None listed
Conditions
Interventions
Others(Health Functional Food) : SH_Cog(aGPC) 600 mg is taken orally once a day, 2 capsules at a time for 12 weeks
Sponsors
Yonsei University Yongin Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) ADAS-cog total score;2) ADAS-cog memory domain score;3) ADAS-cog 11 items + ADAS-noncog concentration 1 item;4) MoCA-K;5) Visual C.P.T;6) K-CWST;7) S-IADL;8) SCD-Q;9) SGDS-K | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Adverse reactions;2) Clinical pathology test (hematologic/hematochemical test, urine test;3) Vital signs (blood pressure, pulse), body measurements (weight) | — |
Countries
Korea, Republic of
Contacts
Public ContactWoo Jung Kim
Yonsei University Yongin Severance Hospital
Outcome results
None listed