Healthy adults
Conditions
Sponsors
others
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females aged of 50 and 80 at the time of written consent. 2. Subjects who are aware of cognitive decline. 3. Subjects who get 24 or more in score of MMSE-J , 17 or more in score of Moca-J and 5 or less in score of GDS-SF on the SCR test. 4. Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who have been diagnosed with dementia by a physician. 2. Subjects who have taken drugs for dementia, brain metabolism enhancers, thyroid hormones, central nervous system stimulants, antipsychotics, or anticholinergics within 4 weeks prior to the date consent was obtained. 3. Subjects with the following abnormal findings in clinical laboratory values at the time of SCR. ALT and AST are more than 3 times the upper limit of normal. Hemoglobin less than 8 g/dL or platelet count less than 100,000/microliter. 4. eGFR less than 60 mL/min/1.73m2. 5. Subjects with cognitive impairment due to brain disease or psychiatric disease. 6. Subjects with thyroid-stimulating hormone (TSH) levels outside the normal range. 7. Subjects with serious mental illnesses such as severe depression, schizophrenia, alcoholism, drug addiction, etc. 8. Subjects with a history of angina pectoris, myocardial infarction, transient ischemic attack, or coronary angioplasty including coronary artery bypass surgery within 6 months prior to the date of obtaining consent. 9. Subjects with a history of severe head injury with loss of consciousness within 6 months of the date of consent. 10. Subjects with a history of acute stroke within 3 months of the date of consent. 11. Have a current or previous history of a serious illness other than those listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) MoCa-J,SF-36,WHO-5,BDNF (Safety evaluation) Vital signs, body measurements(weight,BMI),blood biochemistry, hematology, adverse events | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
M&I Science CORP. Clinical Development Department
Outcome results
None listed