The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of BIIB037 after single-dose administration.
BIIB037 is an investigational product being developed as a treatment for Alzheimer's disease (AD). BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is selective for the fibrillar form of beta amyloid (Aß).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg.
Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.
Brain Matters Research
Delray Beach, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Insight Clinical Trials, LLC
Beachwood, Ohio, United States
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), and brain MRI findings (including the occurrence of vasogenic edema and incident hemorrhage).
Time frame: 6 months
Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞]
Time frame: 6 months
Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast]
Time frame: 6 months
Maximum Concentration [Cmax] of BIIB037
Time frame: 6 Months
Time to Cmax [Tmax]
Time frame: 6 Months
Elimination Half-life [t1/2]
Time frame: 6 Months
Clearance [Cl]
Time frame: 6 Months
Incidence of Anti-BIIB037 Antibodies in Serum
Time frame: 6 Months
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