Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Blinded, Placebo-Controlled Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB037 in Subjects With Mild to Moderate Alzheimer's Disease|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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).
- Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Maximum Concentration [Cmax] of BIIB037 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Time to Cmax [Tmax] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Elimination Half-life [t1/2] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Clearance [Cl] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Incidence of Anti-BIIB037 Antibodies in Serum [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
A single dose of BIIB037 by intravenous infusion.
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 Comparator: Placebo
A single dose of placebo matching BIIB037 by intravenous infusion.
Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397539
|United States, Florida|
|Brain Matters Research|
|Delray Beach, Florida, United States, 33445|
|Compass Research, LLC|
|Orlando, Florida, United States, 32806|
|United States, Ohio|
|Insight Clinical Trials, LLC|
|Beachwood, Ohio, United States, 44122|
|Study Director:||Medical Director||Biogen Idec|