Clinical trial for evaluation of efficacy on cognitive function of MT104
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0006499
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 86
1) Subjects of 50 to 80 years of age
2) Subjects with mild cognitive impairment
- subjects or guardian claim cognitive impairment
- subjects with decreased verbal or visual memory score of SNSB test below -1SD
3) Subjects who consent participation of study and write written consent
1) Subjects who experienced allergy or adverse events when administered functional food or drugs
2) Subjects who diagnosed with dementia, brain tumor, hydrocephalus
3) Subjects with gastrointestinal disturbance, or have psychiatric disorders (schizophrenia, epilepsy, alcohol intoxication, anorexia, abnormally increased appetite
4) Subjects with stroke, heart disease (heart failure, angina pectoris, myocardial infarction), malignancy, narrow angle glaucoma, uncontrolled hypertension (blood pressure over 60/100mmHg), or pulmanary diseases
5) Subjects with severe renal diseases or hepatic diseases (serum creatinine> 2.0 mg/dl, ALT, AST, alkaline phosphatase> normal upper limit x 2.5)
6) Subjects with uncontrolled blood glucose with hypoglycemic drugs (fasting blood glucose over160mg/dL), platelet (under 150,000/mm3) hemoglobin (male 9.5g/dL, female 9.0g/dL)
7) Subjects who treated with oral steroids, thyroid hormones or administered drugs or functional food which can change absorption, metabolism, and excretion of test food, or subjects who participated with other clinical trial within 3 month
8) Subjects who undergo surgery within 6 month or treated with prohibited treatment (acupuncture or treatment & functional food for brain function or drugs with abuse potential)
9) Subjects who undergo stomach resection or surgery which can influence drug absorption
10) pregnant woman, lactating woman, or fertile woman who do not consent proper contraception (oral contraceptive agent, hormone, uterine device, spermicide)
11) Subjects who donate blood with in 2 month or donate blood fraction within 1 month
12) Subjects who cannot participate in the study by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement rate of total score of K-MMSE
- Secondary Outcome Measures
Name Time Method Improvement rate of total score of K-MoCA;Improvement rate of Seoul Verbal Learning Test (SVLT) score ;Improvement rate of Rey Complex Figure Test (RCFT) score ;Improvement rate of SVLT (immediate recall, recognition) score ;Improvement rate of RCFT (immediate recall, recognition) score