Study Stopped
Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease
2 other identifiers
interventional
1,382
29 countries
268
Brief Summary
This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Jan 2021
Shorter than P25 for phase_3 alzheimer-disease
268 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedStudy Start
First participant enrolled
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2023
CompletedResults Posted
Study results publicly available
May 8, 2024
CompletedMay 8, 2024
April 1, 2024
2.1 years
May 1, 2020
March 4, 2024
April 12, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. A SAE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug or a significant medical event in the investigator's judgment. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS= assesses lifetime suicidality of participant (at baseline) \& any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation (intensity of ideation, behavior, \& attempts with actual/potential lethality). Categories have yes/no responses, include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted/Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior= "yes" to any of listed categories. Score of 0= no suicide risk. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. First dosing visit in OLE (first dosing in current study or OLE period of parent GRADUATE studies)=baseline (OLE Day 1).
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With Injection-Site Reactions (ISRs)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, regardless of casual attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants Who Discontinued the Study Due an AE
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Adverse Event of Special Interest (AESI)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. AEs that were considered to be of special interest for this study included cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law and suspected transmission of an infectious agent by the study drug. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).
From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Secondary Outcomes (10)
Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS)
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB)
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score
Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
- +5 more secondary outcomes
Study Arms (2)
Group 1
EXPERIMENTALParticipants, who completed the double-blind part and did not enter the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the Week 116 visit of Study WN29922 or WN39658. This will be considered the OLE baseline visit (OLE Day 1).
Group 2
EXPERIMENTALParticipants, who completed the double-blind part and the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the OLE Week 34 visit or the final dose visit in the Study WN29922 or WN39658 OLE.
Interventions
Group 1 participants who were in the active arm in the double blind part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W. Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme before receiving target dose of open label gantenerumab, 510 mg SC, Q2W.
Eligibility Criteria
You may qualify if:
- Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
- The participant should be capable of completing assessments either alone or with the help of the caregiver
- Availability of a person (referred to as the "caregiver")
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of \<1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
- Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
You may not qualify if:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
- Prematurely discontinued from Study WN29922 or WN39658
- Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
- Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
- Evidence of disseminated leptomeningeal hemosiderosis
- Evidence of intracerebral macrohemorrhage
- Use of prohibited medication
- Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (268)
Banner Alzheimer?s Institute
Phoenix, Arizona, 85006, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Banner Sun Health Research Insitute
Sun City, Arizona, 85351, United States
Health Initiatives Research, PLLC
Fayetteville, Arkansas, 72703, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Irvine Center for Clinical Research
Irvine, California, 92614, United States
Desert Valley Research
Redlands, California, 92374, United States
Sutter Medical Group, Neurology
Sacramento, California, 95816, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403, United States
Southern California Research LLC
Simi Valley, California, 93065, United States
Yale University School Of Medicine
New Haven, Connecticut, 06519, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
JEM Research LLC
Atlantis, Florida, 33462, United States
Accel Research Sites - CRU Tampa
Bradenton, Florida, 34201, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
Brain Matters Research, Inc.
Delray Beach, Florida, 33445, United States
ClinCloud, LLC
Maitland, Florida, 32751, United States
Optimus U Corp
Miami, Florida, 33125, United States
Allied Biomedical Research Institute, Inc
Miami, Florida, 33155, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
Infinity Clinical Research, LLC
Sunrise, Florida, 33351, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Alzheimer?s Research and Treatment Center
Wellington, Florida, 33414, United States
Emory University
Atlanta, Georgia, 30329, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, 62702, United States
American Health Network Institute, LLC
Avon, Indiana, 46123, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46805, United States
Via Christi Research
Wichita, Kansas, 67214, United States
Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
Boston, Massachusetts, 02115, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Missouri Memory Center
Bolivar, Missouri, 65613, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center; Dept of Neurological Sciences
Omaha, Nebraska, 68198-8440, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, 89106, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755, United States
Neurological Associates of Long Island, PC
Lake Success, New York, 11042, United States
Columbia University Medical Center
New York, New York, 10032, United States
AD-CARE, University of Rochester Medical Center
Rochester, New York, 14620, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Behavioral Health Research
Charlotte, North Carolina, 28211, United States
Alzheimer's Memory Center
Matthews, North Carolina, 28105, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607-6520, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute
Cleveland, Ohio, 44195, United States
Ohio State University; College of Medicine
Columbus, Ohio, 43210, United States
Summit Research Network Inc.
