Clinical trial NCT03114657: A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 806
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).


Eligibility 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 (up to 4 weeks before screening begins) or screening (FCSRT cueing index =\<0.67 AND free recall =\<27)
* 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
* Participant must have completed at least 6 years of formal education after the age of 5 years

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
* Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
* Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
* 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

Primary outcomes:
measure: Change From Baseline to Week 77 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score
timeFrame: Baseline, Week 77
Secondary outcomes:
measure: Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Subscale Score
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 11 (ADAS-Cog-11) Subscale Score
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS)
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE)
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 77 on Function as Assessed by (ADCS-ADL) Total Score
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 77 on Function as Assessed by (ADCS-iADL) Instrumental Score
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 77 on Function as Assessed by the Functional Activities Questionnaire (FAQ) Total Score
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 77 on a Measure of Dependence Level Assessed From the ADCS-ADL Score
timeFrame: Baseline, Week 77
measure: Change From Baseline to Week 53 on Behavior in Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Score
timeFrame: Baseline, Week 53
measure: Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score
timeFrame: Baseline, Week 77
measure: Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score
timeFrame: Baseline, Week 53
measure: European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Participants
timeFrame: Baseline, Week 77
measure: European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Caregivers
timeFrame: Baseline, Week 77
measure: Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs)
timeFrame: Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
measure: Percentage of Participants With Anti-Crenezumab Antibodies
timeFrame: Baseline up to Week 105
measure: Serum Concentration of Crenezumab
timeFrame: Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13 (Pre-dose), 37 (Pre-dose), 53 (Pre-dose) and 77 (Pre-dose) (infusion length = as per the Pharmacy Manual)
measure: Plasma Amyloid Beta (Abeta) 40 Concentrations
timeFrame: Week 1 Day 1; Weeks 53
measure: Plasma Amyloid Beta (Abeta) 42 Concentrations
timeFrame: Week 1 Day 1; Weeks 53
measure: Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, Week 105
measure: Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, Week 105
measure: Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, Week 105
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Imaging End Points Clinical Research
state: Arizona
city: Fayetteville
country: United States
facility: Health Initiatives Research, PLLC
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Trials Inc.
state: Arkansas
city: Pasadena
country: United States
facility: Neuro-Therapeutics Inc.
state: California
city: Rancho Mirage
country: United States
facility: Desert Valley Medical Group
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research, Inc.
state: California
city: Sacramento
country: United States
facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology
state: California
city: San Francisco
country: United States
facility: UCSF - Memory and Aging Center
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Stamford
country: United States
facility: KI Health Partners, LLC; New England Institute for Clinical Research
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Atlantis
country: United States
facility: JEM Research LLC
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research; Center of Southwest Florida
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center
state: Georgia
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials, LLC
state: Louisiana
city: Winchester
country: United States
facility: Alzheimers Disease Center; Neurology
state: Massachusetts
city: Saint Paul
country: United States
facility: Health Partners Institute for Education and Research
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
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: Summit
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: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
city: Charlotte
country: United States
facility: Behavioral Health Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience
state: Ohio
city: Columbus
country: United States
facility: Ohio State University; College of Medicine
state: Ohio
city: Dayton
country: United States
facility: Dayton Center for Neuro Disorders
state: Ohio
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Plains
country: United States
facility: Northeastern Pennsylvania Memory
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Cordova
country: United States
facility: Neurology Clinic PC
state: Tennessee
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research, LLC
state: Texas
city: Dallas
country: United States
facility: Texas Neurology PA
state: Texas
city: Dallas
country: United States
facility: Kerwin Research Center, LLC
state: Texas
city: Houston
country: United States
facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Inc.-Richmond
state: Virginia
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Caba
country: Argentina
facility: Universidad Maimonides
city: Cordoba
country: Argentina
facility: DAMIC
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Erina
country: Australia
facility: Central Coast Neurosciences Research
state: New South Wales
city: Hornsby
country: Australia
facility: Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
state: New South Wales
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital; Neurology
state: South Australia
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Brasilia
country: Brazil
facility: CCBR - Brasilia
state: DF
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - UFMG
state: MG
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: PR
city: Rio de Janeiro
country: Brazil
facility: Centro Psiquiatria Sandra Ruschel Ltda
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Sao Paulo
country: Brazil
facility: Clínica Dr. Norton Sayeg LTDA - EPP
state: SP
city: Kelowna
country: Canada
facility: OCT Research ULC
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research-Halifax
state: Nova Scotia
city: Kentville
country: Canada
facility: True North Clinical Research Kentville
state: Nova Scotia
city: Kingston
country: Canada
facility: Providence Care; Mental Health Services
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital; Geriatric Medicine
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Centre - Redefining Healthy Aging
state: Ontario
city: Toronto
country: Canada
facility: The Centre for Memory and Aging
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research Inc.
state: Ontario
city: Greenfield Park
country: Canada
facility: Clinique Neuro Rive-Sud
state: Quebec
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Beijing
country: China
facility: Beijing Union Hospital
city: Tianjin (天津)
