Mild Cognitive Impairment
Conditions
Interventions
Low temperature aged garlic extract (S-allylcysteine 250 microgram/day, 12 weeks)
Placebo (dextrin), 12 weeks
Sponsors
Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) MMSE score before intervention is 24 to 28. (2) Those who can avoid heavy eating/drinking (3) Those who can avoid drinking the day before the test. (4) Those who and his/her proxy agree to participate in this trial in writing, after reading the explanation consent document and receiving explanations. (5) Those who have been judged by a physician to be able to understand the content of this trial and comply with the study protocol. (6) Those who are determined by the examiner to have a high probability to complete the study protocol.
Exclusion criteria
Exclusion criteria: 1. Those who are receiving the medicines that affect the evaluation of this study; i.e. donepezil hydrochloride, galantamine hydrobromide, memantine hydrochloride, rivastigmine, and zonisamide. 2. Those who are taking supplement for improving cognitive function; i.e. ginkgo biloba extract, EPA / DHA, plasmalogen, phosphatidylserine / choline, anthocyanin, GABA, arachidonic acid, seryltyrosine, histidine, ferulic acid, and garden angelica. 3. Those who have history of epilepsy or brain disease. 4. Those who have been diagnosed with a malignant tumor or have a history of severe liver damage, kidney damage or heart disease. 5. Those who consume a large amount of alcohol; i.e. 60g or more of alcohol per day. 6. Those who may develop allergies to test food ingredients. 7. At screening test, the test results are classified as treatment required by the Judgment Categorydetermined by the Japan Medical Dock Association (April 1, 2018 revision, December 14, 2018 partial change). 8. Those who have been judged by a doctor to be unable to complete the study or to have a significant risk to the subject due to abnormal medical or mental conditions. 9. Those who are participting in aother clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function (MMSE): 12 weeks after the start of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of sleep (PSQI, JESS, AIS-J) Health related QOL (SF-36) Blood, urine: 12 weeks after the start of administration | — |
Countries
Japan
Contacts
Public ContactYoshio Suzuki
Juntendo University Graduate School of Health and Sports Science
Outcome results
None listed