197
Participants
Start Date
October 5, 2012
Primary Completion Date
July 31, 2019
Study Completion Date
July 31, 2019
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study is conducted with a staggered, parallel group design, with the first 3 treatment arms conducted in parallel, 2 further treatment arms subsequently beginning in parallel and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Empire Neurology, PC, Latham
Georgetown University Hospital, Washington D.C.
Neurostudies.net, LLC, Decatur
Compass Research, LLC, Orlando
MD Clinical Trials, Inc., Hallandale
Miami Jewish Health Systems, Miami
Galiz Research, LLC, Miami Springs
Infinity Clinical Research, Inc., Sunrise
Brain Matters Research, Inc., Delray Beach
Axiom Clinical Research of Florida, Tampa
Stedman Clinical Trials, LLC, Tampa
Neuropsychiatric Research Center of Southwest Florida, Fort Myers
Insight Clinical Trials LLC, Beachwood
Indiana University School of Medicine, Indianapolis
Alexian Brothers Neurosciences Institute, Elk Grove Village
St. Louis Clinical Trials, LLC, St Louis
NNS Clinical Research, LLC, Tucson
University of California, Los Angeles, Los Angeles
Torrance Clinical Research Institute, Inc., Lomita
Collaborative Neuroscience Network, LLC, Long Beach
Pacific Research Network, Inc., San Diego
Senior Clinical Trials, Inc., Laguna Hills
Pacific Neuroscience Medical Group, Oxnard
San Francisco Clinical Research Center, San Francisco
Stanford University Medical Center, Stanford
Summit Research Network (Oregon) Inc., Portland
Alzheimer's Disease Research Unit, Yale University, New Haven
Memory Enhancement Center of America, Inc., Eatontown
CRI Lifetree, Marlton
Advanced Memory Research Institute of NJ, Toms River
Brown Hospital, East Providence
Rhode Island Hospital, Providence
Lead Sponsor
Biogen
INDUSTRY