A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813

Eli Lilly Japan K.K.0 个研究点开始时间: 2016年3月11日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
•-Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
•-Have a caregiver/study informant who provides a separate written informed consent to participate
•-Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
•-Positive florbetapir scan

•-Do not have a reliable caregiver/study informant who is in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
•-Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study
•-History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
•-Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
•-Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
•-Have gamma globulin therapy within the last 6 months
•-Previously dosed in any other study investigating active immunization against amyloid beta (A beta)
•-Previously dosed in any other study investigating passive immunization against A beta
•-Have current serious or unstable illnesses

发起方