A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease (Scarlet Road)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- Banner Alzheimer's Institute
- University of California, San Diego
- Yale University ADRU
- Brain Matters Research, Inc.
- Infinity Clinical Research
- Accelerated Enrollment Solutions
- Roskamp Institute, Inc.
- Compass Research
- Premiere Research Institute
- Indiana University
- Boston Center for Memory
- Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
- Neurological Research Center
- Princeton Medical Institute
- Nathan Kline Institute
- University of Rochester Medical Center; Monroe Community Hospital
- Alzheimer's Memory Center
- Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center
- Northeastern Pennsylvania Memory
- Rhode Island Mood & Memory Research Institute
- Butler Hospital
- Senior Adults Specialty Research
- Texas Neurology PA
- Clinical Neuroscience Research Associates, Inc.
- Hospital Italiano
- IME - Instituto Médico Especializado; Ensayos Clínicos
- ALPI-Inst. de Rehabilitacion Marcelo Fitte
- CEMIC
- Mulieris
- Instituto De Neurología Cognitiva - INECO
- FLENI
- Instituto Kremer
- CENPIA; Neurología - Psicología
- Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
- Prince of Wales Hospital, Academic Department for Old Age Psychiatry
- Royal Adelaide Hospital; Memory Trials Centre
- The Queen Elizabeth Hospital; Neurology
- Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
- Australian Alzheimer's Research Foundation
- UZ Leuven Gasthuisberg
- Hospital das Clinicas - UFPR; Ciencias da Saude
- Hospital das Clinicas - UFRGS
- Hospital Mae de Deus
- Hospital das Clinicas - FMUSP; Psiquiatria
- Universidade Federal de Sao Paulo - UNIFESPX; Neurologia
- True North Clinical Research
- Kawartha Centre - Redefining Healthy Aging
- Toronto Memory Program
- Centre for Memory and Aging
- NeuroSearch Developpements inc
- McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric
- CHAUQ - Hôpital Enfant-Jésus
- Biomedica Research Group
- Especialidades Medicas LYS
- St. Anne´s University Hospital; Clinical Trials Department
- Vestra Clinics s.r.o.
- Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
- Rigshospitalet, Hukommelsesklinikken
- CRST Oy
- Hopital Avicenne; Neurologie
- Hopital Pellegrin; Cmrr Aquitaine
- Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie
- CHU De Caen; Service De Neurologie Dejerine
- Hopital B Roger Salengro; Cmrr Lille
- Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
- CHU de Rouen Hopital; Service de Neurologie
- Hop Guillaume Et Rene Laennec; Cmrr St Herblain
- Hopital Hautepierre; Centre dInvestigation Clinique
- Hopital de La Grave
- Univ Berlin; Klin fur Psychi & Psycho Charite
- Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
- Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
- PANAKEIA - Arzneimittelforschung Leipzig GmbH
- Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie
- Pharmakologisches Studienzentrum
- Neurologische Praxis Dr. Andrej Pauls
- Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
- Office of Dr Klaus Steinwachs Neurology & Psychiatry
- Universitätsklinikum Rostock Zentrum für Nervenheilkunde
- Universitätsklinikum Ulm; Klinik für Neurologie
- Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze
- Universita' Di Parma Istituto Neurologia
- Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
- IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
- Irccs Multimedica Santa Maria; Unita' Di Neurologia
- Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
- Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1
- Seoul National University Bundang Hospital; Neurology Department
- Konkuk University Medical Center
- Samsung Medical Center
- Seoul St Mary's Hospital
- Asan Medical Center.
- Hospital Mexico Americano
- Hospital Universitario; Dr. Jose E. Gonzalez
- Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
- Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia
- Estimulacion Magnetica Trnscraneal de Mexico SC.
- Centro Medico San Francisco; Geriatrics
- Hospital Universitario de Saltillo
- Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie
- Brain Research Center B.V
- Podlaskie Centrum Psychogeriatrii
- PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER
- NEURO - KARD Ośrodek Badań Klinicznych
- Przychodnia Specjalistyczna PROSEN
- mMED Maciej Czarnecki
- Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
- Hospital de Santa Maria; Servico de Neurologia
- Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital
- State autonomous institution of healthcare Inter-regional clinical and diagnostic center
- Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
- City Clinical Hospital # 2 n.a. V.I. Razumovsky
- Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
- Fundació ACE
- Hospital Mutua De Terrasa; Servicio de Neurologia
- Hospital de Cruces; Servicio de Neurologia
- Hospital del Mar; Servicio de Neurologia
- Hospital Clinic i Provincial; Servicio de Neurologia
- Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
- Hospital Ramon y Cajal; Servicio de Neurologia
- Hospital Universitario 12 de Octubre; Servicio de Neurologia
- Hospital Universitario La Paz; Servicio de Neurologia
- Hospital Universitario Dr. Peset; Servicio de Neurologia
- Skånes Universitetssjukhus Malmö, Minneskliniken
- Felix Platter-Spital Medizin Geriatrie
- HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique
- Akdeniz University School of Medicine, Neurology Department
- Istanbul University Istanbul School of Medicine; Neurology
- Ondokuz Mayis University School of Medicine; Neurology
- Addenbrooke's Hospital
- Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
- St Margaret's Hospital
- Glasgow Memory Clinic
- Charing Cross Hospital; Dept of Neurosciences
- Campus for Ageing & Vitality; Clincal Ageing Research Unit
- Moorgreen Hospital; Memory Assessment & Rsch Ctr
- Victoria Centre; Kingshill Research Centre
- Hollins Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Placebo (Parts 1 and 2)
Gantenerumab 105 mg (Parts 1 and 2)
Gantenerumab 225 mg (Parts 1 and 2)
Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])
Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])
Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.