An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
- Registration Number
- NCT03491150
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 149
- Previous participation in Study BN29552 or BN29553 and completion of the Week 105 visit.
- Able to provide written informed consent by the patient or legally authorized representative, if required.
- Every effort to have the same caregiver participate throughout the duration of the OLE (Open Label Extension) study who also participated in Study BN29552 or BN29553.
- Willingness and ability to complete all aspects of the study [including MRI (Magnetic Resonance Imaging), lumbar puncture [if applicable], and PET (Positron Emission Tomography) imaging [if applicable].
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a protocol approved contraceptive method and agreement to refrain from donating eggs for at least 8 weeks after last dose.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a protocol approved contraceptive method for at least 8 weeks after last dose.
- Patients who discontinued treatment permanently in Study BN29552 or BN29553 for safety reasons.
- Impaired coagulation.
- Evidence of more than 10 microbleeds and/or ARIA-H (amyloid-related imaging abnormalities-hemosiderin deposition) at the Study BN29552 or BN29553 Week 105 visit, as assessed by central review of MRI.
- Diagnosed with three recurrent, symptomatic ARIA-E (amyloid-related imaging abnormalities-edema/effusion) events or exacerbations of previous events.
- Presence of intracranial lesion that could potentially increase the risk of CNS (Central Nervous System) bleeding.
- At risk of suicide in the opinion of the investigator.
- Alcohol and/or substance abuse or dependence within the past 2 years and during the study.
- Inability to tolerate MRI procedures or contraindication to MRI, including, but not limited to, presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan; or any other clinical history or examination finding that, in the judgment of the investigator, would pose a potential hazard in combination with MRI.
- Pregnant or lactating, or intending to become pregnant during the study.
- Any other severe or unstable medical condition that, in the opinion of the investigator or Sponsor, could be expected to progress, recur, or change to such an extent that it could put the patient at special risk, bias the assessment of the clinical or mental status of the patient to a significant degree, or interfere with the patient's ability to complete the study assessments.
- Chronic use of anticoagulants or participation in any other investigational drug treatment trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Parent Crenezumab Crenezumab Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). Parent Placebo Crenezumab Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
- Primary Outcome Measures
Name Time Method Percentage of Participants With Anti-Crenezumab Antibodies Baseline up to end of study (up to 54 weeks). Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks). An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
Anderson Clinical Research, Inc.
🇺🇸Redlands, California, United States
University of California, Davis; Alzheimers Disease Center, Department of Neurology
🇺🇸Sacramento, California, United States
Hopital La Grave; Place Lange
🇫🇷Toulouse Cedec, France
Senior Adults Specialty Research
🇺🇸Austin, Texas, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Southern Illinois University, School of Medicine
🇺🇸Springfield, Illinois, United States
Alexian Brothers Neurosci Inst
🇺🇸Elk Grove Village, Illinois, United States
Ondokuz Mayis Univ. Med. Fac.; Neurology
🇹🇷Samsun, Turkey
Clinica Universitaria de Navarra; Servicio de Neurología
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario 12 de Octubre; Servicio de Neurologia
🇪🇸Madrid, Spain
MMP Neurology
🇺🇸Scarborough, Maine, United States
Research Center for Clinical Studies, Inc.
🇺🇸Norwalk, Connecticut, United States
NeuroStudies.net, LLC
🇺🇸Decatur, Georgia, United States
MidAmerica Neuroscience Institute
🇺🇸Prairie Village, Kansas, United States
Neurodegenerative Disorders Research; Neurology
🇦🇺West Perth, Western Australia, Australia
Shankle Clinic
🇺🇸Newport Beach, California, United States
Neurological Research Inst
🇺🇸Santa Monica, California, United States
Brain Matters Research, Inc.
🇺🇸Delray Beach, Florida, United States
Behavioral Health Research
🇺🇸Charlotte, North Carolina, United States
Guilford Neurologic Associates
🇺🇸Greensboro, North Carolina, United States
SHI City Psychoneurological Dispensary #7 (with Hospital)
🇷🇺St. Petersburg, Russian Federation
Hospital General De Catalunya; Servicio de Neurologia
🇪🇸Sant Cugat del Valles, Barcelona, Spain
Hospital Mutua De Terrasa; Servicio de Neurologia
🇪🇸Terrassa, Barcelona, Spain
Hospital Virgen del Puerto. Servicio de Neurología
🇪🇸Plasencia, Caceres, Spain
Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit
🇬🇧Chertsey, United Kingdom
Oklahoma Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
UCSF - Memory and Aging Center
🇺🇸San Francisco, California, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Associated Neurologists PC - Danbury
🇺🇸Danbury, Connecticut, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
🇦🇺Heidelberg West, Victoria, Australia
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
Alzheimer's Research and Treatment Center
🇺🇸Lake Worth, Florida, United States
Terveystalo Tampere
🇫🇮Tampere, Finland
The Cognitive and Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
Devonshire Clinical Research Inc.
🇨🇦Woodstock, Ontario, Canada
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
Parkwood Hospital; Geriatric Medicine
🇨🇦London, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
🇨🇦Peterborough, Ontario, Canada
Summit Research Network Inc.
🇺🇸Portland, Oregon, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
🇮🇹Roma, Lazio, Italy
Advanced Memory Research Institute of NJ
🇺🇸Toms River, New Jersey, United States
The Centre for Memory and Aging
🇨🇦Toronto, Ontario, Canada
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
🇩🇪München, Germany
Vilnius University Hospital Santariskiu Clinic
🇱🇹Vilnius, Lithuania
State Autonomous Healthcare Institution "Republican Clinical Neurological Center
🇷🇺Kazan, Russian Federation
Fundació ACE
🇪🇸BArcelon, Barcelona, Spain
Fondazione Santa Lucia IRCCS
🇮🇹Roma, Lazio, Italy
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
🇲🇽Culiacan, Mexico
Hospital Uni; Dr. Jose E. Gonzalez
🇲🇽Monterrey, Mexico
AVIX Investigación Clínica S.C
🇲🇽Monterrey, Mexico
Hospital Universitario de Saltillo
🇲🇽Saltillo, Mexico
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
🇷🇺Kazan, Russian Federation
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Poland
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Abington Neurological Associates
🇺🇸Willow Grove, Pennsylvania, United States
Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
National Clinical Research Inc.-Richmond
🇺🇸Richmond, Virginia, United States
Bioclinica Research
🇺🇸Orlando, Florida, United States
Charing Cross Hospital
🇬🇧London, United Kingdom
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
🇭🇰Hong Kong, Hong Kong