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).
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
2 other identifiers
interventional
975
19 countries
155
Brief Summary
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
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 Aug 2018
Typical duration for phase_3 alzheimer-disease
155 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
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedStudy Start
First participant enrolled
August 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2022
CompletedResults Posted
Study results publicly available
January 17, 2024
CompletedJanuary 17, 2024
December 1, 2023
4.1 years
February 19, 2018
September 22, 2023
December 22, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement.
Baseline, Week 116
OLE Period: Number of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& 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 Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)
OLE Period : Number of Participants With 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.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)
OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (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.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)
OLE Period: Number of Participants With Injection-Site Reactions
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of 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.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)
Secondary Outcomes (20)
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score
Baseline, Week 116
- +15 more secondary outcomes
Other Outcomes (1)
Plasma Concentration of Gantenerumab
Pre-dose on Days 1, Weeks 24, 52 and 76; Post-dose on Day 4, Weeks 41, 103, and 115
Study Arms (2)
Gantenerumab
EXPERIMENTALGantenerumab will be administered as SC injections with gradual uptitration.
Placebo
PLACEBO COMPARATORPlacebo will be administered as SC injections with gradual uptitration.
Interventions
Gantenerumab will be administered as per the schedule specified in the respective arm.
Placebo matching to gantenerumab will be administered as per the schedule specified in the respective arm.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- Any evidence of a condition other than AD that may affect cognition
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (155)
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
Southern California Research LLC
Simi Valley, California, 93065, United States
Yale University School Of Medicine
New Haven, Connecticut, 06519, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Accel Research Sites - CRU Tampa
Bradenton, Florida, 34201, 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
Progressive Medical Research
Port Orange, Florida, 32127, 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
Emory University
Atlanta, Georgia, 30329, United States
Rush Alzheimer's Disease Cntr.
Chicago, Illinois, 60612, United States
American Health Network Institute, LLC
Avon, Indiana, 46123, United States
Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
Boston, Massachusetts, 02115, United States
ActivMed Practices and Research
Haverhill, Massachusetts, 01830, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, 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
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
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718, United States
Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute
Cleveland, Ohio, 44195, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Summit Research Network Inc.
Portland, Oregon, 97210, United States
Texas Neurology PA
Dallas, Texas, 75206, United States
Kerwin Medical Center
Dallas, Texas, 75231, 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
Hospital Italiano
Buenos Aires, C1181ACH, 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
Fundacion Scherbovsky
Mendoza, M5500AYB, Argentina
AZ Sint Blasius (Dendermonde)
Dendermonde, 9200, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
Psicomed Estudios Médicos
Antofagasta, 1270244, Chile
Biomedica Research Group
Santiago, 7500710, Chile
Especialidades Medicas LYS
Santiago, 7560356, Chile
Clinical Hospital Centre Zagreb;Clinic for Neurology
Zagreb, 10000, Croatia
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
University of Eastern Finland
Kuopio, 70210, Finland
Yachiyo Hospital
Aichi, 446-8510, Japan
Nagoya Ekisaikai Hospital
Aichi, 454-8502, Japan
National Center for Geriatrics and Gerontology
Aichi, 474-8511, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, 739-0696, 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
Rakuwakai Otowa Hospital
Kyoto, 607-8062, Japan
Uji Takeda Hospital
Kyoto, 611-0021, Japan
Rijikai Medical Corporation Katayama Medical Clinic
Okayama, 710-0813, Japan
Kishiwada Tokushukai Hospital
Osaka, 596-0042, Japan
National Hospital Organization Hizen Psychiatric Medical Center
Saga, 842-0192, Japan
Medical corporation Ichiekai Itsuki Hospital
Tokushima, 770-0852, Japan
Tokushima Hospital
Tokushima, 776-8585, Japan
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 Culiacan; Neurociencias
Culiacán, Sinaloa, 80020, Mexico
Brain Research Center B.V
Amsterdam, 1081 GN, Netherlands
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
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
Plewiska, 62-064, Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice ?l?skie, 41-100, Poland
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Sopot, 81-855, Poland
mMED Maciej Czarnecki
Warsaw, 01-684, Poland
Pratia S.A.
Warsaw, 01-868, Poland
NZOZ WCA
Wroc?aw, 53-659, Poland
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Amadora, 2720-276, Portugal
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
National University Hospital (NUH); Neuroscience
Singapore, 117549, Singapore
National Neuroscience Institute; Neurology
Singapore, 308433, Singapore
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
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Hospital General Universitario de Elche; Servicio de Neurología
Elche, Alicante, 03203, Spain
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrassa, Barcelona, 08222, Spain
Hospital Virgen del Puerto. Servicio de Neurología
Plasencia, Caceres, 10600, Spain
Policlínica Guipuzcoa; Servicio de Neurología
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital Universitario de Santa Maria; Servicio de Neurología
Lleida, Lerida, 25198, 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 del Mar; Servicio de Neurologia
Barcelona, 08003, Spain
Fundación ACE; Servicio de Neurología
Barcelona, 08028, Spain
Universitario de La Princesa; Servicio de Neurología
Madrid, 28006, Spain
Hospital Victoria Eugenia; Servico Neurología
Seville, Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, 46026, Spain
Complejo Asistencial de Zamora; Servicio Psiquiatria
Zamora, 49021, 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
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, 34093, Turkey (Türkiye)
Bezmialem Vakif Univ Medical
Istanbul, 34286, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, 55139, Turkey (Türkiye)
Royal Cornhill Hospital; OAP Directorate
Aberdeen, AB25 2ZH, United Kingdom
The Rice Centre; Royal United Hospital
Bath, BA1 3NG, United Kingdom
Re-Cognition
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; Brain Science Research Unit
Chertsey, KT16 9AU, United Kingdom
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
Crowborough, TN6 1HB, United Kingdom
Ninewells Hospital
Dundee, DD12 9SY, United Kingdom
Queen Elizabeth University Hospital; Clinical Research Facility
Glasgow, G51 4TF, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
RE:Cognition Health
London, W1G 9RU, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Campus for Ageing and Vitality
Newcastle, NE4 5PL, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, 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 (5)
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.
PMID: 40603145DERIVEDAsada 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.
PMID: 40302041DERIVEDBittner 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.
PMID: 39887500DERIVEDSalloway 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: 39556389DERIVEDBateman 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.
PMID: 37966285DERIVED
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2018
First Posted
February 23, 2018
Study Start
August 22, 2018
Primary Completion
September 23, 2022
Study Completion
November 28, 2022
Last Updated
January 17, 2024
Results First Posted
January 17, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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).