Clinical trial NCT02670083: A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo 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: 2016-02-01
Enrollment: 813
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 final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.


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 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score
timeFrame: Baseline, Week 105
Secondary outcomes:
measure: Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 13 (ADAS-Cog-13)
timeFrame: Baseline, Week 105
measure: Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 11 (ADAS-Cog-11)
timeFrame: Baseline, Week 105
measure: Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS)
timeFrame: Baseline, Week 105
measure: Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE)
timeFrame: Baseline, Week 105
measure: Change From Baseline to Week 105 on Function as Assessed by the ADCS-ADL Total Score
timeFrame: Baseline, Week 105
measure: Change From Baseline to Week 105 on Function as Assessed by the ADCS-instrumental (ADCS-iADL) Subscore
timeFrame: Baseline, Week 105
measure: Change From Baseline to Week 105 on a Measure of Dependence Derived From the ADCS-ADL Score
timeFrame: Baseline, Week 105
measure: Change From Baseline to Week 105 Assessed Using the Neuropsychiatric Inventory Questionnaire (NPI-Q)
timeFrame: Baseline, Week 105
measure: Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score
timeFrame: Baseline up to Week 105
measure: Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score
timeFrame: Baseline up to Week 105
measure: EQ-5D Questionnaire Domain Score for Participants
timeFrame: Baseline up to Week 105
measure: EQ-5D Questionnaire Domain Score for Caregivers
timeFrame: Baseline up to Week 105
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, 37 (Pre-dose), 53, 77 and 105 (infusion length = as per the Pharmacy Manual)
measure: Plasma Amyloid Beta (Abeta) 40 Concentrations
timeFrame: Week 1 Day 1; Weeks 13, 25, 53, 77 and 105
measure: Plasma Amyloid Beta (Abeta) 42 Concentrations
timeFrame: Week 1 Day 1; Weeks 13, 25, 53, 77 and 105
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: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Inst
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: Long Beach
country: United States
facility: Alliance for Wellness, dba Alliance for Research
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: USC Keck School Of Medicine
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center, Department of Neurology
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Inst
state: California
city: Newport Beach
country: United States
facility: Shankle Clinic
state: California
city: Palo Alto
country: United States
facility: Stanford Univ Medical Center
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: Santa Monica
country: United States
facility: Neurological Research Inst
state: California
city: Sebastopol
country: United States
facility: North Bay Neuro Science Institute
state: California
city: Danbury
country: United States
facility: Associated Neurologists PC - Danbury
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
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: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Deerfield Beach
country: United States
facility: Quantum Laboratories
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: Galiz Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Merritt Island
country: United States
facility: Merritt - Island Medical Research
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
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: Tampa
country: United States
facility: Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: The Villages
country: United States
facility: Compass Research
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies.net, LLC
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosci Inst
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University, School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Prairie Village
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Scarborough
country: United States
facility: MMP Neurology
state: Maine
city: Springfield
country: United States
facility: Springfield Neurology Associates
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
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: Albany
country: United States
facility: Albany Medical Faculty Physicians COmmunity Division. The Neurology Group
state: New York
city: Albany
country: United States
facility: Neurological Associates of Albany, PC
state: New York
city: Amherst
country: United States
facility: Dent Neurological Institute
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Patchogue
country: United States
facility: South Shore Neurologic Associates P.C.
state: New York
city: Charlotte
country: United States
facility: Behavioral Health Research
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Shaker Heights
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Philadelphia
country: United States
facility: Drexel Univ College of Med; Clinical Research Group
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: Kerwin Research Center, LLC
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center; Fort Worth Patient Care Center
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: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital; Neurology
state: South Australia
city: Caulfield
country: Australia
facility: Caulfield Hospital; Aged Psychiatry Research Unit
state: Victoria
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
state: Victoria
city: West Perth
country: Australia
facility: Neurodegenerative Disorders Research; Neurology
state: Western Australia
city: Linz
country: Austria
facility: Konventhospital Barmherzige Brüder; Neurologie I
city: Gent
country: Belgium
facility: UZ Gent
city: Sofia
country: Bulgaria
facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
city: Sofia
country: Bulgaria
facility: Alexandrovska hospital; Neurology Department
city: Vancouver
country: Canada
facility: Vancouver Hospital - UBC Hospital Site
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: London
country: Canada
facility: Parkwood Hospital; Geriatric Medicine
state: Ontario
city: Ottawa
country: Canada
facility: Bruyere Continuing Care
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: Toronto Western Hospital
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research Inc.
