mild cognitive impairment, Alzheimers disease mild cognitive impairment, Alzheimers disease, dementia
Conditions
Interventions
prebiotics
Sponsors
Yamashiro Kazuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with MCI (CDR 0.5) or early AD (CDR 1) 2) Patients who are over 60 years old and under 90 years old at the time of obtaining consent 3) Outpatient 4) Patients who have the capacity to consent and are able to obtain written consent of their own free will, or patients whose legal guardian can provide written consent if consent is difficult to obtain due to dementia. 5) Patients who are judged by the principal investigator (sub-researcher) to be able to appropriately evaluate the efficacy and safety of this study after considering the inclusion and exclusion criteria.
Exclusion criteria
Exclusion criteria: 1) Those who regularly use foods for specified health uses, foods with functional claims, or health foods (including supplements) three or more times a week that may affect the study, and cannot stop using them within two weeks before the start of the study. 2) Those who are taking medicines that may affect the research (specific examples: antibiotics, intestinal medicines) and cannot restrict their intake during the research period. 3) Heavy alcohol drinkers with an average daily alcohol intake of more than 60 grams for one week (The amount of alcohol equivalent to 20g of alcohol is one 500ml can of beer, one cup of Japanese sake, and just under two glasses of wine). 4) Persons with serious heart disease. 5) Persons with serious renal disease (serum creatinine level 2.0 mg/dL or higher). 6) Persons with severe liver damage (AST or ALT 100 U/L or more). 7) Those who are participating in clinical research on other drugs or health foods, within 4 weeks after the end of the research, or who plan to participate in other clinical research after consenting to participate in the research. 8) Persons who are judged to be inappropriate for participation in this study by the principal investigator or co-research physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Brain diffusion MRI FW value from baseline (start of treatment) to final evaluation (week 24 of administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| Chenges in cognitive function tests (MMSE, MoCA, ADAS-cog) (24 weeks of administration) Changes in gut microbiota composition (24 weeks of administration) Changes in fecal short-chain fatty acid concentration (24 weeks of administration) Changes in inflammatory markers (hs-CRP, IL-6, IL-1b, TNFa) (24 weeks of administration) | — |
Contacts
Public ContactKazuo Yamashiro
Juntendo University Urayasu Hospital
Outcome results
None listed