Aducanumab (BIIB037), an anti-amyloid beta monoclonal antibody, in patients with prodromal or mild Alzheimer’s disease: Interim results of a randomized, double-blind, placebo-controlled, phase 1b study

@article{Sevigny2015AducanumabA,
  title={Aducanumab (BIIB037), an anti-amyloid beta monoclonal antibody, in patients with prodromal or mild Alzheimer’s disease: Interim results of a randomized, double-blind, placebo-controlled, phase 1b study},
  author={Jeff Sevigny and Ping Chiao and Leslie Williams and Tianle Chen and Yan Ling and John O’Gorman and Christoph Hock and Roger M. Nitsch and Alfred W. Sandrock},
  journal={Alzheimer's \& Dementia},
  year={2015},
  volume={11}
}
statistically significant treatment differences for t-tau or p-tau in any population. Conclusions:Amyloid PET GCA SUVr decreases 10mg pooled dose suggests target engagement. There was no effect on neuronal injury biomarkers (p-tau and t-tau). Greater brain volume decreases in the MTM treatment groups was consistent with prior AD immunotherapy trials but the absence of treatment related differences in the small eAD study should be interpreted with caution. 
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34 Citations
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34 Citations

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Anti-Aβ Autoantibodies in Amyloid Related Imaging Abnormalities (ARIA): Candidate Biomarker for Immunotherapy in Alzheimer’s Disease and Cerebral Amyloid Angiopathy
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A critically review the growing body of evidence supporting the monitoring of CSF anti-Aβ autoantibody as a promising candidate biomarker for ARIA in clinical trials.
Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study
The safety, pharmacokinetics, and effect on peripheral and central amyloid β (Aβ) of multiple doses of ponezumab, an anti‐Aβ monoclonal antibody, were characterized in subjects with mild‐to‐moderate…
Developing therapeutic vaccines against Alzheimer’s disease
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Greater therapeutic efficacy for the next generation of vaccine approaches will likely benefit from specifically targeting the most toxic species of Aβ and tau, ideally simultaneously.
NPT088 reduces both amyloid-β and tau pathologies in transgenic mice
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A fusion protein is engineered consisting of the active fragment of g3p and human‐IgG1‐Fc that binds to and remodels misfolded aggregates of proteins that assume an amyloid conformation in AD.
First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease
Aducanumab (BIIB037), a human monoclonal antibody selective for aggregated forms of amyloid beta, is being investigated as a disease‐modifying treatment for Alzheimer's disease (AD).
Targeting microglia for the treatment of Alzheimer's Disease
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The considerations in selecting microglial therapeutic targets from the perspective of drug discovery feasibility are discussed, and the role of microglia in ongoing immunotherapy clinical strategies is considered.
Molecular Imaging in Alzheimer Clinical Trials
TLDR
Back-translation of molecular PET imaging to rodent models of AD pathology has been achieved and could allow for mechanistic studies of how the PET signal evolves, and allow selection and identification of exposure ranges of candidate treatments and in considerably less time and with less expense than are required for clinical trials.
Emerging amyloid and tau targeting treatments for Alzheimer’s disease
TLDR
There is a significant need for further research targeting the disease at an earlier stage and progress in biomarker and imaging technology are improving the outlook, allowing development of effective targeted treatments.
Ten Challenges of the Amyloid Hypothesis of Alzheimer's Disease.
  • K. P. Kepp
  • Medicine
    Journal of Alzheimer's disease : JAD
  • 2017
TLDR
Ten central, current challenges of the major paradigm in the field of Alzheimer's disease, the amyloid hypothesis, are sharply formulated and show that new approaches are necessary that address data heterogeneity, increase focus on the proteome level, use available human patient data more actively, and combine into one framework both the familial and sporadic forms of the disease.
Efficacy and safety of anti‐amyloid‐β immunotherapy for Alzheimer's disease: a systematic review and network meta‐analysis
TLDR
Given the clinical therapeutic effects of anti‐Aβ immunotherapies for AD, aducanumab and solanezumab improve the cognitive function, while aducanical and bapineuzumab may increase the risks of ARIA.
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