities of Daily Living Inventory (ADCS-ADL) Total Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in Dependence Level Assessed from the ADCS-ADL Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in Functional Activities Questionnaire (FAQ) Total Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in the Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in the Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores [ Time Frame: Baseline, Week 105 ]
  • Percentage of Participants with Adverse Event (AEs) and Serious Adverse Event (SAEs) [ Time Frame: Baseline up to Week 105 ]
  • Percentage of Participants with Anti-Crenezumab Antibodies [ Time Frame: Baseline up to Week 105 ]
  • 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) ]
  • Plasma Amyloid Beta (Abeta) Concentrations [ Time Frame: Screening (Weeks -8 to -1) ; Day 1 Week 1; Weeks 5, 25, 53, and 100 ]
  • Change from Baseline to Week 105 in Brain Volume as Determined by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 105 ]

Estimated Enrollment: 750
Actual Study Start Date: March 29, 2017
Estimated Study Completion Date: October 28, 2022
Estimated Primary Completion Date: October 28, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
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
  • 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 the People's Republic of China

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
  • 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 (%)
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

  Hide Study Locations
Locations
United States, Arizona
Four Peaks Neurology Not yet recruiting
Scottsdale, Arizona, United States, 85258
Radiant Research, Inc. Recruiting
Tempe, Arizona, United States, 85282
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724-5030
United States, Arkansas
Health Initiatives Research, PLLC Recruiting
Fayetteville, Arkansas, United States, 72703
NEA Baptist Clinic Not yet recruiting
Jonesboro, Arkansas, United States, 72401
Clinical Trials Inc. Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
The Research Center of Southern California, LLC Recruiting
Carlsbad, California, United States, 92011
ATP Clinical Research, Inc Recruiting
Costa Mesa, California, United States, 92626
Senior Clinical Trials Recruiting
Laguna Hills, California, United States, 92653
Uci Medical Center Not yet recruiting
Orange, California, United States, 92868
Neuro-Therapeutics Inc. Not yet recruiting
Pasadena, California, United States, 91105
Desert Valley Medical Group Active, not recruiting
Rancho Mirage, California, United States, 92270
Anderson Clinical Research, Inc. Recruiting
Redlands, California, United States, 92374
Sharp Mesa Vista Hospital Not yet recruiting
San Diego, California, United States, 92123
United States, Colorado
1st Allergy and Clinical Research Center Not yet recruiting
Centennial, Colorado, United States, 80112
MCB Clinical Research Centers Recruiting
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
KI Health Partners, LLC; New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University Hospital Not yet recruiting
Washington, D.C., District of Columbia, United States, 20057
United States, Florida
JEM Research LLC Active, not recruiting
Atlantis, Florida, United States, 33462
Bradenton Research Center Not yet recruiting
Bradenton, Florida, United States, 34205
Neuropsychiatric Research; Center of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33912
University of Florida Withdrawn
Gainesville, Florida, United States, 32607
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Mount Sinai Medical Center Not yet recruiting
Miami Beach, Florida, United States, 33140
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34471
Neurology Associates Of Ormond Beach Not yet recruiting
Ormond Beach, Florida, United States, 32174
Meridien Research Not yet recruiting
Saint Petersburg, Florida, United States, 33709
Suncoast Neuroscience Associates, Inc Not yet recruiting
Saint Petersburg, Florida, United States, 33713
United States, Georgia
Augusta University Not yet recruiting
Augusta, Georgia, United States, 30912
Columbus Memory Center Not yet recruiting
Columbus, Georgia, United States, 31909
United States, Hawaii
Hawaii Pacific Neuroscience Not yet recruiting
Honolulu, Hawaii, United States, 96817
United States, Idaho
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
Southern Illinois University, School of Medicine Not yet recruiting
Springfield, Illinois, United States, 62702
United States, Kansas
