Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer’s Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
Sponsor:
Brief Summary:
after a wash-out period imposed by discontinuation of feeder studies in participants who had
previously received aducanumab (i.e. previously treated participants) or who had previously
received placebo (i.e. treatment-naïve participants).
Criteria
– Participant was participating in an aducanumab clinical study at the time of the
announcement of early termination (feeder studies).
– Has one care partner who, in the Investigator’s opinion, has adequate contact with the
participant as to be able to provide accurate information about the participant’s
cognitive and functional abilities.
Exclusion Criteria:
– Any medical or neurological condition (other than Alzheimer’s Disease) that might be a
contributing cause of the subject’s cognitive impairment.
– Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
– Clinically significant unstable psychiatric illness in past 6 months.
– History of unstable angina, myocardial infarction, advanced chronic heart failure, or
clinically significant conduction abnormalities within 1 year prior to Screening.
– A seizure event that occurred after the last visit of the feeder study and before
Screening for this study.
– Evidence of impaired liver function as shown by an abnormal liver function profile at
Screening.
– History of or known seropositivity for HIV.
– Clinically significant systemic illness or serious infection within 30 days prior to
or during Screening.
– Contraindications to having a brain magnetic resonance imaging (MRI).
Note- Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
- Neurology Center of North Orange County, Fullerton, California, United States, 92835
- Senior Clinical Trials, Inc., Laguna Hills, California, United States, 92653
- Pacific Neuroscience Medical Group, Oxnard, California, United States, 93030
- Anderson Clinical Research, Redlands, California, United States, 92374
- Pacific Research Network, Inc., San Diego, California, United States, 92103
- Pacific Research Network, Inc, San Diego, California, United States, 92103
- Syrentis Clinical Research, Santa Ana, California, United States, 92705
- California Neuroscience Research Medical Group Inc., Sherman Oaks, California, United States, 91403
