Mild cognitive impairment (MCI) Pre-MCI
Conditions
Interventions
Ingest of powdered Matcha capsules, 9 capsules a day, for 12 months.
Ingest of placebo capsules, 9 capsules a day, for 12 months.
Sponsors
MCBI Inc.
ITO EN, Ltd. Shimadzu Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female between 60 and 85 years old of MCI or pre-MCI who use Japanese language as their mother tongue. 2) Subjects who have not received treatment for cancer, myocardial infarction, or stroke within the past 5 years. 3) Subjects who do not take drugs to treat dementia (Aricept, Reminyl, Rivastach, Memary). 4) Subjects who do not have atrophy of dementia in MRI image. 5) Subjects who have not done interventions such as exercise intervention and cognitive function training as usually performed in day-care. 6) Subjects who can visit the clinic on appointed days. 7) The cooperation of the study partner can be obtained. Study partners are not changed as much as possible. 8) Subjects who consented to APOE genotype analysis. 9) Subjects who agreed with the purpose and contents of this exam, voluntarily volunteered to participate after fully understanding, and who agreed in writing (Criteria for MCI) Type1: Complaint of memory disturbance from the participant plus approval by the study partner Type2: Memory disturbance approved by the study partner, without the subjective complaint of the participant Note) Exclude cases when only the memory disturbance from the person himself/herself is complained and the study partner does not accept it. (1) MMSE-J 24-30. (2) Scores of Wechsler memory Scale-R logical memory II corrected for education, below the cut-off levels. Education 0-7 years 6 or lower Education 8-15 years 9 or lower Education over 16 years 11or lower (3) CDR 0.5 (Criteria for Pre-MCI) Subjects who are out of MCI's Criteria who are not dementia and who meet the following criteria (1) Have awareness of forgetfulness (subjective cognitive decline, SCD) (2)MMSE-J 27-30, or a subject with either mild hippocampal atrophy by MRI examination or mild rCBF reduction by SPECT examination. (3) CDR 0
Exclusion criteria
Exclusion criteria: 1) Those diagnosed with dementia 2) Those diagnosed with Major depressive disorder (MDD) 3) MMSE-J 24> 4) Subjects who have food allergy (Matcha, green tea allergy). 5) Subjects who underwent surgery for cerebrovascular disease. 6) Subjects who take medicine that may influence the outcome of this study (e.g., antipsychotic drug). 7) Subjects who take foods with function claims that may influence the outcome of this study. 8) Subjects who experienced unpleasant feeling during blood collection. 9) Subjects who have participated in other clinical study within the last 4 weeks. 10) Subjects s who drink more than 7 cups of Matcha per week 11) Subjects who cause physical condition by ingesting caffeine 12) Alcoholism 13) Subjects who have had surgery on the upper gastrointestinal tract. 14) Subjects who are judged unsuitable for participating in this study by doctors. 15) Those who can not agree with the purpose of this test conducted in advance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropsychological test (MoCA-J) and activities of daily living scale (ADCS-MCI-ADL) before ingestion, and after ingestion of Matcha tea or placebo for 6 months and for 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological test (MMSE-J, RBANS, ADAS-Jcog, Cognitrax) The Pittsburgh Sleep Quality Index | — |
Countries
Japan
Contacts
Public ContactKohji Meno
MCBI Inc. Research & Development Department
Outcome results
None listed