Mild cognitive impairment
Conditions
Interventions
Patients will be randomized 1:1 to either the taxifolin pretreatment group or the placebo pretreatment group. The taxifolin pre-treatment group will then receive 100 mg taxifolin capsules orally once
Sponsors
Hattori Yorito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 40 years or older and less than 90 years 2) Patients who have 0.5 or 1 point in clinical dementia rating (CDR) global score at screening period 3) Patients who do not have symptomatic hemorrhagic/ischemic stroke, acute ischemic stroke, brain tumor, or severe stenosis/occlusion of middle cerebral artery in brain MRI taken within 48 weeks prior to the date of consent 4) Patients or proxies who provide written consent
Exclusion criteria
Exclusion criteria: 1) Severely demented patients who fail to undergo neuropsychological examinations 2) Patients already diagnosed with secondary dementia (Parkinson disease, Parkinsons syndrome, Huntington disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple system atrophy, multiple sclerosis, head injury with sequelae, neurosyphilis, hypothyroidism, vitamin B1/12 deficiency, and folic acid deficiency) 3) Patients who did not cease the intake of taxifolin at least 6 weeks prior to the administration of the experimental drugs if the patients already consume taxifolin. 4) Patients who are treated by lecanemab or donanemab 5) Patients with a history of dose change in donepezil, galantamine, rivastigmine, or memantine within 4 weeks before obtaining informed consent 6) Patients with a past history of intrinsic psychiatric disease or alcohol or drug dependence within 48 weeks before giving their informed consent 7) Patients with serious uncontrolled systemic diseases (heart failure, liver failure, renal failure, hypothyroidism, etc.) 8) Patients who suffer from gelatin allergy 9) Patients who experienced malignancy within the past 5 years 10) Pregnant and breastfeeding women or patients who do not agree to use appropriate contraception. 11) Patients participating in or planning to participate in other clinical trials using other medicines or medical devices. 12) Patients deemed unsuitable for enrolment by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of MoCA total score from baseline to 12 weeks (extraction) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Improvement of MoCA total score from baseline to 12 weeks 2) Change of Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-Cog) total score from baseline to 12 weeks (extraction) 3) Change of total time in trail-making test J part B from baseline to 12 weeks 4) Volume or grade changes of white matter hyperintensities examined by brain magnetic resonance imaging (MRI) from baseline to 12 weeks 5) Change of the number of cerebral microbleeds in the brain MRI from baseline to 12 weeks 6) Body weight change from baseline to 12 weeks | — |
Contacts
Public ContactManami Fukase
National Cerebral and Cardiovascular Center
Outcome results
None listed