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临床试验/NCT01600859
NCT01600859已完成1 期

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease

Eisai Inc.0 个研究点目标入组 65 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Eisai Inc.
入组人数
65
主要终点
Percent change from baseline in cerebrospinal fluid amyloid-beta levels

研究概览

简要总结

Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to Screening and remain on their stable dose throughout the trial. Subjects will receive placebo or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid biomarkers and cognitive and psychological measures.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

E2609

Experimental

干预措施: E2609 (Drug)

Placebo for E2609

Placebo Comparator

干预措施: Placebo for E2609 (Drug)

结局指标

主要结局

Percent change from baseline in cerebrospinal fluid amyloid-beta levels

时间窗: baseline to 36 hours post-dose

次要结局

  • Incidence of adverse events(8 days)

研究者

发起方
Eisai Inc.
申办方类型
Industry
责任方
Sponsor

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