JPRN-jRCT2031220335进行中（未招募）3 期
A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease - I5T-MC-AACM
Masaki Takeshi0 个研究点目标入组 3,300 人开始时间: 2022年9月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,300
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
- >= 55age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
- •-Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.
- •-Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
- •-Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
- •-Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •-Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.
排除标准
- •-Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
- •-Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately <=5 years.
- •-History of cancer with high risk of recurrence and preventing completion of the trial.
- •-History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
- •-Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.
- •-Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- •-Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.
- •-Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.
- •-Have received active immunization against amyloid beta in any other study.
- •-Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.
研究者
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