Effect of PM-EE on the Mild cognitive decline for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003418
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change of total score of ADAS-cog(Cognitive subscale of the ADAS) from baseline to 12 weeks later
- Secondary Outcome Measures
Name Time Method change of memory of ADAS-cog(Cognitive subscale of the ADAS) from baseline to 12 weeks later;change of total score of ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version) from baseline to 12 weeks later;change of the score of K-CWST(Korean-Color Word Stroop Test) from baseline to 12 weeks later;change of total score of SGDS(Short form of Geriatric Depression Scale) from baseline to 12 weeks later;change of total score of ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living) from baseline to 12 weeks later