Cotton O'Neil Clinical Research Center Recruiting
Topeka, Kansas, United States, 66606
United States, Louisiana
Pennington Biomedical Research Center Not yet recruiting
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 Not yet recruiting
Belmont, Massachusetts, United States, 02478
Alzheimers Disease Center; Neurology Not yet recruiting
Winchester, Massachusetts, United States, 01890
United States, Minnesota
Health Partners Institute for Education and Research Not yet recruiting
Saint Paul, Minnesota, United States, 55130
United States, Mississippi
University of Mississippi Medical Center Not yet recruiting
Jackson, Mississippi, United States, 39216
Olive Branch Family Medical Center; Family Medicine Not yet recruiting
Olive Branch, Mississippi, United States, 38654
United States, Nebraska
University of Nebraska Medical Center; Dept of Neurological Sciences Not yet recruiting
Omaha, Nebraska, United States, 68198-8440
United States, New Jersey
Pyramid Clinical Research Not yet recruiting
Monroe, New Jersey, United States, 08831
Advanced Memory Research Institute of NJ Not yet recruiting
Toms River, New Jersey, United States, 08755
United States, New Mexico
The Regents of the University of New Mexico Not yet recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
State University of New York at Buffalo; Department of Neurology Not yet recruiting
Buffalo, New York, United States, 14203
University of Rochester Medical Center; Monroe Community Hospital Not yet recruiting
Rochester, New York, United States, 14627
Richmond Behavioral Associates Not yet recruiting
Staten Island, New York, United States, 10312
Burke Medical Research Institutes Not yet recruiting
White Plains, New York, United States, 10605
United States, North Carolina
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Ohio Clinical Research Partners, LLC Not yet recruiting
Canton, Ohio, United States, 44718
Dayton Center for Neuro Disorders Not yet recruiting
Centerville, Ohio, United States, 45459
Carl and Edyth Lindner Center at Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45011
University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience Not yet recruiting
Cincinnati, Ohio, United States, 45219
Ohio State University; College of Medicine Recruiting
Columbus, Ohio, United States, 43210
Neurology and Neuroscience Assoc., Inc. Not yet recruiting
Westerville, Ohio, United States, 43081
United States, Oklahoma
Ips Research Company Not yet recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Keystone Clinical Studies, LLC Not yet recruiting
Norristown, Pennsylvania, United States, 19403
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Northeastern Pennsylvania Memory Recruiting
Plains, Pennsylvania, United States, 18705
Abington Neurological Associates Recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, Tennessee
Neurology Clinic PC Recruiting
Cordova, Tennessee, United States, 38018
United States, Texas
Senior Adults Specialty Research Recruiting
Austin, Texas, United States, 78757
Gadolin Research, LLC Recruiting
Beaumont, Texas, United States, 77701
Texas Neurology PA Recruiting
Dallas, Texas, United States, 75214
InSite Clinical Research Recruiting
DeSoto, Texas, United States, 75115
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
McGovern Medical School of UT Health Houston Not yet recruiting
Houston, Texas, United States, 77054
Clinical Trials of Texas, Inc Not yet recruiting
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah, Center for Alzheimer's Care Imaging & Research Not yet recruiting
Salt Lake City, Utah, United States, 84108
United States, Virginia
Sentara Medical Group Not yet recruiting
Norfolk, Virginia, United States, 23510
National Clinical Research Inc.-Richmond Not yet recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Frontier Institute Recruiting
Spokane, Washington, United States, 99204
United States, West Virginia
Marshall Health Not yet recruiting
Huntington, West Virginia, United States, 25701
Argentina
Hospital Italiano Not yet recruiting
Buenos Aires, Argentina, C1181ACH
CEMIC Not yet recruiting
Buenos Aires, Argentina, C1431FWO
Universidad Maimonides Not yet recruiting
Caba, Argentina, C1405BCK
Hospital Sirio Libanes Not yet recruiting
Caba, Argentina, C1419AHN
DAMIC Not yet recruiting
Córdoba, Argentina
Australia, New South Wales
St Vincent's Hospital Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Central Coast Neurosciences Research Recruiting
Erina, New South Wales, Australia, 2250
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care Not yet recruiting
