Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in Aducanumab Studies (EMBARK)

Active Trial/Not Recruiting

Purpose

The Biogen EMBARK study is a Phase 3 study evaluating the long-term safety and tolerability of aducanumab (Aduhelm) after a wash-out period imposed by discontinuation of earlier studies. This study enrolled participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants). This study is not recruiting new participants at this time. During the study, participants will receive the study drug, aducanumab (Aduhelm) at a dose of 10mg/kg by intravenous infusions every four weeks for a total duration of 100 weeks. Study visits consist of regular safety tests and cognitive assessments throughout the study. At the end of the study, there is a follow-up period which involves returning to the study center approximately 2 weeks after a participant’s last dose of aducanumab for clinical assessments. Participants will also return to the study center for a safety follow-up visit about 18 weeks (about 4 months) after their last dose of the study drug. To learn more, please call Celine Ossinalde at (310) 794-6191 or send an email to: This email address is being protected from spambots. You need JavaScript enabled to view it.. (PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Dev. Program)

Sponsor: Biogen
ClinicalTrials.gov Identifier: NCT04241068

 

Condition: Intervention: Phase:
Alzheimer's Disease

Drug: Aducanumab
Other Name: BIIB037
Phase III

 

Study Type: Interventional
Estimated Enrollment: 1695 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Length of Study: Up to Week 118
Eligibility
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Criteria

Source: ClinicalTrials.gov

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.

Contact: Celine Ossinalde at (310) 794-6191 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.

Health Professionals