Clinical trial NCT04374253: A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
Official title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 1382
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

Detailed description: Participants who were in the active arm in the double blind part and those who have completed OLE part in the parent study, will continue receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W). Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme as in the parent study before receiving target dose of open label gantenerumab.

Eligibility criteria: Inclusion Criteria:

* Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
* The participant should be capable of completing assessments either alone or with the help of the caregiver
* Availability of a person (referred to as the "caregiver")
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of \<1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
* Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
* Prematurely discontinued from Study WN29922 or WN39658
* Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
* Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
* Evidence of disseminated leptomeningeal hemosiderosis
* Evidence of intracerebral macrohemorrhage
* Use of prohibited medication
* Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part

Primary outcomes:
measure: Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE)
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
measure: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
measure: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
measure: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
measure: Number of Participants With Injection-Site Reactions (ISRs)
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
measure: Number of Participants Who Discontinued the Study Due an AE
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
measure: Number of Participants With at Least One Adverse Event of Special Interest (AESI)
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Secondary outcomes:
measure: Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS)
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB)
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change From Baseline Over Time in Verbal Fluency Task Score
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change From Baseline Over Time in Coding (Digit Symbol Substitution Test [DSST]) Subset
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change in Functional Activities Questionnaire (FAQ) Score
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score
timeFrame: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
measure: Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab
timeFrame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer?s Institute
state: Arizona
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Insitute
state: Arizona
city: Fayetteville
country: United States
facility: Health Initiatives Research, PLLC
state: Arkansas
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: Redlands
country: United States
facility: Desert Valley Research
state: California
city: Sacramento
country: United States
facility: Sutter Medical Group, Neurology
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc
state: California
city: Simi Valley
country: United States
facility: Southern California Research LLC
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Atlantis
country: United States
facility: JEM Research LLC
state: Florida
city: Bradenton
country: United States
facility: Accel Research Sites - CRU Tampa
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research, Inc.
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Miami
country: United States
facility: Optimus U Corp
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute, Inc
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Wellington
country: United States
facility: Alzheimer?s Research and Treatment Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University, School of Medicine
state: Illinois
city: Avon
country: United States
facility: American Health Network Institute, LLC
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Wichita
country: United States
facility: Via Christi Research
state: Kansas
city: Boston
country: United States
facility: Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Bolivar
country: United States
facility: Missouri Memory Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center; Dept of Neurological Sciences
state: Nebraska
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo; Center for Brain Research
state: Nevada
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ
state: New Jersey
city: Lake Success
country: United States
facility: Neurological Associates of Long Island, PC
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: AD-CARE, University of Rochester Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Behavioral Health Research
state: North Carolina
city: Matthews
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University; College of Medicine
state: Ohio
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: Kerwin Medical Center
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas; Research Department
state: Texas
city: Houston
country: United States
facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Neurology Specialists
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Inc.-Richmond
state: Virginia
city: Madison
country: United States
facility: UW Wisconsin-Madison
state: Wisconsin
city: Caba
country: Argentina
facility: Hospital Italiano
city: Caba
country: Argentina
facility: Universidad Maimonides
city: Capital Federal
country: Argentina
facility: Instituto Geriatrico Nuestra Señora de las Nieves
city: Cordoba
country: Argentina
facility: CEN Centro Especializado en Neurociencias
city: Córdoba
country: Argentina
facility: Instituto Kremer
city: La Plata
country: Argentina
facility: Instituto de Neurociencias San Agustín S.A.
