A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MPCO on Mild Cognitive Impairment
- Conditions
- Not Applicable
- Registration Number
- KCT0008219
- Lead Sponsor
- INE B
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 150
1) Men and women over 55 years old and under 85 years old
2) Those who can read Korean
3) A person whose memory score on CERAD-K decreased by more than 1.0 SD compared to the same education level and age group
4) A person who agreed to participate in this human application test before the human application test started and filled out the informed consent form
1) Those currently undergoing treatment for severe immune system, respiratory system, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious diseases and malignant tumors You can participate at your discretion.)
2) Persons with mental illness such as depression, schizophrenia, alcoholism, drug dependence, etc.
3) Those with diseases accompanied by cognitive decline, such as dementia or Parkinson's
4) Those with a history of head trauma accompanied by loss of consciousness, cardiovascular disease (angina pectoris, myocardial infarction, transient ischemic attack, acute stroke, etc.) within 6 months of visit 1
5) Persons who have received estrogen replacement therapy within 2 months of visit 1
6) Those who have administered drugs (antipsychotics, drugs for degenerative diseases, brain function improvers, tricyclic antidepressants) that affect cognitive function within 4 weeks of visit 1
7) Those who have taken health functional foods related to cognitive function improvement within 2 weeks of visit 1
8) A person whose daily dose of vitamin E preparation is 400 IU or more or who is expected to not be able to reduce the dose
9) Thyroid disease patients with TSH of 0.1 or less or 10 or more
10) A person whose creatinine is twice the upper limit of normal at the implementing institution
11) A person whose AST or ALT is more than three times the upper limit of the implementing agency
12) Patients with uncontrolled hypertension
13) Patients with uncontrolled diabetes
14) Pregnant or lactating women or those who plan to become pregnant during this human application test
15) Those who are sensitive or allergic to food ingredients for this human application test
16) Those who have participated in other interventional clinical trials within 3 months of the start of this human application trial, or plan to participate in other interventional clinical trials after the start of this human application trial
17) Those who are judged unsuitable by the tester for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ADAS-cog 11 total score; ADAS-cog 13 memory domain score; ADAS-cog 13 total and subscores; Visual C.P.T (visual continuous test);ADCS-ADL (Acts of Daily Living Assessment); SGDS-K (Geriatric Depression Scale)
- Secondary Outcome Measures
Name Time Method body measurements (weight); Vital signs (blood pressure, pulse);Clinical pathology test; Pregnancy test