Portland, Oregon, 97210, United States
Abington Neurological Associates
Abington, Pennsylvania, 19001, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Kerwin Medical Center
Dallas, Texas, 75231, United States
Neurology Consultants of Dallas; Research Department
Dallas, Texas, 75243, United States
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
University of Virginia
Charlottesville, Virginia, 22906, United States
Sentara Neurology Specialists
Norfolk, Virginia, 23507, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, 23294, United States
UW Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Hospital Italiano
CABA, C1199ABB, Argentina
Universidad Maimonides
Caba, C1405BCK, Argentina
Instituto Geriatrico Nuestra Señora de las Nieves
Capital Federal, C1427CCP, Argentina
Instituto Kremer
Córdoba, X5004AOA, Argentina
CEN Centro Especializado en Neurociencias
Córdoba, X5004FJF, Argentina
Instituto de Neurociencias San Agustín S.A.
La Plata, B1902AVF, Argentina
Fundación Scherbovsky; General Department
Mendoza, M5500AYB, Argentina
St Vincent's Hospital Sydney; Neurology
Darlinghurst, New South Wales, 2010, Australia
Central Coast Neurosciences Research
Erina, New South Wales, 2250, Australia
Southern Neurology
Kogarah, New South Wales, 2217, Australia
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, 5011, Australia
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, 3081, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, 6009, Australia
AZ Sint Blasius (Dendermonde)
Dendermonde, 9200, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
Curitiba, Paraná, 80810-040, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310, Brazil
Clinica Clinilive ltda
Maringá, Paraná, 87013-250, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital das Clinicas - FMUSP_X; Neurologia
São Paulo, São Paulo, 05403-000, Brazil
The Medical Arts Health Research Group - West Vancouver
Vancouver, British Columbia, V7T 2Z3, Canada
Parkwood Hospital; Geriatric Medicine
London, Ontario, N6C 5J1, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Baycrest Health Sciences
Toronto, Ontario, M6A 2E1, Canada
Devonshire Clinical Research
Woodstock, Ontario, N4S 5P5, Canada
Center for Diagnosis and Research on Alzheimer's disease
Greenfield Park, Quebec, J4V 2J2, Canada
Alpha Recherche Clinique
Québec, G3K 2P8, Canada
Psicomed Estudios Médicos
Antofagasta, 1270244, Chile
Biomedica Research Group
Santiago, 7500710, Chile
Especialidades Medicas LYS
Santiago, 7560356, Chile
Beijing Tian Tan Hospital,Capital Medical University
Beijing, 100071, China
Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken
Aarhus N, 8200, Denmark
Rigshospitalet, Hukommelsesklinikken
København Ø, 2100, Denmark
Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn
Svendborg, 5700, Denmark
Terveystalo Ruoholahti
Helsinki, 00180, Finland
Itä-Suomen yliopisto, Kuopion kampus
Kuopio, 70210, Finland
CHU Amiens Hopital Sud; Neurologie
Amiens Cedex1, 80054, France
Hôpital Avicenne; Centre de Recherche Clinique
Bobigny, 93009, France
Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
Bron, 69677, France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, 13005, France
Hôpital Lariboisière
Paris, 75010, France
CHU Poitiers - Hopital La Miletrie
Poitiers, 86000, France
CHU Strasbourg Hôpital Hautepierre
Strasbourg, 67098, France
Gerontopole; Centre de Recherche clinique
Toulouse, 31059, France
Hopital des Charpennes
Villeurbanne, 69100, France
Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin
Berlin, 12200, Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, 13125, Germany
Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
Cologne, 50937, Germany
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Leipzig, 04275, Germany
Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
Mainz, 55131, Germany
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, 81675, Germany
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster, 48149, Germany
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
