Status:
RECRUITING
Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-90 years
Phase:
NA
Brief Summary
In recent years, emerging studies have revealed the role of gut microbiota in human health and diseases, including AD and other neurodegenerative conditions5. Although the underlying mechanism is stil...
Eligibility Criteria
Inclusion
- Individuals aged between 60-85 with a clinical diagnosis of Alzheimer's disease
- Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score of ≤20
- Neuropsychiatric Inventory-Questionnaire (NPI-12) ≥10
- Stable medication history for Alzheimer's disease within the past 4 weeks
- Have been taken care by a responsible caregiver who could assist the patient in taking the study products, collecting stool samples and attending the clinical follow-up •-Able to provide informed consent
Exclusion
- Concomitant Parkinson's disease and other neurodegenerative conditions affecting activities of daily living
- History of stroke
- History of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection
- Confirmed active malignancy
- Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months
- Use of anti-psychotics, antidepressants or sedatives, unless on a stable dose in the last 3 months
- Inability to receive oral fluids
- Use of antibiotics, probiotics or prebiotics in the last 2 weeks
- Intolerance to probiotics or lactose
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06948929
Start Date
May 15 2025
End Date
December 15 2026
Last Update
September 3 2025
Active Locations (1)
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1
The Chinse University of Hong Kong
Shatin, Hong Kong