state: Ontario
city: Quebec City
country: Canada
facility: CHA Hopital de I enfant-Jesus
state: Quebec
city: San Jose
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: San José
country: Costa Rica
facility: Hospital Clínica Biblica
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb;Clinic for Neurology
city: Hradec Králové
country: Czechia
facility: Charles University, Medical faculty, Hradec Kralove ;Department of Neurology
city: Praha
country: Czechia
facility: General Teaching Hospital, Departmetn of Neurology
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
city: København Ø
country: Denmark
facility: Rigshospitalet, Hukommelsesklinikken
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Turku
country: Finland
facility: CRST Oy
city: Bobigny
country: France
facility: Hopital Avicenne; Neurologie
city: Bron
country: France
facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
city: Montpellier
country: France
facility: Hopital Gui de Chauliac; Neurologie
city: Paris
country: France
facility: Hopital Lariboisiere
city: Poitiers
country: France
facility: CHU Poitiers - Hopital La Miletrie
city: Strasbourg
country: France
facility: Hopital Hautepierre; Centre dInvestigation Clinique
city: Toulouse
country: France
facility: CHU Toulouse - La Grave
city: München
country: Germany
facility: Neurologische Praxis Dr. Andrej Pauls
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: Nürnberg
country: Germany
facility: Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie
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: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Division of Geriatric Medicine
city: Budapest
country: Hungary
facility: Semmelweis University; Department of Neurology
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria
city: Szeged
country: Hungary
facility: University of Szeged; Department of Psychiatry
city: Tatabánya
country: Hungary
facility: Szent Borbala Korhaz; Neurologiai es Stroke Osztaly
city: VAC
country: Hungary
facility: Jávorszky Ödön Kórház, Neurológia és stroke osztály
city: Roma
country: Italy
facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
state: Lazio
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
state: Lazio
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia
state: Liguria
city: Milano
country: Italy
facility: Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative
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: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria
state: Umbria
city: Hiroshima
country: Japan
facility: Miyoshi Clinic of Neurology, Hananosato
city: Hiroshima
country: Japan
facility: National Hospital Organization Hiroshima-Nishi Medical Center
city: Kyoto
country: Japan
facility: Rakuwakai Otowarehabilitation Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Nagano
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Niigata
country: Japan
facility: Saigata Medical Center
city: Okayama
country: Japan
facility: Katayama Medical Clinic
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Geriatric Hospital
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University 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: KyungHee Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital; Dept of Neurology
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic
city: Culiacan
country: Mexico
facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
city: Monterrey
country: Mexico
facility: Hospital Uni; Dr. Jose E. Gonzalez
city: Monterrey
country: Mexico
facility: AVIX Investigación Clínica S.C
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo
city: Białystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
city: Poznań
country: Poland
facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
city: Siemianowice Śląskie
country: Poland
facility: NEURO-CARE Sp. z o.o. Sp. Komandytowa
city: Warszawa
country: Poland
facility: Przychodnia Specjalistyczna PROSEN
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Warszawa
country: Poland
facility: Optimum
city: Amadora
country: Portugal
facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo; Servico de Neurologia
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: Moscow
country: Russian Federation
facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
city: Saratov
country: Russian Federation
facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky
city: St Petersburg
country: Russian Federation
facility: SHI City Psychoneurological Dispensary #7
city: St. Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
city: BArcelon
country: Spain
facility: Fundació ACE
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Neurologia
state: Barcelona
city: Manresa
country: Spain
facility: Hospital Sant Joan de Deu; Servicio de Neurología
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: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Neurología
state: Navarra
city: Salamaca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
state: Salamanca
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete; Servicio de Neurología
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron; Servicio de Neurología
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos. Servicio de Neurología
city: Madrid
country: Spain
facility: Clinica Ruber, 4 planta; Servicio de Neurologia
city: Madrid
country: Spain
facility: Universitario de La Princesa; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Neurologia
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; Dept. of Geriatric Med
city: Basel
country: Switzerland
facility: Universitäres Zentrum für Altersmedizin und Rehabilitation
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine; Neurology
city: Eskişehir
country: Turkey
facility: Osmangazi University School of Medicine,Neurology Department
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul School of Medicine; Neurology
city: Samsun
country: Turkey
facility: Ondokuz Mayis University School of Medicine; Neurology
city: Lviv
country: Ukraine
facility: Regional mental hospital; Department of psychiatry, psychology and sexology
state: KIEV Governorate
city: Kiev
country: Ukraine
facility: National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1
city: Kiev
country: Ukraine
facility: D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System
city: Blackburn
country: United Kingdom
facility: Royal Preston Hospital
city: Chertsey
country: United Kingdom
facility: Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
city: Coventry
country: United Kingdom
facility: Coventry and Warwickshire Partnership NHS Trust
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newcastle Upon Tyne
country: United Kingdom
facility: Campus for Ageing and Vitality
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
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.