Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
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.
Key facts
- Study ID
- NCT01677572
- Run by
- Biogen
- People needed
- 197
- Starts
- 2012-10-05
- Expected to finish
- 2019-07-31
- Last updated by the study team
- 2020-08-03
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
Where it is running
- NNS Clinical Research, LLC — Tucson, Arizona, United States
- Senior Clinical Trials, Inc. — Laguna Hills, California, United States
- Torrance Clinical Research Institute, Inc. — Lomita, California, United States
- Collaborative Neuroscience Network, LLC — Long Beach, California, United States
- University of California, Los Angeles — Los Angeles, California, United States
- Pacific Neuroscience Medical Group — Oxnard, California, United States
- Pacific Research Network, Inc. — San Diego, California, United States
- San Francisco Clinical Research Center — San Francisco, California, United States
- Stanford University Medical Center — Stanford, California, United States
- Alzheimer's Disease Research Unit, Yale University — New Haven, Connecticut, United States
- Georgetown University Hospital — Washington D.C., District of Columbia, United States
- Brain Matters Research, Inc. — Delray Beach, Florida, United States
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
- MD Clinical Trials, Inc. — Hallandale, Florida, United States
- Miami Jewish Health Systems — Miami, Florida, United States
- Galiz Research, LLC — Miami Springs, Florida, United States
- Compass Research, LLC — Orlando, Florida, United States
- Infinity Clinical Research, Inc. — Sunrise, Florida, United States
- Axiom Clinical Research of Florida — Tampa, Florida, United States
- Stedman Clinical Trials, LLC — Tampa, Florida, United States
- Neurostudies.net, LLC — Decatur, Georgia, United States
- Alexian Brothers Neurosciences Institute — Elk Grove Village, Illinois, United States
- Indiana University School of Medicine — Indianapolis, Indiana, United States
- St. Louis Clinical Trials, LLC — St Louis, Missouri, United States
- Memory Enhancement Center of America, Inc. — Eatontown, New Jersey, United States
Full record on ClinicalTrials.gov
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