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临床试验/KCT0009187
KCT0009187已完成Unknown

A 12 Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of NVP-2106 on improvement of Cognitive Function

VP Healthcare0 个研究点目标入组 120 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
120

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
60(Year) 至 74(Year)(—)
性别
All

入选标准

  • 1) Adult men and women who are 60 years of age or older at the time of screening and complain of memory decline
  • 2) Those whose CERAD-K word list memory/recall/recognition test score decreased by 1-2 SD from the normal value (those who satisfy at least 1 of the 3 items above)
  • 3) Those with a total score of 22 or less on the Korean version of the Montreal Cognitive Assessment (MOCA-K)
  • 4) A person who, after hearing and fully understanding the detailed explanation of this human application test, voluntarily decides to participate and agrees in writing to comply with the precautions

排除标准

  • 1) Those who are currently treated with DSM-IV Axis I Disorders in Structured Clinical Interview for DSM-IV (SCID) conducted at the time of the screening test or have a history of being treated within the last three years.
  • 2) A person who has continuously consumed lactobacillus formulation (or probiotic formulation) and fermented dairy products (yogurt, cheese, etc.) within 2 weeks prior to the screening test (four times or more/week).
  • 3) A person who has alcohol abuse or dependence within three months prior to a screening test.
  • 4) Those with clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatometer, kidney and urinary system, neuropsychiatric system, musculoskeletal system, inflammatory and blood and oncogenic, gastrointestinal disease, etc. that require treatment.
  • 5) A person who has taken drugs, health functional foods or herbal medicines related to cognitive and memory improvement within one month prior to a screening test (see prohibited drugs).
  • 6) A person who has taken psychiatric drugs such as antipsychotic drugs, antidepressants, mood control agents, sleeping pills, and anti-anxiety drugs within one month prior to a screening test.
  • 7) Those who have taken antibiotics within four weeks prior to a screening test.
  • 8) A person who has donated whole blood within one month before the screening test or donated ingredients within two weeks.
  • 9) A person who has participated in another human body application test within three months prior to the screening test.
  • 10) Those who show the following results in diagnostic tests and medical tests.
  • ? AST, ALT > 3 times the upper limit of the reference range
  • ? Serum Creatinine > 2.0 mg/dL
  • 11) A person who determines that the examiner is unfit to participate in the study due to other reasons, including the results of diagnostic tests and medical tests.

研究者

发起方
VP Healthcare

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