Cerebral microbleeds, cerebral small vessel disease, vascular cognitive impairment Cerebral microbleeds, cerebral small vessel disease, vascular cognitive impairment
Conditions
Interventions
Oral intake of tablets containing anti-Streptococcus mutans IgY antibody, 52 weeks
Tablets containing anti-S. mutans IgY antibody
Sponsors
Ihara Masafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients between 40 and 92 years of age at the time of consent 2) Patients known to harbor Cnm protein-positive S. mutans in the oral cavity 3) Patients who have at least 1 CMBs on a T2*-weighted brain MRI taken within 365 days prior to the date of consent 4) Patients who provide written consent
Exclusion criteria
Exclusion criteria: 1) Patients who cannot undergo brain MRI due to metal implants in the body (e.g., pacemakers) 2) Patients with no remaining teeth 3) Patients with hemorrhagic factors 4) Patients who cannot undergo cognitive function tests 5) Patients diagnosed with secondary cognitive impairment (Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple system atrophy, multiple sclerosis, permanent head injury, neurosyphilis, hypothyroidism, vitamin B1/12 deficiency, and folic acid deficiency) 6) Patients who take antiboitics or immnosuppresants over 3 months prior to informed consent 7) Patients with egg allergy 8) Patients diagnosed with cancer within 5 years prior to obtaining consent 9) Pregnant or lactating women or patients who cannot consent to contraception during study participation 10) Patients who are already participating in other clinical trials or will be participating during the study period 11) Patients deemed unsuitable for enrolment by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Newly developed CMBs after 52-week intake of the trial drugs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Increase in the number of CMBs after 52-week intake of the trial drugs 2) Changes in white matter hyperintensity on brain MRI after 52-week intake of the trial drugs 3) Presence and number of new onset of lacunes on brain MRI after 52-week intake of the trial drugs 4) Presence and number of new perivascular spaces on brain MRI after 52-week intake of the trial drugs 5) Changes in cognitive function (MoCA, and trail making test) after 52-week intake of the trial drugs 6) Symptomatic ischemic or hemorrhagic stroke 7) Correlation between the changes of S. mutans amount and brain MRI findings | — |
Contacts
Public ContactYorito Hattori
National Cerebral and Cardiovascular Center
Outcome results
None listed