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A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224106
First Posted: October 19, 2010
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks, with an option for an additional 2 years of treatment.

Condition Intervention Phase
Alzheimer's Disease Drug: Gantenerumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease and Up to Three Years of an Open-Label Extension With Active Study Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 [ Time Frame: Baseline, Week 104 ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog-11) Scores at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Time to Onset of Dementia [ Time Frame: Every 6 months to up to 3 years (1096 days) ]
  • Mean Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Composite Score at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Mean Change from Baseline in Free and Cued Selective Reminding Test (FCSRT) Score at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Mean Change From Baseline in Functional Activities Questionnaire (FAQ) Score at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Mean Change From Baseline in CDR-Global Score at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Mean Change from Baseline in Neuropsychiatric Inventory (NPI) Questionnaire Score at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Percent Change from Baseline in Cerebrospinal Fluid Biomarkers (Phosphorylated-tau [p-tau], Amyloid Beta 1-42 [Abeta 1-42], Total tau [t-tau]) at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Percent Change from Baseline in Hippocampal Volume at Week 104 [ Time Frame: Baseline, Week 104 ]
  • Percent Change From Baseline in Cortical Composite Sustained Uptake Volume Ratio (SUVr) in Different Brain Regions at Week 156 [ Time Frame: Baseline, Week 156 ]
  • Gantenerumab Plasma Concentration at Different Time Points [ Time Frame: Prior to injections at Weeks 1, 8, 20, 44, 53, 68, 100, 101 ]
  • Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 104 [ Time Frame: Baseline, Week 104 ]

Enrollment: 799
Study Start Date: November 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gantenerumab 105 mg (Parts 1 and 2)
Participants with Alzheimer's disease will receive gantenerumab 105 milligrams (mg) by SC injection every 4 weeks (q4w) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who complete the Week 104 visit will be given an option to continue the treatment received during Part 1 for 2 additional years in Part 2.
Drug: Gantenerumab
Participants will receive gantenerumab 105 or 225 mg SC injection q4w.
Experimental: Gantenerumab 225 mg (Parts 1 and 2)
Participants with Alzheimer's disease will receive gantenerumab 225 mg by SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who complete the Week 104 visit will be given an option to continue the treatment received during Part 1 for 2 additional years in Part 2.
Drug: Gantenerumab
Participants will receive gantenerumab 105 or 225 mg SC injection q4w.
Placebo Comparator: Placebo (Parts 1 and 2)
Participants with Alzheimer's disease will receive placebo SC injection q4w for 104 weeks or approximately 2 years during Part 1 of the study. Participants who complete the Week 104 visit will be given an option to continue the treatment received during Part 1 for 2 additional years in Part 2.
Drug: Placebo
Participants will receive placebo SC injection q4w.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants, 50-85 years of age
  • Participants with prodromal Alzheimer's disease who are not receiving memantine or cholinesterase inhibitors
  • Has a study partner who in the investigator's judgement has frequent and sufficient contact with the participant as to be able to provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
  • Has had sufficient education or work experience to exclude mental retardation
  • Study partner has noticed a recent gradual decrease in participant's memory (over the last 12 months), which the participant may or may not be aware of
  • Screening Mini Mental State Exam (MMSE) score of 24 or above

Additional inclusion criteria for sub study:

  • Able and willing to travel to PET imaging center and complete the planned scanning sessions
  • Past and planned exposure to ionizing radiation not exceeding safe and permissible levels

Exclusion Criteria:

  • Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
  • A history of stroke
  • A documented history of transient ischemic attack within the last 12 months
  • History of schizophrenia, schizoaffective or bipolar disorder
  • Currently meets criteria for major depression
  • Within the last 2 years, unstable or clinical significant cardiovascular disease (myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

  • Inclusion in a research and/or medical protocol involving PET ligands or other radioactive agents within 12 months
  • Present or planned participation in a research and/or medical protocol involving PET ligands or radioactive agents other than study WN25203
  • Have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224106


