A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
NCT ID: NCT03114657
Last Updated: 2020-07-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
806 participants
INTERVENTIONAL
2017-03-29
2019-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
Placebo
Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Crenezumab
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
Crenezumab
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Interventions
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Crenezumab
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Placebo
Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
85 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Imaging End Points Clinical Research
Scottsdale, Arizona, United States
Health Initiatives Research, PLLC
Fayetteville, Arkansas, United States
Clinical Trials Inc.
Little Rock, Arkansas, United States
Neuro-Therapeutics Inc.
Pasadena, California, United States
Desert Valley Medical Group
Rancho Mirage, California, United States
Anderson Clinical Research, Inc.
Redlands, California, United States
University of California, Davis; Alzheimers Disease Center, Department of Neurology
Sacramento, California, United States
UCSF - Memory and Aging Center
San Francisco, California, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
JEM Research LLC
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Columbus Memory Center
Columbus, Georgia, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States
Alzheimers Disease Center; Neurology
Winchester, Massachusetts, United States
Health Partners Institute for Education and Research
Saint Paul, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
University of Nebraska Medical Center; Dept of Neurological Sciences
Omaha, Nebraska, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States
The Cognitive and Research Center of New Jersey
Summit, New Jersey, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Burke Rehabilitation Hospital
White Plains, New York, United States
Behavioral Health Research
Charlotte, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States
Ohio State University; College of Medicine
Columbus, Ohio, United States
Dayton Center for Neuro Disorders
Dayton, Ohio, United States
Summit Research Network Inc.
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Northeastern Pennsylvania Memory
Plains, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Neurology Clinic PC
Cordova, Tennessee, United States
Senior Adults Specialty Research
Austin, Texas, United States
Gadolin Research, LLC
Beaumont, Texas, United States
Texas Neurology PA
Dallas, Texas, United States
Kerwin Research Center, LLC
Dallas, Texas, United States
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Sentara Medical Group
Norfolk, Virginia, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States
Hospital Italiano
Buenos Aires, , Argentina
Universidad Maimonides
Caba, , Argentina
DAMIC
Córdoba, , Argentina
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Central Coast Neurosciences Research
Erina, New South Wales, Australia
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
Hornsby, New South Wales, Australia
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, Australia
AZ Sint Jan
Bruges, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CCBR - Brasilia
Brasília, Federal District, Brazil
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Centro Psiquiatria Sandra Ruschel Ltda
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Clínica Dr. Norton Sayeg LTDA - EPP
São Paulo, São Paulo, Brazil
OCT Research ULC
Kelowna, British Columbia, Canada
Vancouver Island Health Authority
Victoria, British Columbia, Canada
True North Clinical Research-Halifax
Halifax, Nova Scotia, Canada
True North Clinical Research Kentville
Kentville, Nova Scotia, Canada
Providence Care; Mental Health Services
Kingston, Ontario, Canada
Parkwood Hospital; Geriatric Medicine
London, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
The Centre for Memory and Aging
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
ALPHA Recherche Clinique
Québec, , Canada
Beijing Union Hospital
Beijing, , China
Tianjin Medical University General Hospital
Tianjin (天津), , China
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
Aarhus N, , Denmark
Rigshospitalet, Hukommelsesklinikken
København Ø, , Denmark
Laane-Tallinna Keskhaigla
Tallinn, , Estonia
Hopital Pellegrin; Cmrr Aquitaine
Bordeaux, , France
Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie
Colmar, , France
Hopital Roger Salengro; Service de Neurologie
Lille, , France
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
Limoges, , France
Hopital Broca
Paris, , France
CH Pitie Salpetriere; IM2A
Paris, , France
Hôpital Maison Blanche
Reims, , France
CHU Rennes - Hopital Pontchaillou
Rennes, , France
CHU de Rouen Hopital; Service de Neurologie
Rouen, , France
Hop Guillaume Et Rene Laennec; Cmrr St Herblain
Saint-Herblain, , France
Hopital des Charpennes
Villeurbanne, , France
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, , Germany
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
Frankfurt, , Germany
Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie
Freiburg im Breisgau, , Germany
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
Homburg/Saar, , Germany
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Leipzig, , Germany
Pharmakologisches Studienzentrum
Mittweida, , Germany
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, , Germany
Rambam Medical Center
Haifa, , Israel
Sheba Medical Center; Psychiatry Department
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
Rome, Lazio, Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, Italy
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Rome, Lazio, Italy
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
Brescia, Lombardy, Italy
Irccs Multimedica Santa Maria; Unita' Di Neurologia
Castellanza, Lombardy, Italy
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia
Milan, Lombardy, Italy
Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
Milan, Lombardy, Italy
Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
Passirana, Lombardy, Italy
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Pozzilli, Molise, Italy
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
Turin, Piedmont, Italy
A.O. Universitaria Pisana; Neurologia
Pisa, Tuscany, Italy
National Center for Geriatrics and Gerontology
Aichi, , Japan
Inage Neurology and Memory Clinic
Chiba, , Japan
Fukuoka Mirai Hospital
Fukuoka, , Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, , Japan
Tsukazaki Hospital
Hyōgo, , Japan
Kagawa Prefectural Central Hospital
Kagawa, , Japan
Fujisawa City Hospital
Kanagawa, , Japan
National Hospital Organization Sagamihara National Hospital
Kanagawa, , Japan
Ijinkai Takeda General Hospital
Kyoto, , Japan
Rakuwakai Otowarehabilitation Hospital
Kyoto, , Japan
National Hospital Organization Matsumoto Medical Center
Nagano, , Japan
Iwate Medical University Hospital
Numakunai, , Japan
Katayama Medical Clinic
Okayama, , Japan
Osaka University Hospital
Osaka, , Japan
Asakayama General Hospital
Osaka, , Japan
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, , Japan
Kanto Central Hospital
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Shinjuku Research Park Clinic
Tokyo, , Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, , Japan
Akershus universitetssykehus HF; Nevroklinikken S203
Lørenskog, , Norway
Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken
Oslo, , Norway
Clinica Internacional; Unidad De Investigacion
Lima, , Peru
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Lima, , Peru
NZOZ Dom Sue Ryder
Bydgoszcz, , Poland
Centrum Medyczne Euromedis Sp. z o.o.
