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

Biogen Idec Research Limited0 sites2,400 target enrollmentStarted: June 30, 2020Last updated: July 6, 2020

Conditions

Trial Snapshot

No summary available.

•- Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (Studies 221AD301, 221AD302, 221AD103 and 221AD205, referred to as 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.
•Other protocol defined Inclusion criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 800

•- 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 stopping 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).
•Other protocol defined Exclusion criteria may apply.

Sponsor