Effect of DW2009 on the Mild Cognitive Impairment for the Efficacy and Safety

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

(1)Physically healthy men and women aged between 55 and 85 years old who complain of memory loss
(2)A person who is capable of Korean
(3) A person who complain of memory loss and demonstrate a decrease of 1.0 SD or more on CERAD-K (Consortium to Establish a Registry for Alzheimer's Disease-Korean version)
(4)A person who has agreed to participate in this Clinical trial before signing the human body test and has signed an informed consent

Exclusion Criteria

(1) People who has medical history of malignant tumors, severe cardiovascular diseases (stroke, hemorrhage, etc), and sever heart diseases (angina, myocardial infarction, heart failure, arrhythmias requiring treatments). However, people who have a history of cardiovascular diseases but are clinically stable can participate in the study.
(2) People who are currently suffering from schizophrenia or have a history of schizophrenia
(3) People who have major depressive disorders categorized by DSM-V(The Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition)
(4) People who have poor cognitive function and have Alzheimer’s disease, Parkinson’s disease, or stroke. (The diagnosis of Alzheimer’s disease is based on DSM-V)
(5) People who have taken medications for Alzheimer’s disease or other cognitive function problems within 4 weeks prior to the first visit of the study. The examples of the medications are Antipsycotics, Neurodegenerative Disease Drugs, Nootropics & Neurotonics, and tricyclic antidepressant.
(6) People with a daily intake of more than 400 IU vitamin E
(7) People who have received estrogen replacement therapy within the first two months prior to the first visit of the study
(Except for topical coverage)
(8) People who have taken the purposes of improving cognitive function within the first two weeks prior to the first visit of the study
(9) People with alcohol abuse or alcohol dependence
(10) People with thyroid disease (TSH of 0.1 uU/ml or less, or TSH of 10 uU/ml or higher)
(11) People with renal dysfunction whose creatinine level is more than twice the upper limit of normal range
(12) People with dyshepatia or liver failure whose AST(GOT) or ALT(GPT) level is more than triple times the upper limit of normal range
(13) People with uncontrolled hypertension (160/100 mmHg or higher, After 10 minutes of stabilization, measurements are taken as a reference.)
(14) People with uncontrolled diabetes/blood sugar (fasting glucose of 180 mg/dl or higher)
(15) People who plan to become pregnant during pregnancy or during the Clinical trial period
(16) People who have participated in other clinical trials within the first three months of the study, or who plan to participate in other clinical trials since the start of the study
(17) The person who is deemed inappropriate by the Investigator

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the scores of CNT(Computerized NeuroCognitive Function test) between baseline and after 12 weeks of the treatment

Secondary Outcome Measures

Name	Time	Method
Changes in the scores of NORT(Novel object recognition test) between baseline and after 12 weeks of the treatment ;Changes in the scores of Story recall test between baseline and after 12 weeks of the treatment ;Changes in the scores of PRMQ(Prospective and retrospective memory questionnaire) between baseline and after 6 weeks, 12 weeks of the treatment ;Changes in the scores of PSS(Perceived stress scale) between baseline and after 6 weeks, 12 weeks of the treatment ;Changes in the scores of BDNF(Brain-Derived Neurotrophic Factor) between baseline and after 12 weeks of the treatment ;Changes of fecal microbiota between baseline and after 6 weeks, 12 weeks of the treatment