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Clinical trial for the evaluation of the efficacy and safety of Aminothioneine on the improvement of memory management

A 12 week, randomized, double-blind, placebo-controlled, parallel design clinical trial for the evaluation of the efficacy and safety of Aminothioneine on the improvement of memory management

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009425
Enrollment
100
Registered
2024-05-10
Start date
2023-02-13
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Test food: Take Aminothioneine capsule 800mg/day(400mg/capsule, 500mg/day as an Aminothioneine) orally once daily, 2 capsules per day, 12 weeks Contrast food: Take placebo 800mg/d

Sponsors

Daedong Korea Ginseng
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Korean Version of Montreal Cognitive Assessment (MoCA-K)

Secondary

MeasureTime frame
Verbal Learning Test, Visual CPT, Digit Span Test in Computerzied NeuroCognitive Function test;Score of Subjective Memory Complaints Questionnaire;Serum BDNF(ng/ml)

Countries

Korea, Republic of

Contacts

Public ContactSeungHo Ryu

Konkuk University Medical Center

shryu.md@gmail.com+82-2-2030-7567

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026