jRCT2031240502进行中（未招募）不适用
A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline (J1G-MC-LAKI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 55age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
- •Have 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.
- •Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
- •Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
- •If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
排除标准
- •Have dementia or significant other neurological disease that can affect cognition.
- •Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
- •Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
- •Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
- •Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to radomization, that could be detrimental to the participant or could compromise the study.
- •Have any contraindications for magnetic resonance imaging (MRI).
- •Have a centrally read MRI that does not meets study entry criteria.
- •Prior or Current Therapies
- •Have ever had prior treatment with a passive anti-amyloid immunotherapy.
- •Have received active immunization against AB in any other study.
结局指标
主要结局
-
Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR) [ Time Frame: Baseline to Time to Event up to Week 255 Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).
次要结局
未报告次要终点
研究者
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