Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese men and women aged 50 to 69 years at the time of informed consent 2) Those who are aware of cognitive decline 3) Persons able to take one capsule daily for 12 weeks 4)Persons with an M MMSE score of 24 or more 5) Non smoker 6) A person who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Exclusion criteria
Exclusion criteria: 1) Subjects who are currently receiving any medications or outpatient treatment. 2) History of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease Or those with a merger 3) Patients with a history of drug or food allergy 4) People who use health foods and supplements that may affect cognitive function 5) Persons using drugs that may affect cognitive function 6) Persons with extreme skipped eating 7) Excessively irregular lifestyle such as eating or sleeping 8) Patients suspected of having insomnia (insomnia, sleep apnea syndrome, etc.) 9) Persons with a current or past history of psychiatric disorders (depression, etc.) 10) Persons with a current or past history of alcoholism 11) Subjects who have participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period. 12) Persons whose working hours are irregular, such as those who have worked at night. 13) Subjects who are pregnant, breast-feeding, or willing to become pregnant during the study period 14) Persons who are difficult to comply with the records of various surveys 15) Other than the above, the principal investigator judged that the subject was ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax,MMSE | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, Blood BDNF, Blood Abeta (1-40, 1-42, oligomers), Blood sAPP alpha, MicroRNAs | — |
Countries
Japan
Contacts
Public ContactOchitani Daisuke
HUMA R&D CORP Clinical Development Division
Outcome results
None listed