Human clinical trial to evaluate the effectiveness and safety of SH_CAPK08 on cognitive function improvement in mild cognitive impairment
- Conditions
- Not Applicable
- Registration Number
- KCT0008797
- Lead Sponsor
- Yonsei University Yongin Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Men and women aged 55 years or older and younger than 85 years old
2) Those who can read Korean
3) Those who showed decrease in CERAD-K memory(CERAD Word List Memory or Word List Recall OR Word List) score OR SVLT of SNSB score by 1.0 SD or more when compared with the same education level and age group;
4) Those who agree to participate in this human application test before the human application test begins, and submit a written
Those who completed the Informed Consent Form
1) Severe immune system, respiratory system, gastrointestinal/liver and biliary tract, kidney and urinary system, nervous system,
Those currently undergoing treatment for musculoskeletal system, infectious diseases and malignant tumors (but, human application test
It is possible to participate in the test according to the judgment of the tester in consideration of the subject's condition.)
2) Current mental illness such as depression (based on DSM-V), schizophrenia, alcoholism, or drug dependence
person with
3) Those with diseases accompanied by cognitive decline such as dementia (based on DSM-V) and Parkinson's
4) Head trauma with loss of consciousness within 6 months from visit 1, cardiovascular cerebrovascular
Those with a history of disease (angina pectoris, myocardial infarction, transient ischemic attack, acute stroke, etc.)
5) Drugs that affect cognitive function within 4 weeks from visit 1 (antipsychotics, degenerative drugs)
Those who have administered drugs for diseases, brain function improvers, tricyclic antidepressants)
6) If the daily dose of vitamin E is 400 IU or more or it is impossible to reduce the dose
expected person
7) Estrogen replacement therapy (topical application) within 2 months of visit 1
Excluding) who have experience administering
8) Those who have taken health functional foods related to cognitive function improvement within 2 weeks of visit 1
9) Thyroid disease patients with TSH below 0.1 µIU/mL or above 10 µIU/mL
10) A person whose creatinine is more than twice the upper limit of normal at the implementing institution
11) A person whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of normal
12) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure 100 mmHg or more, measurement standard after resting for 10 minutes for human subjects)
13) Diabetes patients with uncontrolled blood sugar (fasting blood sugar of 180 mg/dL or higher)
14) Those who are sensitive or allergic to food ingredients for this human application test
15) Pregnant or lactating women or those who plan to become pregnant during this human application test
16) Other interventional clinical trials (including human application trials) within 3 months of visit 1 Participated in, or other interventional clinical trials (human application trials) after the start of this human application trial(including) who plan to participate in
17) Those who are judged inappropriate for this human application test by the tester
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method