A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).
NCT ID: NCT02670083
Last Updated: 2020-07-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
813 participants
INTERVENTIONAL
2016-03-22
2019-05-31
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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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Pharmacology Research Inst
Encino, California, United States
Collaborative Neuroscience Network Inc.
Long Beach, California, United States
Alliance for Wellness, dba Alliance for Research
Long Beach, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
USC Keck School Of Medicine
Los Angeles, California, United States
UCLA Medical Center, Department of Neurology
Los Angeles, California, United States
Pharmacology Research Inst
Newport Beach, California, United States
Shankle Clinic
Newport Beach, California, United States
Stanford Univ Medical Center
Palo Alto, 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
Neurological Research Inst
Santa Monica, California, United States
North Bay Neuro Science Institute
Sebastopol, California, United States
Associated Neurologists PC - Danbury
Danbury, Connecticut, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Bradenton Research Center
Bradenton, Florida, United States
Quantum Laboratories
Deerfield Beach, Florida, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Galiz Research, LLC
Hialeah, Florida, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States
Merritt - Island Medical Research
Merritt Island, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
Tampa, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Compass Research
The Villages, Florida, United States
Emory University
Atlanta, Georgia, United States
NeuroStudies.net, LLC
Decatur, Georgia, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
MidAmerica Neuroscience Institute
Prairie Village, Kansas, United States
Maine Research Associates
Auburn, Maine, United States
MMP Neurology
Scarborough, Maine, United States
Springfield Neurology Associates
Springfield, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
Albany Medical Faculty Physicians COmmunity Division. The Neurology Group
Albany, New York, United States
Neurological Associates of Albany, PC
Albany, New York, United States
Dent Neurological Institute
Amherst, New York, United States
Columbia University Medical Center
New York, New York, United States
South Shore Neurologic Associates P.C.
Patchogue, New York, United States
Behavioral Health Research
Charlotte, North Carolina, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
Valley Medical Primary Care
Centerville, Ohio, United States
Insight Clinical Trials LLC
Shaker Heights, Ohio, United States
Oklahoma Clinical Research
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Central States Research
Tulsa, Oklahoma, United States
Summit Research Network Inc.
Portland, Oregon, United States
Drexel Univ College of Med; Clinical Research Group
Philadelphia, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Senior Adults Specialty Research
Austin, Texas, United States
Kerwin Research Center, LLC
Dallas, Texas, United States
University of North Texas Health Science Center; Fort Worth Patient Care Center
Fort Worth, Texas, United States
Sentara Medical Group
Norfolk, Virginia, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, Australia
Caulfield Hospital; Aged Psychiatry Research Unit
Caulfield, Victoria, Australia
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, Australia
Neurodegenerative Disorders Research; Neurology
West Perth, Western Australia, Australia
Konventhospital Barmherzige Brüder; Neurologie I
Linz, , Austria
UZ Gent
Ghent, , Belgium
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
Sofia, , Bulgaria
Alexandrovska hospital; Neurology Department
Sofia, , Bulgaria
Vancouver Hospital - UBC Hospital Site
Vancouver, British Columbia, Canada
Vancouver Island Health Authority
Victoria, British Columbia, Canada
Parkwood Hospital; Geriatric Medicine
London, Ontario, Canada
Bruyere Continuing Care
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
The Centre for Memory and Aging
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada
CHA Hopital de I enfant-Jesus
Québec, Quebec, Canada
Hospital Clínica Biblica
San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José, , Costa Rica
Clinical Hospital Centre Zagreb;Clinic for Neurology
Zagreb, , Croatia
Charles University, Medical faculty, Hradec Kralove ;Department of Neurology
Hradec Králové, , Czechia
General Teaching Hospital, Departmetn of Neurology
Prague, , Czechia
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
Aarhus N, , Denmark
Rigshospitalet, Hukommelsesklinikken
København Ø, , Denmark
Terveystalo Tampere
Tampere, , Finland
CRST Oy
Turku, , Finland
Hopital Avicenne; Neurologie
Bobigny, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, , France
Hopital Gui de Chauliac; Neurologie
Montpellier, , France
Hopital Lariboisiere
Paris, , France
CHU Poitiers - Hopital La Miletrie
Poitiers, , France
Hopital Hautepierre; Centre dInvestigation Clinique
Strasbourg, , France
CHU Toulouse - La Grave
Toulouse, , France
Neurologische Praxis Dr. Andrej Pauls
München, , Germany
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, , Germany
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster, , Germany
Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie
