NCT03093519已完成1 期
A Phase 1 Randomized, Double-blind, Placebo-controlled, Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate Alzheimer's Disease
- •Body weight ≥ 40 kg and < 100 kg
- •Clinical Dementia Rating (CDR) score of 1 or 2
- •Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26
排除标准
- •Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
- •Use of another investigational drug within 16 weeks prior to the enrollment
- •Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
- •Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
- •Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
- •Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease
研究组 & 干预措施
KHK6640
Experimental
Intravenous administration
干预措施: KHK6640 (Drug)
Placebo
Placebo Comparator
Intravenous administration
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 197days after first dosing
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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