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.
The study consists of a placebo-controlled period to study week 54, followed by a long-term extension to study week 518. The placebo-controlled period 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, 2 additional treatment arms beginning in parallel, and the last 2 treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period for up to 42 additional doses of active drug for the first 3 years of LTE. Furthermore, up until the last participant in Arms 8 and 9 has had his or her last dose in the fifth year of the LTE, eligible participants will be able to continue treatment beyond the third year of the LTE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
197
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 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.
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
Number of Participants with Adverse Events
Time frame: Baseline to week 518
Change from baseline in florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging in certain brain areas.
Time frame: Day 1, Weeks 26, 54, End of year 2, 3, and 4
Multiple dose pharmacokinetic (PK) serum concentrations of Aducanumab
Time frame: Up to week 518
Change from Baseline in Incidence of Anti-Aducanumab Antibodies in Serum.
Time frame: Up to week 518
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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
...and 22 more locations