A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the evaluation of the efficacy and safety of AGE2 on the Mild Cognitive Impairment
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0004574
- Lead Sponsor
- Koreaeundan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Adult men and women aged from 55 t0 85 years old who complain memory loss
2) Those who can decipher Korean
3) CERAD-K memory score decreased from 1.0SD to less than 2.0SD compare to the same age and education level gruop (CERAD word list memory or word delayed recall or word recognition)
4) A person who agrees to participate in the test and has signed an informed consent form
1) A person who is admitted to hospital with malignant tumor, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe heart disease (unstable angina, myocardial infarction, arrhythmia requiring heart failure treatment) or 3 months after discharge
2) A person with disease causing cognitive impairment such as dementia, Parkinson's disease,cerebral infarction etc.
3) A person who has experience of administering drugs (antipsychotic drugs, degenerative disease agents, brain function improvers, tricyclic antidepressants) for dementia or other cognitive dysfunction within 4 weeks
4) A person whose daily dose of vitamin E preparation is 400 IU or more, or whose dosage decreasing is inevitable.
5) A person who have received estrogen replacement therapy (excluding topical application agents) within 2 months of the start of the test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alzheimer’s Disease Assessment Scale-Korean version-Cognitive subscale total score
- Secondary Outcome Measures
Name Time Method Alzheimer’s Disease Assessment Scale-Korean version-Cognitive subscale memory score