city: Mendoza
country: Argentina
facility: Fundación Scherbovsky; General Department
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney; Neurology
state: New South Wales
city: Erina
country: Australia
facility: Central Coast Neurosciences Research
state: New South Wales
city: Kogarah
country: Australia
facility: Southern Neurology
state: New South Wales
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital; Neurology
state: South Australia
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Research Foundation
state: Western Australia
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius (Dendermonde)
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
state: PR
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: PR
city: Maringa
country: Brazil
facility: Clinica Clinilive ltda
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP_X; Neurologia
state: SP
city: Vancouver
country: Canada
facility: The Medical Arts Health Research Group - West Vancouver
state: British Columbia
city: London
country: Canada
facility: Parkwood Hospital; Geriatric Medicine
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research
state: Ontario
city: Greenfield Park
country: Canada
facility: Center for Diagnosis and Research on Alzheimer's disease
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Antofagasta
country: Chile
facility: Psicomed Estudios Médicos
city: Santiago
country: Chile
facility: Biomedica Research Group
city: Santiago
country: Chile
facility: Especialidades Medicas LYS
city: Beijing City
country: China
facility: Beijing Tian Tan Hospital,Capital Medical University
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken
city: København Ø
country: Denmark
facility: Rigshospitalet, Hukommelsesklinikken
city: Svendborg
country: Denmark
facility: Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn
city: Helsinki
country: Finland
facility: Terveystalo Ruoholahti
city: Kuopio
country: Finland
facility: Itä-Suomen yliopisto, Kuopion kampus
city: Amiens Cedex1
country: France
facility: CHU Amiens Hopital Sud; Neurologie
city: Bobigny Cedex
country: France
facility: Hôpital Avicenne; Centre de Recherche Clinique
city: Bron cedex
country: France
facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
city: Marseille
country: France
facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie
city: Paris
country: France
facility: Hôpital Lariboisière
city: Poitiers
country: France
facility: CHU Poitiers - Hopital La Miletrie
city: Strasbourg
country: France
facility: CHU Strasbourg Hôpital Hautepierre
city: Toulouse
country: France
facility: Gerontopole; Centre de Recherche clinique
city: Villeurbanne
country: France
facility: Hopital des Charpennes
city: Berlin
country: Germany
facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin
city: Berlin
country: Germany
facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
city: Köln
country: Germany
facility: Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
city: Leipzig
country: Germany
facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Klinik für Neurologie
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
city: Witten
country: Germany
facility: Forschungszentrum Ruhr
city: Budapest
country: Hungary
facility: Semmelweis University; Department of Neurology
city: Modena
country: Italy
facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
state: Lazio
city: Roma
country: Italy
facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza
state: Lazio
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
state: Lazio
city: Brescia
country: Italy
facility: IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Neurologia
state: Lombardia
city: Pozzilli
country: Italy
facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
state: Molise
city: Torino
country: Italy
facility: AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
state: Piemonte
city: Palermo
country: Italy
facility: Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
state: Sicilia
city: Aichi
country: Japan
facility: Yachiyo Hospital
city: Aichi
country: Japan
facility: Nagoya Ekisaikai Hospital
city: Aichi
country: Japan
facility: National Center for Geriatrics and Gerontology
city: Chiba
country: Japan
facility: Medical Corporation Hakuyokai Kashiwado Hospital
city: Chiba
country: Japan
facility: Tokyo Bay Advanced Medical and Makuhari Clinic
city: Chiba
country: Japan
facility: Inage Neurology and Memory Clinic
city: Chiba
country: Japan
facility: Juntendo University Urayasu Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukushima
country: Japan
facility: Southern Tohoku Medical Clinic
city: Hiroshima
country: Japan
facility: National Hospital Organization Hiroshima-Nishi Medical Center
city: Hyogo
country: Japan
facility: Kobe University Hospital
city: Hyogo
country: Japan
facility: Hyogo Prefectural HarimaHimeji General Medical Center
city: Hyogo
country: Japan
facility: Tsukazaki Hospital
city: Hyogo
country: Japan
facility: Matsui Dietary and Dementia Clinic
city: Kagawa
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
city: Kyoto
country: Japan
facility: Rakuwakai Otowa Hospital
city: Kyoto
country: Japan
facility: Uji Takeda Hospital
city: Okayama
country: Japan
facility: Okayama Kyokuto Hospital
city: Okayama
country: Japan
facility: Rijikai Medical Corporation Katayama Medical Clinic
city: Osaka
country: Japan
facility: MI Clinic
city: Osaka
country: Japan
facility: Kishiwada Tokushukai Hospital
city: Saga
country: Japan
facility: National Hospital Organization Hizen Psychiatric Medical Center
city: Shizuoka
country: Japan
facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders
city: Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital
city: Tochigi
country: Japan
facility: Jichiidai Station Brain Clinic
city: Tokushima
country: Japan
facility: Medical corporation Ichiekai Itsuki Hospital
city: Tokushima
country: Japan
facility: Tokushima Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Nozomi Memory Clinic
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Tokyo
country: Japan
facility: P-One Clinic
city: Yamagata
country: Japan
facility: Yamagata Tokusyukai Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Myongji Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Hospital (Seoul)
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics; Neurology
city: Ciudad de México
country: Mexico
facility: Mexico Centre for Clinical Research
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: AVIX Investigación Clínica S.C
state: Nuevo LEON
city: Culiacán
country: Mexico
facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
state: Sinaloa
city: Amsterdam
country: Netherlands
facility: Brain Research Center B.V
city: Bellavista
country: Peru
facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
city: Lima
country: Peru
facility: Clinica Internacional; Unidad De Investigacion
city: Lima
country: Peru
facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
city: ?cinawa
country: Poland
facility: O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
city: Bia?ystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Katowice
country: Poland
facility: NEURO-CARE Sp. z o.o. Sp. Komandytowa
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Plewiska
country: Poland
facility: Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
city: Sopot
country: Poland
facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna
city: Warszawa
country: Poland
facility: mMED Maciej Czarnecki
city: Warszawa
country: Poland
facility: Pratia S.A.
