Effect of PM-EE on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Seoul National University Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1) Having complaint of memory loss in aged 55~85 years
•2) Literate
•3) Korean version of the consortium to establish a Registry for Alzheimer’s Disease(CERAD-K) Word list memory or Word delayed recall or Word recognition is decreased 1.0SD ~ 1.5SD
•4) Agree to Informed consent

•Having history of
•1) malignant tumor or severe cerebrovascular disease or severe heart disease
•2) schizophrenia
•3) major depressive disorder according to DSM-V(The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
•4) cognitive disorder based on DSM-V (e.g. dementia, Parkinson's disease, cerebral infarction)
•5) in 4 weeks prior to this study, the medication related to congnitive disorder intake
•6) Vitamin E over 400 IU contained drug intake
•7) in 2 months prior to this study, Estrogen replacement therapy was received
•8) in 2 weeks prior to this study, the dietary supplement related to enhance congnitive function intake
•9) alcohol abuse
•10) thyroid stimulation hormon (TSH) was decreased under 0.1 uIU/ml or increased over 10 uIU/ml
•11) creatinine level was increased over two times of the upper limit
•12) AST(GOT) and/or ALT(GPT) was increased over three times of the upper limit
•13) uncontrolled hypertension
•14) uncontrolled DM
•15) In 3 months prior or after this study, involvement to other clinical trial
•16) being determined to be inappropriate

发起方