A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease
October 26, 2016
Aimee Pierce, MD
UCI campus (UCI MIND Gottschalk Medical Plaza, ICTS in Hewitt Hall, Neuro Imaging Center), Newport Diagnostic Center
To evaluate whether an investigational drug, aducanumab, has the potential to be a helpful treatment that slows down disease progression in subjects with early Alzheimer's disease (AD) by comparing it to placebo and to evaluate its safety (side effects), and to find out more about aducanumab.
Male and female participants ages 50 to 85 years old, who have been diagnosed with early Alzheimer's disease (mild cognitive impairment), with evidence of amyloid pathology on a brain scan. All study subjects must have an informant/care partner who can attend required study visits and can provide accurate information about the subject's cognitive and functional abilities.
Screening phase (up to 8 weeks). If you are eligible for the treatment phase, you will receive placebo or aducanumab and have 32 visits over the course of up to 78 weeks.
You may or may not receive any benefit from being in this study. If you are in the group that receives the study drug, aducanumab, and it proves to treat your condition better than placebo, you may benefit from participating in the study, but this cannot be guaranteed.
The information collected from this study may increase knowledge regarding the treatment of Alzheimer's disease and help people in the future.
Participants are eligible to receive the following compensation in cash during the course of this study:
- $40 cash for each scheduled in-person study visit; there are 26 such visits.
- $40 cash for each scheduled brain MRI; there are 8 scheduled brain MRIs.
- $100 cash for the PET scan.
Total compensation for participation in the entire study is $1,460.
Optional studies: Participants can receive additional compensation of up to $400 for participation in optional studies.
If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits and/or procedures that you have completed.
You will not be reimbursed for any out-of-pocket expenses, such as parking or transportation fees.
Huong Nguyen, Clinical Trials Research Inquiry Coordinator