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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 1,696
- 试验地点
- 259
- 主要终点
- Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
研究概览
简要总结
The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Core Treatment Period:
- •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.
- •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.
排除标准
- •Core Treatment Period:
- •Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant'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.
- •Note- Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Aducanumab
Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period.
干预措施: Aducanumab (Drug)
结局指标
主要结局
Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
时间窗: From the first dose of study drug to end of follow-up (up to Week 118)
An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal(investigational) product, whether or not related to medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in significant disability/incapacity or congenital anomaly, is medically important event. TEAE or Serious TEAEs are defined as any AE that has an onset date and time that is on or after date and time of first dose of study treatment, or that has worsened after date and time of first dose of study treatment.
Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW)
时间窗: From the first dose of study drug to end of follow-up (up to Week 118)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E)
时间窗: Up to Week 118
Number of participants diagnosed with ARIA edema are reported.
Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum
时间窗: Up to Week 102
The presence of serum ADAs was determined using a validated assay. A standard 3-tiered approach was used including screening assay, confirmatory assay, and titration assay. The number of participants with a positive response to ADAs are reported.
Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)
时间窗: Up to Week 118
Number of participants diagnosed with ARIA hemmorrhage or superficial siderosis are reported.
次要结局
未报告次要终点