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  • Status : Approved
    • First Submitted Date : 2018/09/13
    • Registered Date : 2019/01/10
    • Last Updated Date : 2018/11/05
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1. Background

Background Information
CRIS
Registration Number
KCT0003418 
Unique Protocol ID 1711-092-901 
Public/Brief Title Effect of PM-EE on the Mild cognitive decline for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial 
Scientific Title Effect of PM-EE on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial  
Acronym PHE_PM-EE 
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number H-1711-092-901 
Approval Date 2018-01-25 
Institutional Review Board  
Name IRB(Institutional Review Board) 
Address 103, Daehak-ro, Jongno-gu, Seoul 
Telephone 02-2072-0694 
Data Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Manho Kim 
Title MD.PhD 
Telephone +82-2-2072-2193 
Affiliation Seoul National University Hospital 
Address 101 Daehakro, Jongnogu, Seoul 030 
Contact Person for Public Queries
Name JIYOUNG SHIM 
Title CRC 
Telephone +82-2-2072-2193 
Affiliation Seoul National University Hospital 
Address 101 Daehakro, Jongnogu, Seoul 030 
Contact Person for Updating Information
Name Eunkyung Shin 
Title Researcher 
Telephone +82-2-2072-2193 
Affiliation Seoul National University Hospital 
Address 101 Daehakro, Jongnogu, Seoul 030 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Active, not recruiting  
Date of First Enrollment 2018-03-08 , Actual
Target Number of Participant 60
Primary Completion Date 2018-09-28 , Anticipated
Study Completion Date 2019-01-24 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Seoul National University Hospital 
Recruitment Status Active, not recruiting  
Date of First Enrollment 2018-03-08 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Ministry of Agriculture, Food and Rural Affairs 
Organization Type Government  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Seoul National University Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary This human study is to investigate the effect of PM-EE(SE-EE) intake on improving cognitive function. The mild cognitive decline subjects aged 55 to 85 year are randomly assigned to case and control group, and each group takes PM-EE(SE-EE) or placebo for 12 weeks. Several cognitive and learning abilities are assessed on 0 and 12 weeks to evaluate the efficacy and safety of PM-EE(SE-EE).  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Dietary Supplement  
Intervention Description Eeah group takes either placebo or PM-EE(SE-EE) 2 tablets by mouth twice daily for 12 weeks. The shape and weight of placebo or PM-EE(SE-EE) are same.  
Number of Arms
Arm 1 Arm Label Experimental group 
Target Number of Participant 30 
Arm Type Experimental 
Arm Description Consumption of PM-EE(SE-EE), 2 tablets by mouth twice a day for 12 weeks. (PM-EE 600mg/day) 
Arm 2 Arm Label Control group 
Target Number of Participant 30 
Arm Type Placebo comparator 
Arm Description Consumption of placebo, 2 tablets by mouth twice a day for 12 weeks. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Mental and behavioral disorders
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 55 Year ~ 85 Year
Description 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  
Exclusion Criteria 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  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome change of total score of ADAS-cog(Cognitive subscale of the ADAS) from baseline to 12 weeks later 
Timepoint 0 week, 12 weeks 
Secondary Outcome(s) 1 
Outcome change of memory of ADAS-cog(Cognitive subscale of the ADAS) from baseline to 12 weeks later 
Timepoint 0 week, 12 weeks 
Secondary Outcome(s) 2 
Outcome change of total score of ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version) from baseline to 12 weeks later 
Timepoint 0 week, 12 weeks 
Secondary Outcome(s) 3 
Outcome change of the score of K-CWST(Korean-Color Word Stroop Test) from baseline to 12 weeks later 
Timepoint 0 week, 12 weeks 
Secondary Outcome(s) 4 
Outcome change of total score of SGDS(Short form of Geriatric Depression Scale) from baseline to 12 weeks later 
Timepoint 0 week, 12 weeks 
Secondary Outcome(s) 5 
Outcome change of total score of ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living) from baseline to 12 weeks later 
Timepoint 0 week, 12 weeks 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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