The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
As described in the treatment arm
IV administration of 0.9% sodium chloride
Research Site
Tōon, Ehime, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kamakura, Kanagawa, Japan
Research Site
Kanzaki, Saga-ken, Japan
Incidence and nature of adverse events (AE) / serious adverse events(SAE)
Time frame: Up to week 42
Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations
Time frame: Up to week 42
Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)
Time frame: Up to week 42
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)
Time frame: Up to 8 weeks post dosing
AUC from time zero to time of the last measurable concentration (AUC0-last)
Time frame: Up to 8 weeks post dosing
Maximum observed concentration (Cmax)
Time frame: Up to 8 weeks post dosing
Time to Cmax (Tmax)
Time frame: Up to 8 weeks post dosing
Elimination half-life (t1/2)
Time frame: Up to 8 weeks post dosing
Volume of distribution at steady state (Vss)
Time frame: Up to 8 weeks post dosing
Clearance (CL) after a single IV infusion of aducanumab
Time frame: Up to 8 weeks post dosing
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Research Site
Kodaira, Tokoyo, Japan
Research Site
Shinjuku, Tokoyo, Japan
Research Site
Kyoto, Japan
Incidence of anti-aducanumab antibodies in serum
Time frame: Up to week 42