Hornsby, New South Wales, Australia, 2077
Australia, South Australia
The Queen Elizabeth Hospital; Neurology Not yet recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre Not yet recruiting
Heidelberg West, Victoria, Australia, 3081
Royal Melbourne Hospital; Department of Neurology Not yet recruiting
Parkville, Victoria, Australia, 3050
Belgium
AZ Sint Jan Not yet recruiting
Brugge, Belgium, 8000
AZ Groeninge (Kennedylaan) Recruiting
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
Brazil
CCBR - Brasilia Not yet recruiting
Brasilia, DF, Brazil, 70200-730
Hospital das Clinicas - UFMG Not yet recruiting
Belo Horizonte, MG, Brazil, 31270-901
Instituto de Neurologia de Curitiba Not yet recruiting
Curitiba, PR, Brazil, 81210-310
Centro Psiquiatria Sandra Ruschel Ltda Not yet recruiting
Rio de Janeiro, RJ, Brazil, 22270-060
Hospital das Clinicas - UFRGS Not yet 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 Not yet recruiting
Sao Paulo, SP, Brazil, 04063-001
Hospital das Clinicas - FMUSP; Neurologia Not yet recruiting
Sao Paulo, SP, Brazil, 05403-000
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Okanagan Clinical Trials Recruiting
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Nova Scotia
True North Clinical Research-Halifax Not yet recruiting
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Kentville Not yet recruiting
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Jbn Medical Diagnostic Services Inc. Not yet recruiting
Burlington, Ontario, Canada, L7M 4Y1
Providence Care; Mental Health Services Not yet recruiting
Kingston, Ontario, Canada, K7L 4X3
Kawartha Regional Memory Clinic Not yet recruiting
Peterborough, Ontario, Canada, K9H 2P4
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1N9
Canada, Quebec
Clinique NeuroOutaouais Recruiting
Gatineau, Quebec, Canada, J9J 0A5
Clinique Neuro Rive-Sud Recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Institute Universitaire de Geriatrie de Montreal Not yet recruiting
Montréal, Quebec, Canada, H3W 1W5
Institut Universitaire de gériatrie de Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada, J1J 3H5
Canada
ALPHA Recherche Clinique Recruiting
Quebec, Canada, G3K 2P8
France
Hopital Pellegrin; Cmrr Aquitaine Not yet recruiting
Bordeaux, France, 33076
Hôpital de Jour du Centre pour Personnes Âgées ; Louis Pasteur Neurologie Not yet recruiting
Colmar, France, 68000
Hopital Roger Salengro; Service de Neurologie Not yet recruiting
Lille, France, 59037
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique Not yet recruiting
Limoges, France, 87042
Hopital Broca Not yet recruiting
Paris, France, 75013
CH Pitie Salpetriere; IM2A Not yet recruiting
Paris, France, 75651
Hôpital Maison Blanche Not yet recruiting
Reims, France, 51092
CHU Rennes - Hopital Pontchaillou Not yet recruiting
Rennes cedex 09, France, 35033
CHU de Rouen Hopital; Service de Neurologie Not yet recruiting
Rouen, France, 76031
Hop Guillaume Et Rene Laennec; Cmrr St Herblain Not yet recruiting
St Herblain, France, 44800
Hopital des Charpennes Not yet recruiting
Villeurbanne, France, 69100
Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic Not yet recruiting
Berlin, Germany, 13125
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik Not yet recruiting
Frankfurt, Germany, 60528
Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie Not yet recruiting
Freiburg, Germany, 79106
Universitaetsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie Not yet recruiting
Homburg/Saar, Germany, 66421
AFL Arzneimittelforschung Leipzig GmbH Not yet recruiting
Leipzig, Germany, 04107
Pharmakologisches Studienzentrum Not yet recruiting
Mittweida, Germany, 09648
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie Not yet recruiting
München, Germany, 81675
Greece
Naval Hospital of Athen;Neurology Clinic Not yet recruiting
Athens, Greece, 11521
Papanikolaou General Hospital; Department of Neurology III Not yet recruiting
Thessaloniki, Greece, 57010
Guatemala
Clinica Humanamente Not yet recruiting
Ciudad de Guatemala, Guatemala, 01015
Nucare Not yet recruiting
Ciudad Guatemala, Guatemala, 01015
Hungary
Debreceni Egyetem Klinikai Kozpont; Pszichiatriai Klinika Not yet recruiting
Debrecen, Hungary, 4032
Pest Megyei Flor Ferenc Korhaz Not yet recruiting
Kistarcsa, Hungary, 2084
Pécsi Tudományegyetem Not yet recruiting
Pécs, Hungary, 7623
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel, 31096
Sheba Medical Center; Psychiatry Department Recruiting
Ramat Gan, Israel, 5262100
Tel Aviv Sourasky Medical Center; Department of Neurology Not yet recruiting
