Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01397539 | Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease | PHASE1 | COMPLETED | 53 | — | — | Jun 1, 2011 | Aug 1, 2013 | Mar 23, 2015 | 3 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| BIIB037 | EXPERIMENTAL | A single dose of BIIB037 by intravenous infusion. |
| Placebo | PLACEBO_COMPARATOR | A single dose of placebo matching BIIB037 by intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| BIIB037 | DRUG | 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. |
| Placebo | OTHER | Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion. |
Key Inclusion Criteria: * Must be ambulatory * Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the following: 1. Probable Alzheimer's Disease (AD), according to National Institute of Neurological and Communicative Disease and Stroke and Alzheimer's Disease and Related ...