Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
NCT ID: NCT03444870
Last Updated: 2024-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1053 participants
INTERVENTIONAL
2018-06-06
2023-02-17
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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Gantenerumab
Gantenerumab will be administered as SC injections with gradual uptitration.
Gantenerumab
Gantenerumab will be administered as per the schedule specified in the respective arm.
Placebo
Placebo will be administered as SC injections with gradual uptitration.
Placebo
Placebo will be administered as per the schedule specified in the respective arm.
Interventions
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Gantenerumab
Gantenerumab will be administered as per the schedule specified in the respective arm.
Placebo
Placebo will be administered as per the schedule specified in the respective arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid PET scan
* Demonstrated abnormal memory function
* MMSE score greater than or equal to 22 (≥ 22)
* Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0
* Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study
* If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening and until randomization
* For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
Exclusion Criteria
* History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
* History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
* History or presence of clinically evident cerebrovascular disease
* History or presence of posterior reversible encephalopathy syndrome
* History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack
* History of severe, clinically significant CNS trauma
* History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition
* Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
* History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits
* At risk for suicide in the opinion of the investigator
* Alcohol and/or substance abuse or dependants in past 2 years
* Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
* Any contraindications to brain MRI
* Unstable or clinically significant cardiovascular, kidney or liver disease
* Uncontrolled hypertension
* Unstable or clinically significant cardiovascular disease
* Abnormal thyroid function
* Patients with evidence of folic acid deficiency
Exclusion for Open-Label Extension (OLE):
* Discontinued from study treatment during the double-blind treatment period
* Received any other investigational medication during the double-blind treatment period or after the end of double-blind treatment
* Participation in the OLE deemed inappropriate by the investigator
* Presence of ARIA-E findings at the Week 116 MRI scan
50 Years
90 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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Center for Neurosciences
Tucson, Arizona, United States
Global Clinical Trials; Irvine, CA
Irvine, California, United States
Sutter Medical Group, Neurology
Sacramento, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Alzheimer?s Research and Treatment Center
Wellington, Florida, United States
Columbus Memory Center
Columbus, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Via Christi Research
Wichita, Kansas, United States
Precise Research Centers
Flowood, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
Neurological Associates of Long Island, PC
Lake Success, New York, United States
Columbia University Medical Center
New York, New York, United States
Ohio State University; College of Medicine
Columbus, Ohio, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Drexel University; College of Medicine
Philadelphia, Pennsylvania, United States
Coastal Neurology
Port Royal, South Carolina, United States
Senior Adults Specialty Research
Austin, Texas, United States
Neurology Consultants of Dallas; Research Department
Dallas, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Neurology Specialists
Norfolk, Virginia, United States
Neurological Associates, Inc.
Richmond, Virginia, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States
UW Wisconsin-Madison
Madison, Wisconsin, United States
St Vincent's Hospital Sydney; Neurology
Darlinghurst, New South Wales, Australia
Central Coast Neurosciences Research
Erina, New South Wales, Australia
Southern Neurology
Kogarah, New South Wales, Australia
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, Australia
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, Australia
Neuro Trials Victoria
Noble Park, Victoria, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia
Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
Curitiba, Paraná, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Clinica Clinilive ltda
Maringá, Paraná, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Clínica Dr. Norton Sayeg LTDA - EPP
São Paulo, São Paulo, Brazil
Hospital das Clinicas - FMUSP_X; Neurologia
São Paulo, São Paulo, Brazil
Medical Arts Health Research Group
Penticton, British Columbia, Canada
The Medical Arts Health Research Group - West Vancouver
Vancouver, British Columbia, Canada
Parkwood Hospital; Geriatric Medicine
London, Ontario, Canada
Centre for Memory and Aging
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael'S Hospital
Toronto, Ontario, Canada
Baycrest Health Sciences
Toronto, Ontario, Canada
Devonshire Clinical Research
Woodstock, Ontario, Canada
Center for Diagnosis and Research on Alzheimer's disease
Greenfield Park, Quebec, Canada
Q & T Research Sherbrooke
Sherbrooke, Quebec, Canada
Alpha Recherche Clinique
Québec, , Canada
China-Japan Friendship Hospital
Beijing, , China
Beijing Anding Hospital, Capital Medical University
Beijing, , China
Beijing Tian Tan Hospital,Capital Medical University
Beijing, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Sun Yat-sen Memorial Hospital; Neurology
Guangzhou, , China
Guangdong Provincial People's Hospital; Breast
Guangzhou, , China
Guangzhou First Municipal People's Hospital
Guangzhou, , China
The Second Affiliated Hospital, Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
The Second Affiliated Hospital to Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Zhongda Hospital Affiliated to Southeast University
Nanjing, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai Mental Health Center
Shanghai, , China
Huashan Hospital Affiliated to Fudan University
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
Shenzhen, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, , China
Northern Jangsu People's Hospital
Yangzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
CHU Amiens Hopital Sud; Neurologie
Amiens Cedex1, , France
Hôpital Avicenne; Centre de Recherche Clinique
Bobigny, , France
Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
Bron, , France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, , France
Hôpital Lariboisière
Paris, , France
CHU Poitiers - Hopital La Miletrie
Poitiers, , France
CHU Strasbourg Hôpital Hautepierre
Strasbourg, , France
Gerontopole; Centre de Recherche clinique
Toulouse, , France
Hopital des Charpennes
Villeurbanne, , France
Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin
Berlin, , Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, , Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, , Germany
Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
Cologne, , Germany
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Leipzig, , Germany
Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
Mainz, , Germany
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, , Germany
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster, , 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
Semmelweis University; Department of Neurology
Budapest, , Hungary
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
Modena, Emilia-Romagna, Italy
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
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 Ospedale San Raffaele; Centro Disturbi della Memoria
Milan, Lombardy, Italy
ASST DI MONZA; Neurologia
Monza, 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
Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Medical Corporation Hakuyokai Kashiwado Hospital
Chiba, , Japan
Inage Neurology and Memory Clinic
Chiba, , Japan
Juntendo University Urayasu Hospital
Chiba, , Japan
Southern Tohoku Medical Clinic
Fukushima, , Japan
Yuai Clinic
Kanagawa, , Japan
Shonan Kamakura General Hospital
Kanagawa, , Japan
Mishima Hospital
Niigata, , Japan
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, , Japan
Shizuoka City Shimizu Hospital
Shizuoka, , Japan
Jichiidai Station Brain Clinic
Tochigi, , Japan
Yotsuya Medical Cube
Tokyo, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo, , Japan
Nozomi Memory Clinic
Tokyo, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
P-One Clinic
Tokyo, , Japan
Yamagata Tokusyukai Hospital
Yamagata, , Japan
Vilnius University Hospital Santariskiu Clinics; Neurology
Vilnius, , Lithuania
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista, , Peru
Clinica Internacional; Unidad De Investigacion
Lima, , Peru
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Lima, , Peru
Hospital Nacional Cayetano Heredia; Servicio de Neurologia
San Martín de Porres, , Peru
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Krasnoyarsk Krai, Russia
University ?linic of headaches
Moscow, Moscow Oblast, Russia
City Clin Hosp n.a. S.P.Botkin
Moscow, Moscow Oblast, Russia
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva, Moscow Oblast, Russia
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
Saint Petersburg, Sankt-Peterburg, Russia
Vertebronevrologiya LLC
Kazan', Tatarstan Republic, Russia
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan', Tatarstan Republic, Russia
City Clinical Hospital # 2 n.a. V.I. Razumovsky
Saratov, , Russia
Nebbiolo Center for Clinical Trials
Tomsk, , Russia
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
Santander, Cantabria, Spain
Hospital San Pedro; Servicio de Neurología
Logroño, La Rioja, Spain
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
Móstoles, Madrid, Spain
Hospital General Universitario de Albacete; Servicio de Neurología
Albacete, , Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona, , Spain
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, , Spain
Hospital Universitario Reina Sofia; Servicio de Neurologia
Córdoba, , Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, , Spain
Hospital Ruber Internacional; Servicio de Neurología
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
Salamanca, , Spain
Hospital Virgen del Rocío; Servicio de Neurología
Seville, , Spain
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia, , Spain
Servicio de Neurología Hospital Viamed Montecanal.
Zaragoza, , Spain
Changhua Christian Hospital; Neurology
Changhua County, , Taiwan
Kaohsiung Medical University Hospital; Neurology
Kaohsiung City, , Taiwan
Chang Gung Memorial Foundation - Kaohsiung - Neurology
Niaosong Dist., , Taiwan
China Medical University Hospital; Neurology
North Dist., , Taiwan
National Taiwan University Hospital; Neurology
Taipei, , Taiwan
Chang Gung Memorial Foundation - Linkou - Neurology
Taoyuan District, , Taiwan
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.
Asada T, Thanasopoulou A, Delmar P, Wojtowicz J, Smith J, Yoshiyama Y, Yokoi K, Watanabe C, Isozaki M, Ozaki R, Ishida T, Tatsuda H, Tamaoka A. Japanese participant data from three gantenerumab trials in early Alzheimer's disease. Alzheimers Dement. 2025 Apr;21(4):e70192. doi: 10.1002/alz.70192.
Bittner T, Tonietto M, Klein G, Belusov A, Illiano V, Voyle N, Delmar P, Scelsi MA, Gobbi S, Silvestri E, Barakovic M, Napolitano A, Galli C, Abaei M, Blennow K, Barkhof F. Biomarker treatment effects in two phase 3 trials of gantenerumab. Alzheimers Dement. 2025 Feb;21(2):e14414. doi: 10.1002/alz.14414. Epub 2025 Jan 30.
Salloway S, Wojtowicz J, Voyle N, Lane CA, Klein G, Lyons M, Rossomanno S, Mazzo F, Bullain S, Barkhof F, Bittner T, Schneider A, Grundman M, Aldea R, Boada M, Smith J, Doody R. Amyloid-Related Imaging Abnormalities (ARIA) in Clinical Trials of Gantenerumab in Early Alzheimer Disease. JAMA Neurol. 2025 Jan 1;82(1):19-29. doi: 10.1001/jamaneurol.2024.3937.
Bateman RJ, Smith J, Donohue MC, Delmar P, Abbas R, Salloway S, Wojtowicz J, Blennow K, Bittner T, Black SE, Klein G, Boada M, Grimmer T, Tamaoka A, Perry RJ, Turner RS, Watson D, Woodward M, Thanasopoulou A, Lane C, Baudler M, Fox NC, Cummings JL, Fontoura P, Doody RS; GRADUATE I and II Investigators and the Gantenerumab Study Group. Two Phase 3 Trials of Gantenerumab in Early Alzheimer's Disease. N Engl J Med. 2023 Nov 16;389(20):1862-1876. doi: 10.1056/NEJMoa2304430.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001364-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WN29922
Identifier Type: -
Identifier Source: org_study_id
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