country: China
facility: Tianjin Medical University General Hospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
city: København Ø
country: Denmark
facility: Rigshospitalet, Hukommelsesklinikken
city: Tallinn
country: Estonia
facility: Laane-Tallinna Keskhaigla
city: Bordeaux
country: France
facility: Hopital Pellegrin; Cmrr Aquitaine
city: Colmar
country: France
facility: Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie
city: Lille
country: France
facility: Hopital Roger Salengro; Service de Neurologie
city: Limoges
country: France
facility: CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
city: Paris
country: France
facility: Hopital Broca
city: Paris
country: France
facility: CH Pitie Salpetriere; IM2A
city: Reims
country: France
facility: Hôpital Maison Blanche
city: Rennes
country: France
facility: CHU Rennes - Hopital Pontchaillou
city: Rouen
country: France
facility: CHU de Rouen Hopital; Service de Neurologie
city: St Herblain
country: France
facility: Hop Guillaume Et Rene Laennec; Cmrr St Herblain
city: Villeurbanne
country: France
facility: Hopital des Charpennes
city: Berlin
country: Germany
facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
city: Frankfurt
country: Germany
facility: Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
city: Leipzig
country: Germany
facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center; Psychiatry Department
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center; Department of Neurology
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
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: Castellanza
country: Italy
facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
state: Lombardia
city: Passirana
country: Italy
facility: Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
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: Pisa
country: Italy
facility: A.O. Universitaria Pisana; Neurologia
state: Toscana
city: Aichi
country: Japan
facility: National Center for Geriatrics and Gerontology
city: Chiba
country: Japan
facility: Inage Neurology and Memory Clinic
city: Fukuoka
country: Japan
facility: Fukuoka Mirai Hospital
city: Hiroshima
country: Japan
facility: National Hospital Organization Hiroshima-Nishi Medical Center
city: Hyogo
country: Japan
facility: Tsukazaki Hospital
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
city: Kagawa
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Kanagawa
country: Japan
facility: Fujisawa City Hospital
city: Kanagawa
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
city: Kyoto
country: Japan
facility: Ijinkai Takeda General Hospital
city: Kyoto
country: Japan
facility: Rakuwakai Otowarehabilitation Hospital
city: Nagano
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Okayama
country: Japan
facility: Katayama Medical Clinic
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Asakayama General Hospital
city: Shizuoka
country: Japan
facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders
city: Tokyo
country: Japan
facility: Kanto Central Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Shinjuku Research Park Clinic
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Geriatric Hospital
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University 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: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF; Nevroklinikken S203
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken
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: Bydgoszcz
country: Poland
facility: NZOZ Dom Sue Ryder
city: Szczecin
country: Poland
facility: Centrum Medyczne Euromedis Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Wrocław
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: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano; Servico de Neurologia
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio; Servico de Neurologia
city: Saint-Petersburg
country: Russian Federation
facility: LLC Baltic Medicine
state: Sankt Petersburg
city: Ekaterinburg
country: Russian Federation
facility: State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita
state: Sverdlovsk
city: Kazan
country: Russian Federation
facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center
city: Kazan
country: Russian Federation
facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center
city: Moscow
country: Russian Federation
facility: Institution of RAMS (Mental Health Research Center of RAMS)
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Psychiatry Hospital #1
city: St Petersburg
country: Russian Federation
facility: St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy
city: Tomsk
country: Russian Federation
facility: Nebbiolo Center for Clinical Trials
city: Belgrade
country: Serbia
facility: Clinic for Mental disorders Dr Laza Lazarevic
city: Belgrade
country: Serbia
facility: Neurology clinic, Clinical Center of Serbia
city: Kragujevac
country: Serbia
facility: Clinic for neurology, Clinical Center Kragujevac
city: Johannesburg
country: South Africa
facility: Private Practice; the Osteoporosis Clinic
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Neurología
state: Alicante
city: BArcelon
country: Spain
facility: Fundació ACE
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: Salt
country: Spain
facility: Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies
state: Girona
city: Donosti-San Sebastián
country: Spain
facility: Policlínica Guipuzkoa; Servicio de Neurología
state: Guipuzcoa
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia
state: LA Coruña
city: Logroño
country: Spain
facility: Hospital San Pedro; Servicio de Neurología
state: LA Rioja
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: BaraKaldo
country: Spain
facility: CAE Oroitu
state: Vizcaya
city: Albacete
country: Spain
facility: Hospital Perpetuo Socorro, Servicio de Geriatria
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos. Servicio de Neurología
city: Castellon
country: Spain
facility: Hospital la Magdalena; Servicio de Neurologia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Neurologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Neurologia
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia
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: Changhua County
country: Taiwan
facility: Changhua Christian Hospital; Neurology
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital; Neurology
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital - Neurology
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital; Neurology
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Foundation - Linkou - Neurology
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Neurology
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul School of Medicine; Neurology
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.; Neurology
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; Brain Science Research Unit
city: Crowborough
country: United Kingdom
facility: Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital; Clinical Research Facility
city: London
country: United Kingdom
facility: RE:Cognition Health
city: London
country: United Kingdom
facility: Charing Cross Hospital; Imperial Memory Unit, Level 10 West
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
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:
citation: Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohorquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Nov 1;79(11):1113-1121. doi: 10.1001/jamaneurol.2022.2909.