NL-OMON49765撤回2 期
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease - M15-570
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject has voluntarily provided written informed consent
- •- Subject completed the 96-week treatment period of Study M15-566.
- •- Subject has an identified, reliable study partner who has frequent contact
- •with the subject and who will provide information as to the subject's cognitive
- •and functional abilities.
- •- The study partner has provided written informed consent.
- •- If female, subject must be postmenopausal or permanently surgically sterile
- •(bilateral oophorectomy, bilateral salpingectomy or
- •hysterectomy).
- •- If the male subject is sexually active with female partner(s) of childbearing
- •potential, he must agree, from Study Day 1 through 20 weeks after the last dose
- •of study drug to practice the protocol specified contraception and must refrain
- •from sperm donation.
排除标准
- •- Subject has any significant change in his/her medical condition since
- •participation in Study M15-566 that could interfere with the subject's
- •participation in Study M15-570, could place the subject at increased risk,or
- •could confound interpretation of study results. This would include any
- •clinically significant neurological, hematological, autoimmune, endocrine,
- •cardiovascular, neoplastic, renal, hepatic, metabolic, psychiatric, pulmonary,
- •gastrointestinal, or other major disorder or contraindication to or inability
- •to tolerate brain MRI or PET scans.
- •- More than 8 weeks have elapsed since the subject received his/her last dose
- •of study drug in Study M15-566.
- •- Subject is concurrently enrolled in another interventional clinical study
- •(with the exception of Study M15-566) involving a therapeutic agent.
- •- Subject is considered by the investigator to be an unsuitable candidate to
- •receive ABBV-8E12 or the subject is considered by the investigator to be unable
- •or unlikely to comply with the dosing schedule or study evaluations.
研究者
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