Person with normal cognitive function or equivalent to mild cognitive impairment
Conditions
Interventions
Subjects will take SIC_02301-containing food or placebo food once a day or 104 weeks. The intake period may be terminated earlier based on the results of interim analysis at 52 weeks.
Sponsors
Nagashima Hirotaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects aged 65 to 80 at the time of obtaining consent - Those who scored 24 or more on the Mini Mental State Examination-Japanese at the time of the eligibility test. - Subjects whose score 29 or less on the Japanese version of the Montreal Cognitive Assessment at the screening test. - Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: -Subjects who are under medication for dementia, Alzheimer's disease, psychiatric and cerebrovascular disease. -Subjects who have a history of diagnosed with arteriosclerosis, diabetes, vitamin B1 deficiency, renal insufficiency, liver disorder. -Subjects with a history of circulatory disease. -Subjects who have indicated ECG abnormalities previously. -Subjects who have indicated abnormal tumor marker values previously. -Subjects who have indicated cognitive dysfunction to the extent that it interferes with daily life previously. -Subjects who regularly use pharmaceutivals. However, subjects who meet any of the following criteria may be included, if necessary a. Is taking medications for hypertension or dyslipidemia for which there is no anticipated risk of drug interaction and the symptoms are adequately controlled b. Is using eye drops or topical medications that do not pose a potential drug interaction risk -Subjects who fall under any of the following a. Excessive smoker (average of 21 cigarettes or more per day) b. Consuming excessive amounts of alcohol (more than 60 g of pure alcohol on average per day) -Subjects with impaired motor function that interferes with daily living. -Subjects who are considered to have difficulty maintaining their health during the study period. -Those who plan to make changes* in their daily lifestyle to a degree that will affect the evaluation of this study. *Specific examples: Intend to take new health foods specified in the "Prohibited concomitant medications" section of the research protocol, intend to drastically change his/her sleeping habits, or intend to change his/her exercise habits such as starting a new high-intensity exercise program. -Subjects who have difficulty drawing blood from a peripheral vein. -Subjects who have difficulty in answering the questionnaires used in the study and who meet any of the following conditions a. Subjects who have difficulties in recognition of colors. b. Subjects whose visual acuity is too low to perform test although correction using glasses. c. Subjects whose hearing acuity is too low to perform test although correction using hearing aid. d. Subjects who difficulty reading, writing, or speaking Japanese e. Subjects who cannot recognize Arabic numerals -Subjects who fall under any of the following with regard to blood sampling history. [male and female] a. Subjects who have experienced sickness or deterioration of physical condition due to blood collection in the past. b. Subjects who have had a component blood donation or a whole blood donation of 200 mL or more drawn within 4 weeks prior to screening test. [male] c. Subjects who have donated at least 400 mL of whole blood drawn within 12 weeks prior to screening test. d. Subjects whose blood collection within 52 weeks prior to the screening test, plus the total planned blood collection for this study exceeds 1200 mL. [female] e. Subjects who have donated at least 400 mL of whole blood drawn within 16 weeks prior to screening test. f. Subjects whose blood collection within 52 weeks prior to the screening test, plus the total planned blood collection for this study exceeds 800 mL. -Subjects whose systolic blood pressure is less
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in composite score of cognitive function after 104 weeks of study food intake | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in composite score by cognitive function domain - Change in score for each test used for the composite score of cognitive function | — |
Contacts
Public ContactKeiko Watabe
Medical Corporation Chisei-kai Tokyo Center Clinic
Outcome results
None listed