Mild Cognitive Impairment
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged 55 to 74 years old at the time of the informed consent. 2. Subject who agree with the criterion of the mild cognitive impairment by a DSM-5. 3. MMSE score is more than 24 less than 27 at the time of before ingestion. 4. Z-score using the VSRAD is less than 1.0 on head MRI.image. 5. Subject who has an informant who understands the daily living condition of the person under test 6. Subjects and informants who giving written informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects who constantly use Kampo preparation affecting cognitive function or dementia. 2) Subjects who constantly use supplements preparation affecting cognitive function or dementia. 3) Subjects who have psychiatric disorder affecting cognitive function or dementia with the exception of complete remission. 4)Subjects who take medical treatment for psychoneurosiswith antipsychotic drug. 5) Subjects with metabolic disease affecting cognitive function or dementia. 6) Subjects with liver disease, renal disease or hypoactivity of renal function (eGFR<=20 mL/min). 7) Subjects with uncontrolled type 2 diabetes or received insulin treatment. 8) Subjects with chronic obstructive lung disease and oxygen therapy in home or FEV1<30%. 9) Subjects with essential hypertension or uncontrolled hyperlipidemia. 10) Subjects who have medical history of gastrointestinal surgery or hospitalization for head injury within 10 years. 11) Subjects who have history of intracerebral hemorrhage, subarachnoid hemorrhage, cardiac hypertrophy, cardiac failure, ischemic heart disease, nephrosclerosis, aortic dissection or cerebral infarction. 12) Subjects with structural diseases with a possibility related to recognition dysfunction in the head MRI image acquired within 1 year before agreement acquisition or the first time check point. 13) Subjects who take medical treatment for cancer. 14) Subjects who are planned to participate in other clinical study. 15) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MMSE (0day,90days and 180 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| ABC dementia scale POMS2 Blood apolipoprotein E (0day,90days and 180 days) | — |
Countries
Japan
Contacts
Mebix, Inc Research Promotion Head Office