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A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)
A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)
TerminatedPhase 3
Sponsor: Hoffmann-La Roche
Conditions: Alzheimers Disease
Interventions: Gantenerumab, Placebo
Countries: United States, Argentina, Australia, Canada, Italy, Poland, South Korea, Spain
A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).
Eligibility overview
Sex: ALL
Age: 60 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Key Inclusion Criteria: * Willing and able to comply with the study protocol and complete all aspects of the study \[including cognitive and functional assessments, physical and neurological examinations, MRI, CSF collection, genotyping, and positron emission tomography (PET) imaging\]. * Cognitively unimpaired with a screening clinical dementia rating global score (CDR-GS) of 0, and Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) \>=80. * Evidence of cerebral amyloid accumulation. * Participants who have an available person (referred to as a "study partner"). * Fluent in the language of the tests used at the study site. * Adequate visual and auditory acuity, sufficient to perform neuropsychological testing (eye glasses and hearing aids are permitted). * Agreed not to participate in other interventional research studies for the duration of this trial. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 17 weeks after the final dose of study treatment. Key Exclusion Criteria: * Any evidence of an underlying neurological or neurodegenerative condition that may lead to cognitive impairment other than AD. * Clinical diagnosis of mild cognitive impairment (MCI), prodromal AD, or any form of dementia. * History or presence of intracranial or intracerebral vascular malformations, aneurysm, subarachnoid hemorrhage, or intracerebral macrohemorrhage. * History or presence of posterior reversible encephalopathy syndrome. * History of ischemic stroke with clinical symptoms or an acute event that is consistent with a transient ischemic attack within 12 months of screening. * History of severe, clinically significant (i.e., resulting in persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma (e.g., cerebral contusion). * History or presence of intracranial mass lesion (e.g., glioma, meningioma) that could potentially impair cognition or lead to progressive neurological deficits. * Infections that may affect brain function or a history of infections that resulted in neurologic sequelae \[e.g., human immunodeficiency virus (HIV), syphilis, neuroborreliosis, and viral or bacterial meningitis and encephalitis\]. * History of major depression, schizophrenia, schizoaffective disorder, or bipolar disorder. * At risk for suicide. * History of alcohol and/or substance abuse or dependence. * History or presence of clinically significant systemic vascular disease, atrial fibrillation or heart failure. * Within the last year, experienced unstable or clinically significant cardiovascular disease (e.g., myocardial infarction). * Uncontrolled hypertension. * Chronic kidney disease, indicated by creatinine clearance \<30 mL/min. * Confirmed and unexplained impaired hepatic function. * History of, or are known to currently have an HIV infection, or hepatitis B or hepatitis C virus infection that has not been adequately treated. * History or presence of systemic autoimmune disorders that may lead to progressive neurological impairment with associated cognitive deficits. * Systemic immunosuppression or immunomodulation due to the continuing effects of immunosuppressant or immunomodulating medications. * Current COVID-19 infection. * Evidence of folic acid or vitamin B-12 deficiency. * Any passive immunotherapy (Ig) or other long-acting biologic agent to prevent or postpone cognitive decline within 1 year of screening. * Any other investigational treatment within 5 half-lives or 6 months (whichever is longer) prior to screening. * Typical/Atypical anti-psychotic medications or neuroleptic medications. * Anticoagulation medications within 3 months of screening with no plans to initiate any prior to randomization. * Any previous treatment with cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists are exclusionary at screening. * Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the final dose of gantenerumab. * Impaired coagulation. * Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins, including gantenerumab and gantenerumab excipients. * Participants who reside in a skilled nursing facility such as a convalescent home or long-term care facility. * Participants who require residence in such facilities during the study may continue in the study and be followed for efficacy and safety, provided that they have a study partner who meets the study partner requirements.
Locations (63)
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- Sherman Oaks, California, United States
- Atlantis, Florida, United States
- Aventura, Florida, United States
- Bradenton, Florida, United States
- Delray Beach, Florida, United States
- Fort Myers, Florida, United States
- Maitland, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- Stuart, Florida, United States
- The Villages, Florida, United States
- Wellington, Florida, United States
- West Palm Beach, Florida, United States
- Gainesville, Georgia, United States
- Chicago, Illinois, United States
- Wichita, Kansas, United States
- Marrero, Louisiana, United States
- Farmington Hills, Michigan, United States
- Omaha, Nebraska, United States
- Springfield, New Jersey, United States
- East Syracuse, New York, United States
- Matthews, North Carolina, United States
- Columbus, Ohio, United States
- Austin, Texas, United States
- + 33 more on CT.gov