Rostock, 18147, Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, 89081, Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede, 26655, Germany
Forschungszentrum Ruhr
Witten, 58455, Germany
Semmelweis University; Department of Neurology
Budapest, 1083, Hungary
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
Modena, Emilia-Romagna, 41126, Italy
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
Rome, Lazio, 00179, Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, 00185, Italy
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Rome, Lazio, 00186, Italy
IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
Brescia, Lombardy, 25125, Italy
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
Milan, Lombardy, 20132, Italy
ASST DI MONZA; Neurologia
Monza, Lombardy, 20900, Italy
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Pozzilli, Molise, 86077, Italy
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
Turin, Piedmont, 10126, Italy
Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, 90127, Italy
Yachiyo Hospital
Aichi, 446-8510, Japan
Nagoya Ekisaikai Hospital
Aichi, 454-8502, Japan
National Center for Geriatrics and Gerontology
Aichi, 474-8511, Japan
Medical Corporation Hakuyokai Kashiwado Hospital
Chiba, 260-8656, Japan
Tokyo Bay Advanced Medical and Makuhari Clinic
Chiba, 261-0024, Japan
Inage Neurology and Memory Clinic
Chiba, 263-0043, Japan
Juntendo University Urayasu Hospital
Chiba, 279-0021, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Southern Tohoku Medical Clinic
Fukushima, 963-8052, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, 739-0696, Japan
Kobe University Hospital
Hyōgo, 650-0017, Japan
Hyogo Prefectural HarimaHimeji General Medical Center
Hyōgo, 670-8560, Japan
Tsukazaki Hospital
Hyōgo, 671-1227, Japan
Matsui Dietary and Dementia Clinic
Hyōgo, 673-0891, Japan
Kagawa Prefectural Central Hospital
Kagawa, 760-8557, Japan
Shonan Kamakura General Hospital
Kanagawa, 247-8533, Japan
Rakuwakai Otowa Hospital
Kyoto, 607-8062, Japan
Uji Takeda Hospital
Kyoto, 611-0021, Japan
Okayama Kyokuto Hospital
Okayama, 703-8265, Japan
Rijikai Medical Corporation Katayama Medical Clinic
Okayama, 710-0813, Japan
MI Clinic
Osaka, 560-0004, Japan
Kishiwada Tokushukai Hospital
Osaka, 596-0042, Japan
National Hospital Organization Hizen Psychiatric Medical Center
Saga, 842-0192, Japan
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, 420-8688, Japan
Shizuoka City Shimizu Hospital
Shizuoka, 424-0911, Japan
Jichiidai Station Brain Clinic
Tochigi, 329-0403, Japan
Medical corporation Ichiekai Itsuki Hospital
Tokushima, 770-0852, Japan
Tokushima Hospital
Tokushima, 776-8585, Japan
Tokyo Medical and Dental University Hospital
Tokyo, 113-8519, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Nozomi Memory Clinic
Tokyo, 181-0013, Japan
National Center of Neurology and Psychiatry
Tokyo, 187-8551, Japan
P-One Clinic
Tokyo, 192-0071, Japan
Yamagata Tokusyukai Hospital
Yamagata, 990-0834, Japan
Vilnius University Hospital Santariskiu Clinics; Neurology
Vilnius, 08661, Lithuania
Mexico Centre for Clinical Research
Mexico City, Mexico CITY (federal District), 03100, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta
Monterrey, Nuevo León, 64460, Mexico
AVIX Investigación Clínica S.C
Monterrey, Nuevo León, 64710, Mexico
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Culiacán, Sinaloa, 80020, Mexico
Brain Research Center B.V
Amsterdam, 1081 GN, Netherlands
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista, Callao 2, Peru
Clinica Internacional; Unidad De Investigacion
Lima, 15001, Peru
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Lima, 15003, Peru
O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
?cinawa, 59-330, Poland
Podlaskie Centrum Psychogeriatrii
Bia?ystok, 15-756, Poland
NZOZ Vitamed
Bydgoszcz, 85-079, Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Katowice, 40-749, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
Plewiska, 62-064, Poland
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Sopot, 81-855, Poland
mMED Maciej Czarnecki
Warsaw, 01-684, Poland
Pratia S.A.
