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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02670083
Recruitment Status : Active, not recruiting
First Posted : February 1, 2016
Last Update Posted : July 11, 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 final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 813 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 22, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : July 31, 2021

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 by IV infusion q4w for 100 weeks.

Placebo Comparator: Placebo
Participants will receive 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) Score [ Time Frame: Baseline, Week 105 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 105 on Cognition, as assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (subscales) 13 (ADAS-Cog-13) and 11 (ADAS-Cog-11) [ Time Frame: Baseline, Week 105 ]
  2. Change from Baseline to Week 105 on Severity of Dementia, Assessed Using the CDR-Gloal Score (CDR-GS) [ Time Frame: Baseline, Week 105 ]
  3. Change from Baseline to Week 105 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE) [ Time Frame: Baseline, Week 105 ]
  4. Change from Baseline to Week 105 on function as assessed by the ADCS-ADL total score and the ADCS-instrumental subscore [ Time Frame: Baseline, Week 105 ]
  5. Change from Baseline to Week 105 on a measure of dependence derived from the ADCS-ADL score [ Time Frame: Baseline, Week 105 ]
  6. Change from Baseline to Week 105 assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Baseline, Week 105 ]
  7. Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score [ Time Frame: Baseline up to Week 105 ]
  8. Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score [ Time Frame: Baseline up to Week 105 ]
  9. EQ-5D Questionnaire Domain Score [ Time Frame: Baseline up to Week 105 ]
  10. Percentage of Participants with Adverse Event (AEs) and Serious Adverse Event (SAEs) [ Time Frame: Up to Week 105 ]
  11. Percentage of Participants with Anti-Crenezumab Antibodies [ Time Frame: Baseline up to Week 105 ]
  12. 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) ]
  13. Plasma Amyloid Beta (Abeta) Concentrations [ Time Frame: Screening (Weeks -8 to -1) ; Day 1 Week 1; Weeks 5, 25, 53, and 100 ]
  14. Change from Baseline to Week 105 in Brain Volume as Determined by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 105 ]
  15. Cerebrospinal Fluid (CSF) Concentration of Crenezumab [ Time Frame: At pre-defined intervals from baseline through week 105 ]
  16. Brain Amyloid Load Over Time Measured by Amyloid-PET [ Time Frame: At pre-defined intervals from baseline through week 105 ]
  17. Brain Tau Load Over Time Measured by Tau-PET [ Time Frame: At pre-defined intervals from baseline through week 105 ]
  18. 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

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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:
  • 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
  • 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 PET scan by qualitative read by the core/central PET laboratory
  • Demonstrated abnormal memory function at screening
  • Screening mini mental state examination (MMSE) score of greater than or equal to (>=) 22 points and Clinical Dementia Rating-Global Score (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

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
  • History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
  • 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 (e.g., myocardial infarction)
  • Uncontrolled hypertension
  • Screening hemoglobin A1c (HbA1C) >8%
  • 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): NCT02670083


  Hide Study Locations
Locations
United States, Arizona
Xenoscience
Phoenix, Arizona, United States, 85004
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Insitute
Sun City, Arizona, United States, 85351
United States, California
American Neuropsychiatric Research Institute Inc
Carson, California, United States, 90746
Pharmacology Research Inst
Encino, California, United States, 91316
Alliance for Wellness, dba Alliance for Research
Long Beach, California, United States, 90807
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
USC Keck School Of Medicine
Los Angeles, California, United States, 90033
UCLA Medical Center, Department of Neurology
Los Angeles, California, United States, 90095
Pharmacology Research Inst
Newport Beach, California, United States, 92660
Shankle Clinic
Newport Beach, California, United States, 92663
Stanford Univ Medical Center
Palo Alto, California, United States, 94304
Anderson Clinical Research, Inc.
Redlands, California, United States, 92374
University of California, Davis; Alzheimers Disease Center, Department of Neurology
Sacramento, California, United States, 95817
UCSF - Memory and Aging Center
San Francisco, California, United States, 94158
Neurological Research Inst
Santa Monica, California, United States, 90404
North Bay Neuro Science Institute
Sebastopol, California, United States, 95472
Collaborative Neuroscience Network Inc.
Torrance, California, United States, 90502
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Associated Neurologists PC - Danbury
Danbury, Connecticut, United States, 06810
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Bradenton Research Center
Bradenton, Florida, United States, 34205
Quantum Laboratories
Deerfield Beach, Florida, United States, 33064
Brain Matters Research, Inc.