Tel Aviv, Israel, 6423906
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia Not yet recruiting
Roma, Lazio, Italy, 00133
Policlinico Universitario Agostino Gemelli; UOC Neurologia Not yet recruiting
Roma, Lazio, Italy, 00168
Umberto I Policlinico di Roma-Università di Roma La Sapienza Not yet recruiting
Roma, Lazio, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia Not yet recruiting
Roma, Lazio, Italy, 00186
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer Not yet recruiting
Brescia, Lombardia, Italy, 25125
Irccs Multimedica Santa Maria; Unita' Di Neurologia Not yet recruiting
Castellanza, Lombardia, Italy, 21053
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria Recruiting
Milano, Lombardia, Italy, 20132
Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia Recruiting
Milano, Lombardia, Italy, 20133
Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer Not yet recruiting
Passirana, Lombardia, Italy, 20017
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA Recruiting
Pozzilli, Molise, Italy, 86077
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria Not yet recruiting
Torino, Piemonte, Italy, 10126
A.O. Universitaria Pisana; Neurologia Not yet recruiting
Pisa, Toscana, Italy, 56126
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Seoul National University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 13620
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Hanyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of, 04763
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 06351
Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Mexico
Investigacion Biomedica Elemental. Sapi de Cv Not yet recruiting
Guadalajara, Jalisco, Mexico, 44890
Hospital General de México Not yet recruiting
Mexico City, Mexico, 06726
Estimulacion Magnetica Trnscraneal de Mexico SC. Not yet recruiting
Mexico City, Mexico, 11000
Centro de Estudios Clinicos y Especialidades Médicas, S.C. Not yet recruiting
Monterrey, Mexico, 64620
Centro De Atencion E Investigacion Cardiovascular Del Potosi S.C. Not yet recruiting
San Luis Potosí, Mexico, 78200
Norway
Akershus universitetssykehus HF; Nevroklinikken S203 Recruiting
Lørenskog, Norway, 1478
Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken Not yet recruiting
Oslo, Norway, 0450
Peru
Clinica Internacional; Unidad De Investigacion Not yet recruiting
Lima, Peru, 15001
Clinica Anglo Americana; Centro de Investigacion Neurologia II CAA Not yet recruiting
Lima, Peru, Lima 27
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia Not yet recruiting
Lima, Peru
Poland
NZOZ Dom Sue Ryder Not yet recruiting
Bydgoszcz, Poland, 85-796
UCK im. prof. K. Gibinskiego SUM; Klinika Neurologii Not yet recruiting
Katowice, Poland, 40-752
Centrum Medyczne Euromedis Sp. z o.o. Recruiting
Szczecin, Poland
Laane-Tallinna Keskhaigla Recruiting
Tallinn, Poland, 10617
NZOZ WCA Not yet recruiting
Wrocław, Poland, 53-139
Portugal
Hospital de Braga; Servico de Neurologia Recruiting
Braga, Portugal, 4710-243
HUC; Servico de Neurologia Not yet recruiting
Coimbra, Portugal, 3000-075
Hospital Pedro Hispano; Servico de Neurologia Not yet recruiting
Matosinhos, Portugal, 4464-513
Hospital Geral de Santo Antonio; Servico de Neurologia Not yet recruiting
Porto, Portugal, 4099-001
Russian Federation
LLC Baltic Medicine Recruiting
Saint-Petersburg, Sankt Petersburg, Russian Federation, 194356
State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita Recruiting
Yekaterinburg, Sverdlovsk, Russian Federation, 620030
Republican clinical hospital of regenerative treatment of Ministry of Health of Tatarstan republic Not yet recruiting
Kazan, Russian Federation, 420021
State autonomous institution of healthcare Inter-regional clinical and diagnostic center Not yet recruiting
Kazan, Russian Federation, 420101
Institution of RAMS (Mental Health Research Center of RAMS) Recruiting
Moscow, Russian Federation, 115522
City Clinical Psychiatry Hospital #1 Recruiting
Nizhny Novgorod, Russian Federation, 603155
St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy Recruiting
St Petersburg, Russian Federation, 190121
Nebbiolo Center for Clinical Trials Not yet recruiting
Tomsk, Russian Federation, 634009
Serbia
Hospital for psychiatric diseases"Dr Laza Lazarevic" Not yet recruiting
Belgrade, Serbia
Institute of Neurology Not yet recruiting
Belgrade, Serbia
Clinic for neurology, Clinical Center Kragujevac Not yet recruiting
Kragujevac, Serbia, 34000
South Africa
Flexivest Fourteen Research Centre Recruiting
Cape Town, South Africa, 7550
