Clinical trial for the evaluation of the efficacy and safety of Aminothioneine on the improvement of memory management
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0009425
- Lead Sponsor
- Daedong Korea Ginseng
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Males and females who are at least 50 years of age and less than 75 years of age (non-pregnant women)
2. Subjects who have at least one year of elementary school education
3. A standardized score of less than -1.0 on at least one of the Word List Memory Test, Word List Recall Test or Word List Retrieval Test of the CERAD-K test when compared with subjects of the same gender, age group and educational level
4. Subjects who decide to participate in this study and give written informed consent
1. Subjects with a history of drug hypersensitivity reactions to medicines, food ingreientsm herbal extracts, herbal medicines, dietary supplements, etc.
2. Subjects who have taken any memory-enhancing medicines(dementia medications, brain metabolism enhancers, thyroid hormones, central nervous system stimulants, antipsychotics, anticholinergics), foods, supplments, ergothioneine, etc. within 4 weeks prior to screening
3. Subjects who take medications such as antihistamines, non-steroidal anti-inflammatory drugs, hormones, antibiotics, etc.
4. Subjects who have difficutly communicating on a daily basis due to impairments such as vision or hearing or have difficulty writing due to physical disabilities
5. Subjects who have a neurodegenerative disease(dementia, Parkinson's disease, etc.) that affects memory(diagnosis is based on DSM-V)
6. Subjects who diagnosed physical illnesses such as head trauma, stroke, etc.
7. Subjects who diagnosed and being treated for a serious medical condition such as cerebrovascular disease, lung disease, epilepsy, intellectual disability, neurological disease, endocrine disease, haematological/malignant tumours, cardiovasular disease, Crohn's disease, etc.
8. Subjects who have a serve mental illness such as depression, schizophrenia, anxiety disorder, or are addicted to drugs or alcohol
9. Subjects with history of malignancy, unstable angina pectoris, myocardial infarction, transient ischaemic attack, coronary intervention including coronary artery bypass grafting within 6 months of the screening
10. Subjects who have neurological surgery or surgery involving the brain wihtin 6 months of screening
11. Subjects who have TSH less than equal to 0.1 µU/mL, or thyroid disease greater than or equal to 10 µU/mL
12. Uncontrolled hypertension (blood pressure = 160/100 mmHg)
13. Uncontrolled glycaemia (fasting blood glucose = 180 mg/dL or new initiation of medication for diabetes within 3 months of screening)
14. Subjects who have liver disease or ALT, AST > 3 times the upper limit of normal for the site
15. Subjects with renal disease or Creatinine greater than 2 times the upper limit of normal for the site
16. Subjects who participated in another clinical trial within 3 months of screening
17. Subjects who, in the judgement of the investigator, is deemed unsuitable for participation in this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Korean Version of Montreal Cognitive Assessment (MoCA-K)
- Secondary Outcome Measures
Name Time Method Verbal Learning Test, Visual CPT, Digit Span Test in Computerzied NeuroCognitive Function test;Score of Subjective Memory Complaints Questionnaire;Serum BDNF(ng/ml)