city: Wroc?aw
country: Poland
facility: NZOZ WCA
city: Braga
country: Portugal
facility: Hospital de Braga; Servico de Neurologia
city: Coimbra
country: Portugal
facility: HUC; Servico de Neurologia
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio; Servico de Neurologia
city: Bayamon
country: Puerto Rico
facility: Santa Cruz Behavioral PSC
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico - Medical Science Campus; Internal Medicine
city: Krasnoyarsk
country: Russian Federation
facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
state: Krasnojarsk
city: Moscow
country: Russian Federation
facility: University ?linic of headaches
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: City Clin Hosp n.a. S.P.Botkin
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow
state: Moskovskaja Oblast
city: Sankt-peterburg
country: Russian Federation
facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: Vertebronevrologiya LLC
state: Tatarstan
city: Kazan
country: Russian Federation
facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center
state: Tatarstan
city: Saratov
country: Russian Federation
facility: MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric
city: Tomsk
country: Russian Federation
facility: Nebbiolo Center for Clinical Trials
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Neurología
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Neurologia
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Hospital General De Catalunya; Servicio de Neurologia
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua De Terrasa; Servicio de Neurologia
state: Barcelona
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto. Servicio de Neurología
state: Caceres
city: SANtander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología
state: Cantabria
city: Donostia-san Sebastian
country: Spain
facility: Policlínica Guipuzcoa; Servicio de Neurología
state: Guipuzcoa
city: Logroño
country: Spain
facility: Hospital San Pedro; Servicio de Neurología
state: LA Rioja
city: Lleida
country: Spain
facility: Hospital Universitario de Santa Maria; Servicio de Neurología
state: Lerida
city: Móstoles
country: Spain
facility: HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid; Servicio de Neurologia
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Neurología
state: Navarra
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Getxo
country: Spain
facility: CAE OROITU; Servicio de Neurología
state: Vizcaya
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete; Servicio de Neurología
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Neurologia
city: Barcelona
country: Spain
facility: Fundación ACE; Servicio de Neurología
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron; Servicio de Neurología
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial; Servicio de Neurologia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Neurologia
city: Madrid
country: Spain
facility: Universitario de La Princesa; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Neurologia
city: Madrid
country: Spain
facility: Hospital Ruber Internacional; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío; Servicio de Neurología
city: Sevilla
country: Spain
facility: Hospital Victoria Eugenia; Servico Neurología
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Neurologia
city: Zamora
country: Spain
facility: Complejo Asistencial de Zamora; Servicio Psiquiatria
city: Zaragoza
country: Spain
facility: Servicio de Neurología Hospital Viamed Montecanal.
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus Malmö, Minneskliniken
city: Mölndal
country: Sweden
facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
city: Stockholm
country: Sweden
facility: KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital; Neurology
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital; Neurology
city: Niaosong Dist.
country: Taiwan
facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology
city: North Dist.
country: Taiwan
facility: China Medical University Hospital; Neurology
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital; Neurology
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Foundation - Linkou - Neurology
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.; Neurology
city: Bath
country: United Kingdom
facility: The Rice Centre; Royal United Hospital
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health Birmingham
city: Cheltenham
country: United Kingdom
facility: The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
city: Chertsey
country: United Kingdom
facility: Surrey and Borders NHS Foundation Trust; Research and Development Department
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital - PPDS
city: London
country: United Kingdom
facility: St George?s Hospital
city: London
country: United Kingdom
facility: Re:Cognition Health London
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Newcastle
country: United Kingdom
facility: Campus for Ageing and Vitality
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Southampton NHS Foundation Trust; Wessex Neurologica Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: