A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects with Prodromal or Mild Alzheimers Disease (221AD103)

Conditions

What is the purpose of this trial?

The primary objective of the study is to evaluate the safety and tolerability of multiple doses of BIIB037 in subjects with prodromal or mild AD. The secondary objectives of this study are: To assess the effect on cerebral amyloid plaque content as measured by 18F-AV-45 PET imaging (at Week 18). To assess the multiple dose serum concentrations of BIIB037. To evaluate the immunogenicity of BIIB037 after multiple dose administration in this population. The exploratory objectives of the study are: To assess the effects clinical of BIIB037, disease-related biomarkers in blood, cerebral amyloid plaque content as measured by 18F-AV-45 PET imaging (at Week 30). To measure cerebral amyloid plaque content as measured by 18F-AV-45 PET imaging in APOE carriers and non-carriers (at Week 18 and Week 30). To assess cerebral blood flow as measured by arterial spin labeling magnetic resonance imaging (ASL-MRI). To measure various morphometric measures in certain brain areas as measured by MRI.

Participation Guidelines

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Sponsor:
Biogen Idec, Inc.
Dates:
10/25/2012
Last Updated:
Study HIC#:
1207010508