The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD dementia. The secondary objective of the study is to characterize ARIA, from both the imaging and the clinical perspective and to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of aducanumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Pacific Research Network, Inc
San Diego, California, United States
California Neuroscience Research Medical Group Inc.
Sherman Oaks, California, United States
JEM Research Institute
Atlantis, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Bioclinica Orlando
Orlando, Florida, United States
...and 12 more locations
Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)
Time frame: up to Week 54
Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)
ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).
Time frame: up to Week 54
Time to Onset of ARIA as Obtained on MRI
Time frame: up to Week 54
Time to Resolution of ARIA as Obtained on MRI
Time frame: up to Week 54
Number of Participants With Symptomatic ARIA by Severity
ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).
Time frame: up to Week 54
Time to Onset of Symptomatic ARIA
Time frame: up to Week 54
Time to Resolution of Symptomatic ARIA
Time frame: up to Week 54
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Time frame: up to Week 54
Change From Baseline in the Montreal Cognitive Assessment (MoCA) at Week 54
Time frame: Baseline, Week 54
Number of Participants With Aducanumab Concentration in Serum
Time frame: up to Week 54
Number of Participants With Antiaducanumab Antibodies in Serum
Time frame: up to Week 54
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