Delray Beach, Florida, United States, 33445
Cohen Medical Research Associates, LLC
Delray Beach, Florida, United States, 33446
Galiz Research, LLC
Hialeah, Florida, United States, 33016
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States, 32216
Clinical Neuroscience Solutions Inc; Jacksonville Clinic
Jacksonville, Florida, United States, 32256
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33449
Merritt - Island Medical Research
Merritt Island, Florida, United States, 32952
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Renstar Medical Research
Ocala, Florida, United States, 34470
CNS Healthcare
Orlando, Florida, United States, 32801
Bioclinica Research
Orlando, Florida, United States, 32806
Progressive Medical Research
Port Orange, Florida, United States, 32127
Miami Research Associates
South Miami, Florida, United States, 33143
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
Tampa, Florida, United States, 33613
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
Compass Research
The Villages, Florida, United States, 32162
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
NeuroStudies.net, LLC
Decatur, Georgia, United States, 30033
United States, Illinois
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States, 60007
Southern Illinois University, School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
MidAmerica Neuroscience Institute
Prairie Village, Kansas, United States, 66206
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
MMP Neurology
Scarborough, Maine, United States, 04074
United States, Massachusetts
Springfield Neurology Associates
Springfield, Massachusetts, United States, 01104
United States, Michigan
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
Kalamazoo, Michigan, United States, 49008
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States, 63141
United States, Nevada
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
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
Neurology Specialists of Monmouth County, PA
West Long Branch, New Jersey, United States, 07764
United States, New Mexico
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States, 87109
United States, New York
Albany Medical Faculty Physicians COmmunity Division. The Neurology Group
Albany, New York, United States, 12206
Neurological Associates of Albany, PC
Albany, New York, United States, 12298
Columbia University Medical Center
New York, New York, United States, 10032
South Shore Neurologic Associates P.C.
Patchogue, New York, United States, 11772
Dent Neurological Institute
Williamsville, New York, United States, 14221
United States, North Carolina
Behavioral Health Research
Charlotte, North Carolina, United States, 28211
Alzheimer's Memory Center
Charlotte, North Carolina, United States, 28270
Guilford Neurologic Associates
Greensboro, North Carolina, United States, 27401
United States, Ohio
Valley Medical Primary Care
Centerville, Ohio, United States, 45459
UC Health Neurology
Dayton, Ohio, United States, 45417
Insight Clinical Trials LLC
Shaker Heights, Ohio, United States, 44122
United States, Oklahoma
Oklahoma Clinical Research
Oklahoma City, Oklahoma, United States, 73112
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
Tulsa Clinical Research LLC
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Summit Research Network Inc.
Portland, Oregon, United States, 97210
Neural Net Research; Neural Net Research
Portland, Oregon, United States, 97225
United States, Pennsylvania
Drexel Univ College of Med; Clinical Research Group
Philadelphia, Pennsylvania, United States, 19102
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Roper Hospital Laboratory
Charleston, South Carolina, United States, 29403
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Texas Alzheimer's and Memory Disorders
Dallas, Texas, United States, 75214
University of North Texas Health Science Center; Fort Worth Patient Care Center
Fort Worth, Texas, United States, 76107
United States, Utah
Radiant Research, Inc.
Salt Lake City, Utah, United States, 84123
United States, Virginia
Sentara Medical Group
Norfolk, Virginia, United States, 23507
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States, 23294
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, Australia, 5011
Australia, Victoria
Caulfield Hospital; Aged Psychiatry Research Unit
Caulfield, Victoria, Australia, 3162
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Neurodegenerative Disorders Research; Neurology
West Perth, Western Australia, Australia, 6005
Austria
LKH Hall;Abteilung für Psychiatrie und Psychotherapie A
Hall in Tirol, Austria, 6060
Konventhospital Barmherzige Brüder; Neurologie I
Linz, Austria, 4021
Belgium
UZ Gent
Gent, Belgium, 9000
Bulgaria
UMHAT Sveti Georgi Clinic of neurology
Plovdiv, Bulgaria, 4000
MHAT National Cardiology Hospital, EAD; Neurology
Sofia, Bulgaria, 1309
Tokuda Hospital; Department of Neurology
Sofia, Bulgaria, 1407
Alexandrovska hospital; Neurology Department
Sofia, Bulgaria, 1431
Canada, British Columbia
Vancouver Hospital - UBC Hospital Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8
Canada, Ontario
Parkwood Hospital; Geriatric Medicine
