跳至主要内容
临床试验/NCT03369925
NCT03369925已完成不适用

A Parallel, Double-Blind Study to Assess the Cognitive Effects of a Citicoline Supplement (Cognizin®) in Men and Women With Age-Associated Memory Impairment

Kyowa Hakko Bio Co., Ltd.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment

研究概览

简要总结

The objective of this trial is to determine the effects of citicoline on cognitive performance in healthy Men and Women with Age-Associated Memory Impairment compared to a placebo.

详细描述

This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women with Age-Associated Memory Impairment. Cognitive assessments will be performed to determine whether citicoline administration with supportive memory, compared to placebo administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, 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

  • male or female, 50-85 years of age
  • at least a high school diploma or the equivalent
  • self-reported memory loss
  • scores ≥24 on the Mini-Mental State Examination, ≥85 on the Kaufman Brief Intelligence Test, Second Edition, ≤5 on the Geriatric Depression Scale, and 4, 3, or 2 on the Spatial Span Test
  • no health conditions that would prevent him or her from fulfilling the study requirements on the basis of medical history and routine laboratory test results

排除标准

  • color blind
  • abnormal laboratory test results
  • major medical or neurological illness
  • female who is pregnant, planning to be pregnant during the study period
  • requiring treatment with a drug which might obscure the action of the study treatment

研究组 & 干预措施

Cognizin

Experimental

干预措施: Citicoline supplement (Dietary Supplement)

Placebo

Placebo Comparator

干预措施: Placebo supplement (Dietary Supplement)

结局指标

主要结局

Standardized scores on the Cambridge Brain Sciences that measure cognitive assessment

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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