Mild Cognitive Impairment
Conditions
Interventions
MCI group:SCV09
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Chinese individuals aged between 60-85; 2.Mild cognitive impairment as determined by a Clinical Dementia Rating (CDR) = 0.5; 3.Hamilton Depression Rating Scale (HAM-D) >= 8, and that the mood symptoms occurred after MCI onset; 4.Having a family member or caregiver who could supervise the subject in taking the study products, collecting stool samples and attending the follow-up; 5.Able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with dementia, or already receiving drugs for dementia, such as cholinesterase inhibitors, memantine, and amyloid-targeting monoclonal antibodies; 2. Concomitant Parkinson’s disease and other neurodegenerative conditions affecting activities of daily living 3. Psychotic, suicidal, or treatment-resistant; 4. History of stroke; 5. History of severe organ failure (including decompensated cirrhosis), renal failure on ; dialysis, suffering from human immunodeficiency virus infection; 6. Pre-existing gastrointestinal diseases that significantly confound gut microbiota (eg, inflammatory bowel disease) 7. Confirmed active malignancy; 8. Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in the last 6 months; 9. Use of antipsychotics, antidepressants or sedatives, unless on a stable dose in the last 3 months; 10. Inability to receive oral fluids; 11. Use of antibiotics, probiotics or prebiotics in the last 2 weeks; 12. Intolerance to probiotics or lactose leading to a severe allergic reaction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with improvement in condition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-report improvement in condition;Changes in the Clinical Dementia Rating;Changes in Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score;Changes in the Chinese version of the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) score;Changes in Hamilton Depression Rating Scale (HAM-D);Changes in Hamilton Anxiety Rating Scale (HAM-A);Changes in the Neuropsychiatric Inventory (NPI) score;Changes in the gut microbiota composition and functions;Adverse event rates; | — |
Countries
China
Contacts
Public ContactAllen Ting Chun LEE
The Chinese University of Hong Kong
Outcome results
None listed