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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo |
|
| Cohort 2 | Experimental | IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo |
|
| Cohort 3 | Experimental | IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo |
|
| Cohort 4 | Experimental | IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aducanumab | Drug | As described in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of adverse events (AE) / serious adverse events(SAE) | Up to week 42 | |
| Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations | 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) | Up to week 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) | Up to 8 weeks post dosing | |
| AUC from time zero to time of the last measurable concentration (AUC0-last) | Up to 8 weeks post dosing |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tōon | Ehime | Japan | |||
| Research Site |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000600266 | aducanumab |
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| Placebo | Drug | IV administration of 0.9% sodium chloride |
|
| Maximum observed concentration (Cmax) | Up to 8 weeks post dosing |
| Time to Cmax (Tmax) | Up to 8 weeks post dosing |
| Elimination half-life (t1/2) | Up to 8 weeks post dosing |
| Volume of distribution at steady state (Vss) | Up to 8 weeks post dosing |
| Clearance (CL) after a single IV infusion of aducanumab | Up to 8 weeks post dosing |
| Incidence of anti-aducanumab antibodies in serum | Up to week 42 |
| Kobe |
| Hyōgo |
| Japan |
| Research Site | Kamakura | Kanagawa | Japan |
| Research Site | Kanzaki | Saga-ken | Japan |
| Research Site | Kodaira | Tokoyo | Japan |
| Research Site | Shinjuku | Tokoyo | Japan |
| Research Site | Kyoto | Japan |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |