None listed
Conditions
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 60 years or older at the time of screening 2. Those who can take oral medication 3. A person who does not have severe hearing, vision, or language impairment that affects the performance and completion of tests such as neuropsychological tests 4. Screening Test Those who do not have alcoholism or other substance abuse status, history of stroke, and evidence of central nervous system disease or damage. 5. A person who agreed to participate in this human application test and filled out the written consent form (Informed Consent Form) before the human application test started 6. Those with cognitive function resistance symptoms confirmed at the baseline visit (MMSE-standardized score of 27 points or less) 7. Patients demonstrating at least one confirmed AD pathology based on phosphorylated tau 217 (pTau217) or amyloid PET positivity
Exclusion criteria
Exclusion criteria: 1. Convulsive (epilepsy), acute brain disease, depressive disorder, bipolar disorder, schizophrenia drug use at the time of screening 2. Those who are taking antibiotics at the time of screening or who are expected to take antibiotics during the human application test period 3. A person who has had food poisoning symptoms within four months at the time of screening or at the time of screening 4. Those who are taking immunosuppressants (Imuran Tab., Cellcept, Genapax Inc.) at the time of screening or who are expected to take them during the human application test period 5. Those who are concerned about lowered immunity under the judgment of the tester during screening 6. Those who are taking mental health-related (depression, alcoholism) drugs for a long time at the time of screening 7. A person who was diagnosed with a disability (blindness in one eye, hearing loss in one ear) at the time of screening 8. Subjects with a history of loss of consciousness due to severe head trauma at the time of screening 9. Cancer patients less than three years after cancer treatment before screening 10. Patients who received metal implants at the time of screening 11. Those who have difficulty stopping taking other probiotics products during screening or those who are expected to take them during the human application test 12. Those who have difficulty stopping taking other brain nutrients and treatment products being taken during screening or those who are expected to take them during the human application test 13. Those who are sensitive or allergic to the food ingredients for this human application test (Lactobacillus brevis KL251, Lactobacillus fermentum KL271, Bifidobacterium lactis KL101 complex) 14. Those who have participated in other interventional clinical trials (including human trials) within three months of screening or plan to participate in other interventional clinical trials (including human trials) after the start of this human trial 15. Those who are judged by the tester to be unsuitable for participation for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 13-item version of the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog 13) total scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini Mental State Examination (extended form) score change;Mini Mental State Examination-2 score change;Change in ADAS-cog 13 sub scores;Clinical Dementia Rating- Sum of Boxes (CDR-SB) score and change;Global Deterioration Scale, Activities of Daily Living, Korean Dementia Screening Questionnaire, Subjective Memory Complaints Questionnaire score and change;Blood biomarkers [NfL, GFAP, CRP, ESR] level and change;Bowel and bowel activity questionnaire scores and changes | — |
Countries
Korea, Republic of
Contacts
Public ContactKangho Choi
Chonnam National University Hospital
Outcome results
None listed