Warsaw, 02-171, Poland
NZOZ WCA
Wroc?aw, 53-659, Poland
Hospital de Braga; Servico de Neurologia
Braga, 4710-243, Portugal
HUC; Servico de Neurologia
Coimbra, 3000-075, Portugal
Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia
Guimarães, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, 4099-001, Portugal
Santa Cruz Behavioral PSC
Bayamón, 00961, Puerto Rico
University of Puerto Rico - Medical Science Campus; Internal Medicine
San Juan, 00936, Puerto Rico
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia
University ?linic of headaches
Moscow, Moscow Oblast, 121467, Russia
City Clin Hosp n.a. S.P.Botkin
Moscow, Moscow Oblast, 125101, Russia
City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow
Moskva, Moscow Oblast, 117556, Russia
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
Saint Petersburg, Sankt-Peterburg, 194044, Russia
Vertebronevrologiya LLC
Kazan', Tatarstan Republic, 420047, Russia
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan', Tatarstan Republic, 420101, Russia
MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric
Saratov, 410028, Russia
Nebbiolo Center for Clinical Trials
Tomsk, 634009, Russia
Dong-A University Hospital
Busan, 49201, South Korea
Myongji Hospital
Gyeonggi-do, 10475, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St Mary's Hospital
Seoul, 06591, South Korea
Ewha Womans University Hospital (Seoul)
Seoul, 07804, South Korea
Hospital General Universitario de Elche; Servicio de Neurología
Elche, Alicante, 03203, Spain
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Vallès, Barcelona, 8195, Spain
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrassa, Barcelona, 08222, Spain
Hospital Virgen del Puerto. Servicio de Neurología
Plasencia, Caceres, 10600, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
Santander, Cantabria, 39011, Spain
Policlínica Guipuzcoa; Servicio de Neurología
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital San Pedro; Servicio de Neurología
Logroño, La Rioja, 26006, Spain
Hospital Universitario de Santa Maria; Servicio de Neurología
Lleida, Lerida, 25198, Spain
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
Móstoles, Madrid, 28938, Spain
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcón, Madrid, 28223, Spain
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarre, 31008, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
CAE OROITU; Servicio de Neurología
Getxo, Vizcaya, 48993, Spain
Hospital General Universitario de Albacete; Servicio de Neurología
Albacete, Spain
Hospital del Mar; Servicio de Neurologia
Barcelona, 08003, Spain
Fundación ACE; Servicio de Neurología
Barcelona, 08028, Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona, 08035, Spain
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia; Servicio de Neurologia
Córdoba, 14004, Spain
Universitario de La Princesa; Servicio de Neurología
Madrid, 28006, Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, 28034, Spain
Hospital Ruber Internacional; Servicio de Neurología
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, 28041, Spain
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
Salamanca, 37005, Spain
Hospital Virgen del Rocío; Servicio de Neurología
Seville, 41013, Spain
Hospital Victoria Eugenia; Servico Neurología
Seville, Spain
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia, 46017, Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, 46026, Spain
Complejo Asistencial de Zamora; Servicio Psiquiatria
Zamora, 49021, Spain
Servicio de Neurología Hospital Viamed Montecanal.
Zaragoza, 50012, Spain
Skånes Universitetssjukhus Malmö, Minneskliniken
Malmo, 211 46, Sweden
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
Mölndal, 431 41, Sweden
KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
Stockholm, 141 86, Sweden
Changhua Christian Hospital; Neurology
Changhua County, 500, Taiwan
Kaohsiung Medical University Hospital; Neurology
Kaohsiung City, 807, Taiwan
Chang Gung Memorial Foundation - Kaohsiung - Neurology
Niaosong Dist., 83301, Taiwan
China Medical University Hospital; Neurology
North Dist., 40447, Taiwan
National Taiwan University Hospital; Neurology
Taipei, 100, Taiwan
Chang Gung Memorial Foundation - Linkou - Neurology
Taoyuan District, 333, Taiwan
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, 55139, Turkey (Türkiye)
The Rice Centre; Royal United Hospital
Bath, BA1 3NG, United Kingdom
Re:Cognition Health Birmingham
Birmingham, B16 8QQ, United Kingdom
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
Cheltenham, GL53 9DZ, United Kingdom
Surrey and Borders NHS Foundation Trust; Research and Development Department
Chertsey, KT16 9AU, United Kingdom
Ninewells Hospital
Dundee, DD12 9SY, United Kingdom
Queen Elizabeth University Hospital - PPDS
Glasgow, G51 4TF, United Kingdom
St George?s Hospital
London, SW17 ORE, United Kingdom
Re:Cognition Health London
London, W1G 9RU, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Campus for Ageing and Vitality
Newcastle, NE4 5PL, United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF, United Kingdom
University Southampton NHS Foundation Trust; Wessex Neurologica Centre
Southampton, SO166YD, United Kingdom
Related Publications (1)
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.
PMID: 39556389DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2020
First Posted
May 5, 2020
Study Start
January 26, 2021
Primary Completion
March 6, 2023
Study Completion
March 6, 2023
Last Updated
May 8, 2024
Results First Posted
May 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).