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临床试验/JPRN-jRCT2080223486
JPRN-jRCT2080223486未知1 期

KHK6640 Phase1 study (A Phase1 Randomized, Placebo-Controlled, Double-Blind, Repeated Dose Study of KHK6640 in Japanese Patients with Alzheimer's Disease)

Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 5 人开始时间: 2017年3月22日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
5

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 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 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

发起方
Kyowa Hakko Kirin Co., Ltd.

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