London, Ontario, Canada, N6C 5J1
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada, K9H 2P4
The Centre for Memory and Aging
Toronto, Ontario, Canada, M4G 3E8
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
CHA Hopital de I enfant-Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Diex Recherche Sherbrooke
Sherbrooke, Quebec, Canada, J1H 1Z1
Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San Jose, Costa Rica, 10108
Hospital Clínica Biblica
San José, Costa Rica, 10101
Croatia
Clinical Hospital Center Sestre Milosrdnice
Zagreb, Croatia, 10000
Clinical Hospital Centre Zagreb;Clinic for Neurology
Zagreb, Croatia, 10000
Czechia
The University Hospital Brno
Brno, Czechia, 62500
Charles University, Medical faculty, Hradec Kralove ;Department of Neurology
Hradec Králové, Czechia, 500 05
General Teaching Hospital, Departmetn of Neurology
Praha, Czechia, 110 00
Denmark
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
Aarhus C, Denmark, 8000
Rigshospitalet, Hukommelsesklinikken
København Ø, Denmark, 2100
Finland
Terveystalo Tampere
Tampere, Finland, 33100
CRST Oy
Turku, Finland, 20520
France
Hopital Avicenne; Neurologie
Bobigny, France, 93009
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, France, 69677
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, France, 13005
Hopital Gui de Chauliac; Neurologie
Montpellier, France, 34295
Hopital Lariboisiere
Paris, France, 75475
CHU Poitiers - Hopital La Miletrie
Poitiers, France, 86000
Hopital Hautepierre; Centre dInvestigation Clinique
Strasbourg, France, 67098
CHU Toulouse - La Grave
Toulouse, France, 31059
Germany
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Neurologie
Berlin, Germany, 12203
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Psychiatrie & Psychotherapie
Dresden, Germany, 01307
Evang. Krankenhaus Bethanien; Fachkrankenhaus für Psychiatrie, Psychosomatik und Psychotherapie
Greifswald, Germany, 17489
Neurologische Praxis Dr. Andrej Pauls
München, Germany, 80331
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, Germany, 81675
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster, Germany, 48149
Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie
Nürnberg, Germany, 90402
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Uni. Regensburg am Bezirksklinikum
Regensburg, Germany, 93053
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
Rostock, Germany, 18147
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, Germany, 89081
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
Westerstede, Germany, 26655
Forschungszentrum Ruhr
Witten, Germany, 58455
Hong Kong
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
Hong Kong, Hong Kong
Queen Mary Hospital, Division of Geriatric Medicine
Hong Kong, Hong Kong
Tuen Mun Hospital; Medicine & Geriatrics
Tuen Mun, Hong Kong
Hungary
Dr. Kenessey Albert Korhaz-Rendelointezet; Pszichiatria I
Balassagyarmat, Hungary, 2660
Semmelweis University; Department of Neurology
Budapest, Hungary, 1083
Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria
Nyíregyháza, Hungary, 4400
University of Szeged; Department of Psychiatry
Szeged, Hungary, 6725
Szent Borbala Korhaz; Neurologiai es Stroke Osztaly
Tatabánya, Hungary, 2800
Jávorszky Ödön Kórház, Neurológia és stroke osztály
VAC, Hungary, 2600
Italy
Azienda Sanitaria Provinciale Di Catanzaro-P.O. Giovanni Paolo II; Centro Regionale Di Neurogenetica
Lamezia Terme (CZ), Calabria, Italy, 88046
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
Roma, Lazio, Italy, 00179
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Roma, Lazio, Italy, 00186
Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia
Genova, Liguria, Italy, 16128
Irccs Aou San Martino - Ist; Dipartimento Di Medicina Interna
Genova, Liguria, Italy, 16132
Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative
Milano, Lombardia, Italy, 20144
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
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria
Perugia, Umbria, Italy, 06129
Japan
National Center for Geriatrics and Gerontology
Aichi, Japan, 474-8511
Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017
Miyoshi Clinic of Neurology, Hananosato
Hiroshima, Japan, 728-0013
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, Japan, 739-0696
Sapporo Medical University Hospital
Hokkaido, Japan, 060-8543
Iwate Medical University Hospital
Iwate, Japan, 020-8505
Kagawa Prefectural Central Hospital
Kagawa, Japan, 760-8557
Fujisawa City Hospital
Kanagawa, Japan, 251-8550
Koseikai Takeda Hospital
Kyoto, Japan, 600-8558
Ijinkai Takeda General Hospital
Kyoto, Japan, 601-1495
Rakuwakai Otowarehabilitation Hospital
Kyoto, Japan, 607-8113
Mie University Hospital
Mie, Japan, 514-8507
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
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, 193-0944
Tottori University Hospital
Tottori, Japan, 683-8504
Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of, 61469
Inha University Hospital
Incheon, Korea, Republic of, 22332
Konkuk University Medical Center
Seoul, Korea, Republic of, 05030
Asan Medical Center
Seoul, Korea, Republic of, 05505
KyungHee Medical Center
