Aducanumab is a human monoclonal antibody designed for the treatment of Alzheimer's disease (AD). It is being developed by Biogen in collaboration with Neurimmune, which licensed the compound to Biogen. It targets aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque found in the brain of AD patients.[medical citation needed]
The Phase 1b clinical trial of aducanumab, known as PRIME, in an ongoing randomized, double-blind, placebo-controlled, dose-dependent study which aims to evaluate the safety and tolerability of the drug while also measuring the pharmacokinetics and pharmacodynamics. The target population includes patients with prodromal or mild Alzheimer's disease. The trial began recruiting patients in June 2011. Interim results indicate that aducanumab has a dose and time dependent effect in the reduction of amyloid plaque. A composite standardized uptake value ratio uses PET imaging to compare amyloid plaque volume throughout the study. The results show a significant decrease in amyloid plaque volume in the 3 mg/kg [-0.139 (p<0.001)] and 10 mg/kg [-0.266 (p<0.001) groups at 54 weeks, when compared to placebo. Both the 3 mg/kg and 10 mg/kg groups also displayed significant slowing of cognitive decline.
Though aducanumab demonstrated an "acceptable" safety and tolerability profile, there are concerns that the most frequently reported adverse event, a type of edema known as amyloid-related imaging abnormalities (ARIA), may pose a serious risk as it appears to be both time and dose dependent. There are also concerns that the small numbers of subjects in placebo (n=40) and each treatment group (ns of ~ 30) mean that aducanumab is less efficacious than the results suggest.
- Statement On A Nonproprietary Name Adopted By The USAN Council - Aducanumab, American Medical Association
- Biogen Idec Presents Positive Interim Results from Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab (BIIB037) at 2015 AD/PD™ Conference, "BusinessWire"
- Biogen Drug Could Inspire New Hope For Alzheimer's Treatments, "Forbes"
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