Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease

Summary

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose serum concentrations of Aducanumab and to evaluate the immunogenicity of Aducanumab after multiple dose administration in this population.

Timeline

Start

2012-10-05

Primary completion

2019-07-31

Completion

2019-07-31

Publications

• Chen T, O'Gorman J, Castrillo-Viguera C, Rajagovindan R, Curiale GG, Tian Y, Patel D, von Rosenstiel P, von Hehn C, Salloway S, Hock C, Nitsch RM, Haeberlein SB, Sandrock A, Singhal P. Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab. Alzheimers Dement. 2024 May;20(5):3406-3415. doi: 10.1002/alz.13755. Epub 2024 Apr 3.
• Sevigny J, Chiao P, Bussiere T, Weinreb PH, Williams L, Maier M, Dunstan R, Salloway S, Chen T, Ling Y, O'Gorman J, Qian F, Arastu M, Li M, Chollate S, Brennan MS, Quintero-Monzon O, Scannevin RH, Arnold HM, Engber T, Rhodes K, Ferrero J, Hang Y, Mikulskis A, Grimm J, Hock C, Nitsch RM, Sandrock A. The antibody aducanumab reduces Abeta plaques in Alzheimer's disease. Nature. 2016 Sep 1;537(7618):50-6. doi: 10.1038/nature19323.

Drugs

Indications