Seoul, Korea, Republic of, 130-702
Ewha Womans University Mokdong Hospital; Dept of Neurology
Seoul, Korea, Republic of, 158-710
Lithuania
Kaunas Medical University Hospital; Department of Neurology
Kaunas, Lithuania, 50009
Vilnius University Hospital Santariskiu Clinic
Vilnius, Lithuania, 08661
Mexico
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Culiacan, Mexico, 80020
Hospital Uni; Dr. Jose E. Gonzalez
Monterrey, Mexico, 64460
AVIX Investigación Clínica S.C
Monterrey, Mexico, 64710
Hospital Universitario de Saltillo
Saltillo, Mexico, 25000
Poland
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna
Bialystok, Poland, 15-402
Podlaskie Centrum Psychogeriatrii
Białystok, Poland, 15-756
KOPERNICUS Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland, 80-462
Centrum Neurologii Klinicznej
Krakow, Poland, 31-505
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
Poznan, Poland, 61-289
Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa
Poznań, Poland, 60-848
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, Poland, 41-100
Przychodnia Specjalistyczna PROSEN
Warszawa, Poland, 01-231
Centrum Medyczne NeuroProtect
Warszawa, Poland, 01-684
Optimum
Warszawa, Poland, 01-785
Centralny Szpital Kliniczny MSWiA Klinika Neurologii
Warszawa, Poland, 02-507
Uniwersytet Medyczny w Lodzi Katedra Psychiatrii
Łódź, Poland, 92-216
Portugal
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Amadora, Portugal, 2720-276
Hospital Beatriz Angelo; Servico de Neurologia
Loures, Portugal, 2674-514
Russian Federation
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
SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
Moscow, Russian Federation, 119021
City Clinical Hospital # 2 n.a. V.I. Razumovsky
Saratov, Russian Federation, 410028
SHI City Psychoneurological Dispensary #7
St Petersburg, Russian Federation, 190005
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
St. Petersburg, Russian Federation, 194044
Slovenia
University Medical Centre
Ljubljana, Slovenia, 1000
University Medical Centre Maribor
Maribor, Slovenia, 2000
Spain
Fundació ACE
BArcelon, Barcelona, Spain, 08034
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Sant Joan de Deu; Servicio de Neurología
Manresa, Barcelona, Spain
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Valles, Barcelona, Spain, 8195
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrasa, Barcelona, Spain, 08221
Hospital Virgen del Puerto. Servicio de Neurología
Plasencia, Caceres, Spain, 10600
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
Santander, Cantabria, Spain
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarra, Spain, 31008
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
Salamaca, Salamanca, Spain, 37007
Hospital General Universitario de Albacete; Servicio de Neurología
Albacete, Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona, Spain, 08035
Hospital Universitario de Burgos. Servicio de Neurología
Burgos, Spain, 09006
Hospital Lucus Augusti; Servicio de Neurología
Lugo, Spain
Clinica Ruber, 4 planta; Servicio de Neurologia
Madrid, Spain, 28006
Universitario de La Princesa; Servicio de Neurología
Madrid, Spain, 28006
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, Spain, 28041
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Malaga, Spain, 29010
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
Murcia, Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, Spain, 46026
Servicio de Neurología Hospital Viamed Montecanal.
Zaragoza, Spain, 50012
Sweden
Skånes Universitetssjukhus Malmö, Minneskliniken
Malmoe, Sweden, SE-20502
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
Mölndal, Sweden, 431 41
Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med
Stockholm, Sweden, 14186
Switzerland
Universitäres Zentrum für Altersmedizin und Rehabilitation
Basel, Switzerland, 4002
Turkey
Hacettepe University School of Medicine; Neurology
Ankara, Turkey, 06100
Osmangazi University School of Medicine,Neurology Department
Eskişehir, Turkey, 26480
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, Turkey, 34093
Ondokuz Mayis University School of Medicine; Neurology
Samsun, Turkey, 55139
Ukraine
Regional mental hospital; Department of psychiatry, psychology and sexology
Lviv, KIEV Governorate, Ukraine, 79021
National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1
Kiev, Ukraine, 04112
D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System
Kiev, Ukraine, 04114
United Kingdom
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
Chertsey, United Kingdom, KT16 0AE
Coventry and Warwickshire Partnership NHS Trust
Coventry, United Kingdom, CV6 6NY
St George's Hospital
London, United Kingdom, SW17 0QT
Charing Cross Hospital
London, United Kingdom, W6 8RF
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Campus for Ageing and Vitality
Newcastle Upon Tyne, United Kingdom, NE4 6BE
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Torbay Hospital
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02670083     History of Changes
Other Study ID Numbers: BN29552
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

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