  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85020
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Pacific Neuroscience Med Grp
Oxnard, California, United States, 93030
United States, Connecticut
Yale University ADRU
New Haven, Connecticut, United States, 06510
United States, Florida
Brain Matters Research, Inc.
Delray Beach, Florida, United States, 33445
Infinity Clinical Research
Hollywood, Florida, United States, 33021
Compass Research
Orlando, Florida, United States, 32806
Roskamp Institute, Inc.
Sarasota, Florida, United States, 34243
Compass Research
The Villages, Florida, United States, 32162
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta Center For Medical Research
Atlanta, Georgia, United States, 30308
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston Center for Memory
Newton, Massachusetts, United States, 02459
United States, Michigan
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
Kalamazoo, Michigan, United States, 49008
United States, Mississippi
Neurological Research Center
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
CRI Lifetree Marlton
Marlton, New Jersey, United States, 08053
Princeton Medical Institute
Princeton, New Jersey, United States, 08540
United States, New York
Nathan Kline Institute
Orangeburg, New York, United States, 10962
University of Rochester Medical Center; Monroe Community Hospital
Rochester, New York, United States, 14627
United States, North Carolina
Alzheimer's Memory Center
Charlotte, North Carolina, United States, 28270
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607-6520
United States, Oregon
Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Northeastern Pennsylvania Memory
Plains, Pennsylvania, United States, 18705
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Texas Neurology PA
Dallas, Texas, United States, 75214
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
United States, Vermont
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, United States, 05201
Argentina
Hospital Italiano
Buenos Aires, Argentina, C1181ACH
IME - Instituto Médico Especializado; Ensayos Clínicos
Buenos Aires, Argentina, C1405BCH
ALPI-Inst. de Rehabilitacion Marcelo Fitte
Buenos Aires, Argentina, C1425BWO
CEMIC
Buenos Aires, Argentina, C1431FWO
Mulieris
Caba, Argentina, C1022AAO
Instituto De Neurología Cognitiva - INECO
Caba, Argentina, C1126AAB
FLENI
Caba, Argentina, C1428AQK
Instituto Kremer
Córdoba, Argentina, X5004AOA
CENPIA; Neurología - Psicología
La Plata, Argentina, B1902AJU
Australia, New South Wales
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
Hornsby, New South Wales, Australia, 2077
Prince of Wales Hospital, Academic Department for Old Age Psychiatry
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Royal Adelaide Hospital; Memory Trials Centre
Adelaide, South Australia, Australia, 5000
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, Australia, 5011
Australia, Victoria
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
The McCusker Alzheimer's Research Founation
Nedlands, Western Australia, Australia, 6009
Belgium
UZ Antwerpen
Edegem, Belgium, 2650
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Brazil
Hospital das Clinicas - UFPR; Ciencias da Saude
Curitiba, PR, Brazil, 80060-900
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Hospital Mae de Deus
Porto Alegre, RS, Brazil, 90110-270
Universidade Federal de Sao Paulo - UNIFESP; Neurologia
Sao Paulo, SP, Brazil, 04024-002
Hospital das Clinicas - FMUSP; Psiquiatria
Sao Paulo, SP, Brazil, 05403-010
Canada, Nova Scotia
True North Clinical Research Kentville
Kentville,, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H 2P4
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada, M3B 2S7
The Centre for Memory and Aging
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
NeuroSearch Developpements inc
Greenfield Park, Quebec, Canada, J4V 2J2
McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric
Montreal, Quebec, Canada, H3T 1E2
CHAUQ - Hôpital Enfant-Jésus
Quebec City, Quebec, Canada, G1J 1Z4
Diex Recherche Sherbrooke
Sherbrooke, Quebec, Canada, J1H 1Z1
Chile
Biomedica Research Group
Santiago, Chile, 7500710
Especialidades Medicas LYS
Santiago, Chile, 7560356
CIMN Centro de Investigaciones Medicas Neurologicas
Viña de Mar, Chile, 2520997
Czech Republic
St. Anne´s University Hospital; Clinical Trials Department
Brno, Czech Republic, 656 91
Fakultní Nemocnice Olomouc; Neurologicka Klinika
Olomouc, Czech Republic, 77521
Vestra Clinics s.r.o.
Rychnov nad Kneznou, Czech Republic, 516 01
Denmark
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
Aarhus C, Denmark, 8000
Rigshospitalet, Hukommelsesklinikken 6911
Copenhagen, Denmark, 2100
Finland
Turku Hospital; PET (Positron Emission Tomography) Center
Turku, Finland, 20520
France
Hopital Avicenne; Neurologie
Bobigny, France, 93009
Hopital Pellegrin; Cmrr Aquitaine
Bordeaux, France, 33076
Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie
Bron, France, 69677
CHU De Caen; Service De Neurologie Dejerine
Caen, France, 14033
Hopital B Roger Salengro; Cmrr Lille
Lille, France, 59037
Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
Paris, France, 75651
CHU de Rouen Hopital; Service de Neurologie
Rouen, France, 76031
Hop Guillaume Et Rene Laennec; Cmrr St Herblain
St Herblain, France, 44800
Hopital Hautepierre; Centre dInvestigation Clinique
Strasbourg, France, 67098
Hopital de La Grave
Toulouse, France, 31059
Germany
Univ Berlin; Klin fur Psychi & Psycho Charite
Berlin, Germany, 12203
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
Bonn, Germany, 53127
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
Frankfurt, Germany, 60528
AFL Arzneimittelforschung Leipzig GmbH
Leipzig, Germany, 04107
Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie
Mannheim, Germany, 68159
Pharmakologisches Studienzentrum
Mittweida, Germany, 09648
Neurologische Praxis Dr. Andrej Pauls
München, Germany, 80331
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, Germany, 81675
Office of Dr Klaus Steinwachs Neurology & Psychiatry
Nürnberg, Germany, 90402
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
Rostock, Germany, 18147
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, Germany, 89081
Israel
Rambam Medical Center
Haifa, Israel, 31096
Sheba Medical Center; Psychiatry Department
Ramat Gan, Israel, 5262100
Italy
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze
Modena, Emilia-Romagna, Italy, 41126
Universita' Di Parma Istituto Neurologia
Parma, Emilia-Romagna, Italy, 43126
Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
Brescia, Lombardia, Italy, 25100
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
Brescia, Lombardia, Italy, 25125
Irccs Multimedica Santa Maria; Unita' Di Neurologia
Castellanza, Lombardia, Italy, 21053
Irccs Ospedale Maggiore Policlinico Di Milano; Scienze Neurologiche
Milano, Lombardia, Italy, 20122
Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
Milano, Lombardia, Italy, 20132
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Torrette - Ancona, Marche, Italy, 60100
Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1
Firenze, Toscana, Italy, 50134
Azienda Ospedaliera Universitaria Integrata; Neuroscienze Centro Alzheimer e Disturbi Cognitivi
Verona, Veneto, Italy, 37126
Korea, Republic of
Seoul National University Bundang Hospital; Neurology Department
Gyeonggi-do, Korea, Republic of, 463-707
Konkuk University Medical Center
Seoul, Korea, Republic of, 05030
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Seoul St Mary's Hospital
Seoul, Korea, Republic of, 06591
Asan Medical Center.
Seoul, Korea, Republic of, 138-736
Mexico
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Culiacan, Mexico, 80020
Hospital Mexico Americano
Guadalajara, Mexico, 44610
Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia
Guadalajara, Mexico, 44620
INCIDE
Mexico City, Mexico, 11000
Hospital Uni; Dr. Jose E. Gonzalez
Monterrey, Mexico, 64460
Centro Medico San Francisco; Geriatrics
Monterrey, Mexico, 64710
Hospital Universitario de Saltillo
Saltillo, Mexico, 25000
Netherlands
Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie
'S Hertogenbosch, Netherlands, 5223 GZ
Alzheimer Research Center
Amsterdam, Netherlands, 1081 GM
Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Poland, 15-732
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy Klinika Psychiatrii
Bydgoszcz, Poland, 85-094
PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
Bydgoszcz, Poland, 85-796
NEURO - KARD Ośrodek Badań Klinicznych
Poznań, Poland, 61-853
Przychodnia Specjalistyczna PROSEN
Warszawa, Poland, 01-231
mMED Maciej Czarnecki
Warszawa, Poland, 01-697
Portugal
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Amadora, Portugal, 2720-276
Hospital de Santa Maria; Servico de Neurologia
Lisboa, Portugal, 1649-035
Russian Federation
Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital
Ekaterinburg, Russian Federation, 620036
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan, Russian Federation, 420101
Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
Saint Petersburg, Russian Federation, 190103
City Clinical Hospital # 2 n.a. V.I. Razumovsky
Saratov, Russian Federation, 410028
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
St. Petersburg, Russian Federation, 194044
Spain
Fundació ACE
BArcelon, Barcelona, Spain, 08034
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrasa, Barcelona, Spain, 08221
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, Spain, 48903
Hospital del Mar; Servicio de Neurologia
Barcelona, Spain, 08003
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, Spain, 08025
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, Spain, 08036
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, Spain, 28034
Hospital Clinico Universitario San Carlos; Servicio de Geriatria
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Neurologia
Madrid, Spain, 28046
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia, Spain, 46017
Sweden
Skånes Universitetssjukhus Malmö, Minneskliniken
Malmoe, Sweden, SE-20502
Switzerland
Universitäres Zentrum für Altersmedizin und Rehabilitation
Basel, Switzerland, 4055
HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique
Chêne-Bourg, Switzerland, 1225
Turkey
Akdeniz University School of Medicine, Neurology Department
Antalya, Turkey, 07058
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, Turkey, 34093
Ondokuz Mayis University School of Medicine; Neurology
Samsun, Turkey, 55139
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
Cardiff, United Kingdom, CF64 2XX
St Margaret's Hospital
Epping, United Kingdom, CM16 6TN
Glasgow Memory Clinic
Glasgow, United Kingdom, G20 0XA
Charing Cross Hospital; Dept of Neurosciences
London, United Kingdom, W6 8RF
Campus for Ageing & Vitality; Clincal Ageing Research Unit
Newcastle, United Kingdom, NE4 5PL
John Radcliffe Hospital; Nuffield dept. Of medicine
Oxford, United Kingdom, OX3 9DU
Moorgreen Hospital; Memory Assessment & Rsch Ctr
Southampton, United Kingdom, SO30 3JB
Victoria Centre; Kingshill Research Centre
Swindon, United Kingdom, SN3 6BW
Hollins Park Hospital
Warrington, United Kingdom, WA2 8WA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01224106     History of Changes
Other Study ID Numbers: WN25203
2010-019895-66 ( EudraCT Number )
First Submitted: October 14, 2010
First Posted: October 19, 2010
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs


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