Szczecin, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
NZOZ WCA
Wroclaw, , Poland
Hospital de Braga; Servico de Neurologia
Braga, , Portugal
HUC; Servico de Neurologia
Coimbra, , Portugal
Hospital Pedro Hispano; Servico de Neurologia
Matosinhos Municipality, , Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, , Portugal
LLC Baltic Medicine
Saint Petersburg, Sankt-Peterburg, Russia
State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita
Yekaterinburg, Sverdlovsk Oblast, Russia
State Autonomous Healthcare Institution "Republican Clinical Neurological Center
Kazan', , Russia
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan', , Russia
Institution of RAMS (Mental Health Research Center of RAMS)
Moscow, , Russia
City Clinical Psychiatry Hospital #1
Nizhny Novgorod, , Russia
St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy
Saint Petersburg, , Russia
Nebbiolo Center for Clinical Trials
Tomsk, , Russia
Clinic for Mental disorders Dr Laza Lazarevic
Belgrade, , Serbia
Neurology clinic, Clinical Center of Serbia
Belgrade, , Serbia
Clinic for neurology, Clinical Center Kragujevac
Kragujevac, , Serbia
Private Practice; the Osteoporosis Clinic
Johannesburg, , South Africa
Dong-A University Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Borame Medical Center
Seoul, , South Korea
Hospital General Universitario de Elche; Servicio de Neurología
Elche, Alicante, Spain
Fundació ACE
BArcelon, Barcelona, Spain
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Vallès, Barcelona, Spain
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrassa, Barcelona, Spain
Hospital Virgen del Puerto. Servicio de Neurología
Plasencia, Caceres, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
Santander, Cantabria, Spain
Hospital la Magdalena; Servicio de Neurologia
Castellon, Castellon, Spain
Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies
Salt, Girona, Spain
Policlínica Guipuzkoa; Servicio de Neurología
Donosti-San Sebastián, Guipuzcoa, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia
Santiago de Compostela, LA Coruña, Spain
Hospital San Pedro; Servicio de Neurología
Logroño, La Rioja, Spain
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcón, Madrid, Spain
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarre, Spain
CAE Oroitu
Barakaldo, Vizcaya, Spain
Hospital Perpetuo Socorro, Servicio de Geriatria
Albacete, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, , Spain
Hospital Universitario de Burgos. Servicio de Neurología
Burgos, , Spain
Hospital Universitario Reina Sofia; Servicio de Neurologia
Córdoba, , Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla
Salamanca, , Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Seville, , Spain
Skånes Universitetssjukhus Malmö, Minneskliniken
Malmo, , Sweden
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
Mölndal, , Sweden
Changhua Christian Hospital; Neurology
Changhua County, , Taiwan
Kaohsiung Medical University Hospital; Neurology
Kaohsiung City, , Taiwan
Taipei Medical University - Shuang Ho Hospital - Neurology
New Taipei City, , Taiwan
National Taiwan University Hospital; Neurology
Taipei, , Taiwan
Chang Gung Memorial Foundation - Linkou - Neurology
Taoyuan District, , Taiwan
Hacettepe University Medical Faculty; Neurology
Ankara, , Turkey (Türkiye)
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, , Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, , Turkey (Türkiye)
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
Cheltenham, , United Kingdom
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
Chertsey, , United Kingdom
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
Crowborough, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
Edinburgh, , United Kingdom
Queen Elizabeth University Hospital; Clinical Research Facility
Glasgow, , United Kingdom
RE:Cognition Health
London, , United Kingdom
Charing Cross Hospital; Imperial Memory Unit, Level 10 West
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
University Southampton NHS Foundation Trust; Wessex Neurologica Centre
Southampton, , United Kingdom
Countries
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References
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Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
Teng E, Manser PT, Shah M, Pickthorn K, Hu N, Djakovic S, Swendsen H, Blendstrup M, Faccin G, Ostrowitzki S, Sink KM. The Use of Episodic Memory Tests for Screening in Clinical Trials for Early Alzheimer's Disease: A Comparison of the Free and Cued Selective Reminding Test (FCSRT) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). J Prev Alzheimers Dis. 2023;10(1):41-49. doi: 10.14283/jpad.2022.101.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-003288-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BN29553
Identifier Type: -
Identifier Source: org_study_id
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