JPRN-jRCT2080222766未知1 期
KHK6640 Phase I study (A single dose study in patients with Alzheimer's disease)
Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 20 人开始时间: 2015年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
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 <= 84age old（—）
- 性别
- All
入选标准
- •Patients with mild to moderate AD
- •- Body weight >= 40 kg and < 100 kg
- •- CDR score of 1 or 2
- •- MMSE score of >= 17 and =< 26
排除标准
- •- Previous active treatment with an AD immunotherapy in an investigational study
- •- Use of another investigational drug within 4 months 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 who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD
- •- Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
研究者
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