Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT01397539|
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : March 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: BIIB037 Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|