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 - EMBARK - 221AD304

IQVIA RDS Netherlands B.V.0 个研究点目标入组 29 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Core treatment period
•- 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.
•LTE Treatment Period:
•- Participant must have completed the Core study period (Week 102) and
•adequately tolerated 10 mg/kg of aducanumab during the Core study period in the
•opinion of the Investigator.
•- Has one informant/care partner who, in the Investigator's opinion, has
•frequent and sufficient 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.

•Core treatment period
•- 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
•-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).
•LTE Treatment Period:
•- Any medical or psychiatric contraindication or clinically significant
•abnormality that, in the opinion of the Investigator, will substantially
•increase the risk associated with the participant's enrollment in and
•completion of the study.
•Other protocol defined Exclusion criteria may apply.

发起方

IQVIA RDS Netherlands B.V.