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

Phase 3

Recruiting

• Conditions: Alzheimer's Disease; 10057167

• Registration Number: NL-OMON52801
• Lead Sponsor: IQVIA RDS Netherlands B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 29

Inclusion Criteria

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.

Exclusion Criteria

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
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).

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br>Incidence of AEs, SAEs, ARIA, and immunogenicity over 100 weeks of treatment<br /><br>and/or re-exposure to aducanumab. Safety and tolerability parameters include<br /><br>the following:<br /><br>• Incidence of all AEs, AEs leading to treatment discontinuation or study<br /><br>withdrawal, and all SAEs<br /><br>• Incidence of ARIA-E and ARIA-H<br /><br>• Incidence of ADAs in serum</p><br>