A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

• Status: Active, not recruiting
• Trial end date: 2023-10-11
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the long-term safety and tolerability of aducanumab 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

Criteria

Inclusion 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.