Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age:50 and over, below 80. 2) Sex:Males and females with Japanese nationality. 3) Subjects whose MMSE score is 22 to 27.
Exclusion criteria
Exclusion criteria: 1) Subjects who are under medication or treatment for serious disease. 2) Subjects who are under diet therapy and exercise therapy in the control of doctor. 3) Subjects with a history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological and metabolic diseases or those who undertake medication or treatment for such disease. 4) Subjects having a history of major surgery involving gastrectomy, gastrointestinal suture surgery, bowel resection, digestive system etc. (except fo rappendicitis) 5) Subjects with a current or past history of psychiatric disorders. 6) Subjects with a current or past history of drug or food allergy. 7) Subjects who are diagnosed as dementia. 8) Subjects who are receiving or have a history of drug dependence or drug abuse. 9) Subjects who have participated in other clinical tests within the past one months. 10) Subjects with irregular working hours, such as night shifts. 11) Subjects with a current or past history of alcoholism. 12) Subjects who were judged inadequate by investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RBANS MMSE | — |
Secondary
| Measure | Time frame |
|---|---|
| POMS2(Short Form) Patient Health Questionnaire-9 (PHQ-9) | — |
Countries
Japan
Contacts
Public ContactMatsuoka Masao
HUMA R&D CORP Clinical Development Division
Outcome results
None listed