A Study of Gantenerumab in Participants With Mild Alzheimer Disease
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication
- Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology
- Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities
- Fluency in the language of the tests used at the study site
- Willingness and ability to complete all aspects of the study
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening
- Agreement not to participate in other research studies for the duration of this trial and its associated substudies
PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2
Exclusion Criteria:
- Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
- History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
- History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
- History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
- History of schizophrenia, schizoaffective disorder, or bipolar disorder
- Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)
- History or presence of atrial fibrillation
- Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
- Uncontrolled hypertension
- Chronic kidney disease
- Impaired hepatic function
PET imaging substudy, in addition to above:
- Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits
Part 2 Participants who have been discontinued from the study
Sites / Locations
- Banner Sun Health Research Insitute
- Territory Neurology and Research Institute
- ATP Clinical Research, Inc
- Pacific Research Network - PRN
- California Neuroscience Research Medical Group, Inc
- Meridien Research
- Brain Matters Research, Inc.
- Neuropsychiatric Research; Center of Southwest Florida
- Miami Jewish Health Systems; Clinical Research
- Accelerated Enrollment Solutions
- University of South Florida
- Alzheimer's Research and Treatment Center
- Indiana University
- Pennington Biomedical Research Center
- Louisiana Research Associates
- Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
- Millennium Psychiatric Associates, LLC
- Alzheimer's Research Corporation
- Ocean Rheumatology
- Nathan Kline Institute
- Richmond Behavioral Associates
- Alzheimer's Memory Center
- Richard H Weisler, MD
- Central States Research
- Abington Neurological Associates
- Northeastern Pennsylvania Memory
- Rhode Island Mood & Memory Research Institute
- Neurology Clinic PC
- Senior Adults Specialty Research
- University of Utah, Center for Alzheimer's Care Imaging & Research
- Instituto Neurologia Bs As
- Royal Adelaide Hospital; Memory Trials Centre
- The Queen Elizabeth Hospital; Neurology
- Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
- Australian Alzheimer's Research Foundation
- Cliniques Universitaires St-Luc
- UZ Leuven Gasthuisberg
- Shat Np Sveti Naum; 3Rd Clinic of Neurology
- MBAL St. Marina; First Neurology Department
- University of Calgary; Heritage Medical Research Clinic
- True North Clinical Research-Halifax
- True North Clinical Research
- Jbn Medical Diagnostic Services Inc.
- Parkwood Hospital; Geriatric Medicine
- Kawartha Centre - Redefining Healthy Aging
- Toronto Memory Program
- Sunnybrook Health Sciences Centre
- Recherches Neuro-Hippocame
- NeuroSearch Developpements inc
- Jewish General Hospital / McGill University
- Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus
- McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
- Alpha Recherche Clinique
- Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
- Rigshospitalet, Hukommelsesklinikken
- University of Eastern Finland
- CRST Oy
- Hopital Pellegrin; Cmrr Aquitaine
- Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie
- CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
- CHU de la Timone - Hopital d Adultes; Service de Neurologie
- CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie
- Hopital Hautepierre; Centre dInvestigation Clinique
- Hopital la Grave; Gerontopole - Centre de Recherche Clinique
- ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
- PANAKEIA - Arzneimittelforschung Leipzig GmbH
- Pharmakologisches Studienzentrum
- Klinikum rechts der Isar der TU München; Klinikapotheke
- Neurologische Praxis Dr. Andrej Pauls
- Universitätsklinikum Ulm; Klinik für Neurologie
- Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
- Semmelweis University; Department of Neurology
- Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
- Umberto I Policlinico di Roma-Università di Roma La Sapienza
- IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
- Irccs Multimedica Santa Maria; Unita' Di Neurologia
- ASST DI MONZA; Neurologia
- A.O. Universitaria Pisana; Neurologia
- Medical Corporation Hakuyokai Kashiwado Hospital
- National Hospital Organization Chiba-east Hospital; Neurology
- Juntendo University Urayasu Hospital; Neurology
- Fukuoka University Hospital; Neurology and Health Care
- Maebashi Red Cross Hospital; Neurology
- National Hospital Organization Hiroshima-Nishi Medical Center
- Hyogo Brain and Heart Center at Himeji; Department of Aging Brain and Cognitive Disorders
- Shonan Kamakura General Hospital; Neurology
- Oita University Hospital; Neurology
- Kurashiki Heisei Hospital; Neurology
- Shizuoka City Shimizu Hospital; Neurology
- Dong-A University Medical Center
- Seoul National University Bundang Hospital; Neurology Department
- Inha University Hospital; Neurology Department
- Konkuk University Medical Center
- Samsung Medical Center
- Ewha Womans University Hospital (Seoul)
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Asan Medical Center.
- Ewha Womans University Mokdong Hospital; Dept of Neurology
- Brain Research Center B.V
- Erasmus Mc - Locatie Centrum; Dept of Neurology
- Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
- Hospital de Santa Maria; Servico de Neurologia
- State Autonomous Healthcare Institution "Republican Clinical Neurological Center
- State autonomous institution of healthcare Inter-regional clinical and diagnostic center
- Institution of RAMS (Mental Health Research Center of RAMS)
- SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
- 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
- Hospital General Universitario de Elche; Servicio de Neurología
- Fundació ACE
- Policlínica Guipuzkoa; Servicio de Neurología
- Hospital de Cruces; Servicio de Neurologia
- Hospital del Mar; Servicio de Neurologia
- Hospital Universitario 12 de Octubre; Servicio de Neurologia
- Hospital Universitario Virgen Macarena; Servicio de Neurologia
- Hospital Universitari i Politecnic La Fe
- Skånes Universitetssjukhus Malmö, Minneskliniken
- KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
- Felix Platter-Spital Medizin Geriatrie
- CHUV Lausanne Memory clinique
- Istanbul University Istanbul School of Medicine; Neurology
- Dokuz Eylul University Medicine Faculty; Noroloji Departmani
- Ondokuz Mayis University School of Medicine; Neurology
- Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
- Glasgow Memory Clinic
- Charing Cross Hospital; Dept of Neurosciences
- Manchester Royal Infirmary
- Royal Preston Hosptial
- Memory Service North
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Part 1 (Double Blind treatment): Placebo
Part 1 (Double Blind treatment): Gantenerumab
Part 2 (Open-Label Extension [OLE] treatment): Placebo switched to Gantenerumab Up to 1200 mg
Part 2 (OLE treatment): Gantenerumab up to 1200 mg
Participants received matching placebo by subcutaneous (SC) injection every 4 weeks (Q4W) up to 100 weeks during Part 1 of the study.
Participants received 105 mg Gantenerumab by SC injection Q4W for 24 weeks and if eligible 225 mg SC injection Q4W from weeks 28-100 during Part 1 of the study.
Participants who had received Placebo in Part 1, received Gantenerumab at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.
Participants who had received Gantenerumab in Part 1, received treatment at doses up to 1200 mg by SC injection Q4W for up to 2 years. Additionally, participants were given the option to continue receiving open-label gantenerumab treatment for 3 years.