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临床试验/JPRN-UMIN000020894
JPRN-UMIN000020894进行中(未招募)未知

Effect of supplement involved ferulic acid, glycerophosphocholine and ginkgo leaf extract on mild cognitive impairment. -A randomized, double-blind, placebo-controlled, parallel-group clinical trial

FANCL Corporation Research Institute0 个研究点目标入组 60 人开始时间: 2016年2月5日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
60

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
65years-old 至 ot applicable(—)
性别
All

入选标准

  • 1 Subjects with MCI and who meet the following criteria
  • Amnestic MCI
  • CDR 0 or 0.5
  • MMSE 22-26 and/or ADAS-jcog 5-15
  • 2 Subjects who giving written informed consent

排除标准

  • 1) Subjects who use or plan to use go drugs affecting cognitive function or dementia.
  • 2) Subjects who constantly use Kampo preparation affecting cognitive function or dementia.
  • 3) Subjects who constantly use functional supplement affecting cognitive function or dementia.
  • 4) Subjects who have psychiatric disorder (schizophrenia, mania, depression, severe cardiopathy, delirium, alcoholism etc.) affecting cognitive function or dementia with the exception of complete remission.
  • 5) Subjects who take medical treatment for psychoneurosis (confusion, hallucination, delusion, abnormal behavior etc.) with antipsychotic drug.
  • 6) Subjects with metabolic disease (hypothyroidism, deficiency of vitamin B12, etc.) affecting cognitive function or dementia.
  • 7) Subjects with liver disease, renal disease or hypoactivity of renal function (eGFR<=20 mL/min).
  • 8) Subjects with type 2 diabetes and HbA1c>8.4%, insulin treatment or taking drug for insulin secretion accelerating agent.
  • 9) Subjects with chronic obstructive lung disease (COPD) and oxygen therapy in home or FEV1<30%.
  • 10) Subjects with essential hypertension or uncontrolled hyperlipidemia.
  • 11) Subjects who have medical history of gastrointestinal surgery or hospitalization for head injury within 10 years.
  • 12) Subjects who have history of intracerebral hemorrhage, subarachnoid hemorrhage, cardiac hypertrophy?cardiac failure, ischemic heart disease(IHD), nephrosclerosis, aortic dissection, cerebral infarction.
  • 13) Subjects who take medical treatment for cancer.
  • 14) Subjects who are planned to participate in other clinical study.
  • 15) Subjects who are judged as unsuitable for the study by the investigator for other reason.

研究者

发起方
FANCL Corporation Research Institute

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