Nuremberg, , Germany
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
Rostock, , Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, , Germany
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
Westerstede, , Germany
Forschungszentrum Ruhr
Witten, , Germany
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
Hong Kong, , Hong Kong
Queen Mary Hospital, Division of Geriatric Medicine
Hong Kong, , Hong Kong
Semmelweis University; Department of Neurology
Budapest, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria
Nyíregyháza, , Hungary
University of Szeged; Department of Psychiatry
Szeged, , Hungary
Szent Borbala Korhaz; Neurologiai es Stroke Osztaly
Tatabánya, , Hungary
Jávorszky Ödön Kórház, Neurológia és stroke osztály
Vác, , Hungary
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
Rome, Lazio, Italy
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Rome, Lazio, Italy
Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia
Genoa, Liguria, Italy
Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative
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
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria
Perugia, Umbria, Italy
Miyoshi Clinic of Neurology, Hananosato
Hiroshima, , Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, , Japan
Rakuwakai Otowarehabilitation Hospital
Kyoto, , Japan
Mie University Hospital
Mie, , Japan
National Hospital Organization Matsumoto Medical Center
Nagano, , Japan
Saigata Medical Center
Niigata, , Japan
Katayama Medical Clinic
Okayama, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Vilnius University Hospital Santariskiu Clinic
Vilnius, , Lithuania
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Culiacán, , Mexico
Hospital Uni; Dr. Jose E. Gonzalez
Monterrey, , Mexico
AVIX Investigación Clínica S.C
Monterrey, , Mexico
Hospital Universitario de Saltillo
Saltillo, , Mexico
Podlaskie Centrum Psychogeriatrii
Bialystok, , Poland
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
Poznan, , Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, , Poland
Przychodnia Specjalistyczna PROSEN
Warsaw, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
Optimum
Warsaw, , Poland
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Amadora, , Portugal
Hospital Beatriz Angelo; Servico de Neurologia
Loures, , Portugal
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
SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
Moscow, , Russia
SHI City Psychoneurological Dispensary #7
Saint Petersburg, , Russia
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
Saint Petersburg, , Russia
City Clinical Hospital # 2 n.a. V.I. Razumovsky
Saratov, , Russia
University Medical Centre Maribor
Maribor, , Slovenia
Chonnam National University Hospital
Gwangju, , South Korea
Inha University Hospital
Incheon, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
KyungHee Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital; Dept of Neurology
Seoul, , South Korea
Fundació ACE
BArcelon, Barcelona, Spain
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Sant Joan de Deu; Servicio de Neurología
Manresa, 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
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarre, Spain
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
Salamaca, Salamanca, Spain
Hospital General Universitario de Albacete; Servicio de Neurología
Albacete, , Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona, , Spain
Hospital Universitario de Burgos. Servicio de Neurología
Burgos, , Spain
Clinica Ruber, 4 planta; Servicio de Neurologia
Madrid, , Spain
Universitario de La Princesa; Servicio de Neurología
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Málaga, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
Murcia, , Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, , Spain
Servicio de Neurología Hospital Viamed Montecanal.
Zaragoza, , Spain
Skånes Universitetssjukhus Malmö, Minneskliniken
Malmo, , Sweden
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
Mölndal, , Sweden
Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med
Stockholm, , Sweden
Universitäres Zentrum für Altersmedizin und Rehabilitation
Basel, , Switzerland
Hacettepe University School of Medicine; Neurology
Ankara, , Turkey (Türkiye)
Osmangazi University School of Medicine,Neurology Department
Eskişehir, , Turkey (Türkiye)
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, , Turkey (Türkiye)
Ondokuz Mayis University School of Medicine; Neurology
Samsun, , Turkey (Türkiye)
Regional mental hospital; Department of psychiatry, psychology and sexology
Lviv, KIEV Governorate, Ukraine
National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1
Kiev, , Ukraine
D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System
Kiev, , Ukraine
Royal Preston Hospital
Blackburn, , United Kingdom
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
Chertsey, , United Kingdom
Coventry and Warwickshire Partnership NHS Trust
Coventry, , United Kingdom
St George's Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Campus for Ageing and Vitality
Newcastle upon Tyne, , United Kingdom
John Radcliffe Hospital
Oxford, , 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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2015-003034-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BN29552
Identifier Type: -
Identifier Source: org_study_id
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