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) (SKYLINE)

  • STATUS
    Recruiting
  • End date
    Oct 13, 2028
  • participants needed
    1200
  • sponsor
    Hoffmann-La Roche
Updated on 28 July 2022
positron emission tomography
dementia
amyloid

Summary

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).

Details
Condition Alzheimers Disease
Treatment Placebo, Gantenerumab
Clinical Study IdentifierNCT05256134
SponsorHoffmann-La Roche
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

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

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
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