Dr CC Coetzee Inc Withdrawn
Durban, South Africa, 4319
Private Practice; the Osteoporosis Clinic Recruiting
Johannesburg, South Africa, 2196
Spain
Hospital General Universitario de Elche; Servicio de Neurología Not yet recruiting
Elche, Alicante, Spain, 03203
Fundació ACE Not yet recruiting
BArcelon, Barcelona, Spain, 08034
Hospital General De Catalunya; Servicio de Neurologia Not yet recruiting
Sant Cugat del Valles, Barcelona, Spain, 8195
Hospital Mutua De Terrasa; Servicio de Neurologia Not yet recruiting
Terrasa, Barcelona, Spain, 08221
Hospital Virgen del Puerto. Servicio de Neurología Not yet recruiting
Plasencia, Caceres, Spain, 10600
Hospital Universitario Marques de Valdecilla; Servicio de Neurología Not yet recruiting
Santander, Cantabria, Spain
Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies Recruiting
Salt, Girona, Spain, 17090
Policlínica Guipuzkoa; Servicio de Neurología Recruiting
Donosti-San Sebastián, Guipuzcoa, Spain, 20014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia Recruiting
Santiago de Compostela, La Coruña, Spain, 15706
Hospital San Pedro; Servicio de Neurología Recruiting
Logroño, La Rioja, Spain, 26006
Hospital Universitario de Getafe; Servicio de Geriatria Not yet 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 Not yet recruiting
Pamplona, Navarra, Spain, 31008
CAE Oroitu Not yet recruiting
BaraKaldo, Vizcaya, Spain, 48903
Hospital Perpetuo Socorro, Servicio de Geriatria Not yet recruiting
Albacete, Spain, 2006
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia Recruiting
Barcelona, Spain, 08025
Hospital Clinic i Provincial; Servicio de Neurologia Recruiting
Barcelona, Spain, 08036
Hospital Universitario de Burgos. Servicio de Neurología Not yet recruiting
Burgos, Spain, 09006
Hospital la Magdalena; Servicio de Neurologia Recruiting
Castellon, Spain, 12004
Hospital Universitario Reina Sofia; Servicio de Neurologia 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 Not yet recruiting
Salamanca, Spain, 37003
Hospital Universitario Virgen Macarena; Servicio de Neurologia Recruiting
Sevilla, Spain, 41009
Hospital Clínico Universitario de Valladolid; Servicio de Neurología Not yet recruiting
Valladolid, Spain, 47010
Sweden
Skånes Universitetssjukhus Malmö, Minneskliniken Not yet recruiting
Malmoe, Sweden, SE-20502
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry Not yet recruiting
Mölndal, Sweden, 431 41
Taiwan
Changhua Christian Hospital; Neurology Not yet recruiting
Changhua County, Taiwan, 500
Kaohsiung Medical University Hospital; Neurology Not yet recruiting
Kaohsiung, Taiwan, 807
Chang Gung Memorial Foundation - Kaohsiung - Neurology Not yet recruiting
Kaohsiung, Taiwan, 83301
Taipei Medical University - Shuang Ho Hospital - Neurology Not yet recruiting
New Taipei City, Taiwan, 23561
National Taiwan University Hospital; Neurology Not yet recruiting
Taipei, Taiwan, 100
Chang Gung Memorial Foundation - Linkou - Neurology Not yet recruiting
Taoyuan, Taiwan, 333
Turkey
Ankara University School of Medicine; Neurology Recruiting
Ankara, Turkey, 06100
Akdeniz University School of Medicine, Neurology Department Recruiting
Antalya, Turkey, 07058
Kocaeli University Hospital; Department of Neurology Recruiting
Kocaeli, Turkey, 41380
United Kingdom
The Rice Centre; Royal United Hospital Recruiting
Bath, United Kingdom, BA1 3NG
Belfast City Hospital Not yet recruiting
Belfast, United Kingdom, BT9 7AB
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre Recruiting
Cheltenham, United Kingdom, GL53 9DZ
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit Not yet 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
Crosshouse Hospital; NHS Ayrshire & Arran Not yet recruiting
Kilmarnock, United Kingdom, KA2 0BE
Royal Liverpool and Broadgreen University Hospital Trust Not yet recruiting
L7 8xp, United Kingdom
West London Mental Health Trust; Lakeside Mental Health Unit Not yet recruiting
London, United Kingdom, TW7 6FY
RE:Cognition Health Recruiting
London, United Kingdom, W1G 9RU
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
University Hospital North Midlands Recruiting
Stoke on Trent, United Kingdom, ST4 6QG
Re:Cognition Health Guildford Recruiting
Surrey, United Kingdom, GU2 7YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03114657     History of Changes
Other Study ID Numbers: BN29553
2016-003288-20 ( EudraCT Number )
Study First Received: March 28, 2017
Last Updated: August 25, 2017

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

ClinicalTrials.gov processed this record on September 20, 2017