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
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT04241068
- Lead Sponsor
- Biogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 1696
Key Inclusion Criteria:<br><br>Core Treatment Period:<br><br> - Participant was participating in an aducanumab clinical study at the time of the<br> announcement of early termination (feeder studies).<br><br> - Has one care partner who, in the Investigator's opinion, has adequate contact with<br> the participant as to be able to provide accurate information about the<br> participant's cognitive and functional abilities.<br><br>LTE Treatment Period:<br><br> - Participant must have completed the Core study period (Week 102) and adequately<br> tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the<br> Investigator.<br><br> - Has one informant/care partner who, in the Investigator's opinion, has frequent and<br> sufficient contact with the participant as to be able to provide accurate<br> information about the participant's cognitive and functional abilities.<br><br>Key Exclusion Criteria:<br><br>Core Treatment Period:<br><br> - Any medical or neurological condition (other than Alzheimer's Disease) that might be<br> a contributing cause of the participant's cognitive impairment.<br><br> - Stroke or any unexplained loss of consciousness within 1 year prior to Screening.<br><br> - Clinically significant unstable psychiatric illness in past 6 months.<br><br> - History of unstable angina, myocardial infarction, advanced chronic heart failure,<br> or clinically significant conduction abnormalities within 1 year prior to Screening.<br><br> - A seizure event that occurred after the last visit of the feeder study and before<br> Screening for this study.<br><br> - Evidence of impaired liver function as shown by an abnormal liver function profile<br> at Screening.<br><br> - History of or known seropositivity for HIV.<br><br> - Clinically significant systemic illness or serious infection within 30 days prior to<br> or during Screening.<br><br> - Contraindications to having a brain magnetic resonance imaging (MRI).<br><br>LTE Treatment Period:<br><br> - Any medical or psychiatric contraindication or clinically significant abnormality<br> that, in the opinion of the Investigator, will substantially increase the risk<br> associated with the participant's enrollment in and completion of the study.<br><br>Note- Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs);Core Treatment Period: Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal;Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E);Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H);Core Treatment Period: Number of Participants With Antidrug Antibodies (ADAs) in Serum
- Secondary Outcome Measures
Name Time Method