Actively Recruiting
Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Led by Chinese University of Hong Kong · Updated on 2025-09-03
30
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 still largely unknown, successful therapies targeting the gut-brain axis may serve as indirect evidence of the possible linkage. This pilot, single-arm study aims to estimate the efficacy and assess the safety profile of the use of a new synbiotic formula (SCV09) in improving dementia-related behaviour in Alzheimer's disease patients, paving the way for a large-scale randomised controlled trial in the future.
CONDITIONS
Official Title
Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged between 60-85 with a clinical diagnosis of Alzheimer's disease
- Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score of �3C=20
- Neuropsychiatric Inventory-Questionnaire (NPI-12) score of �3E=10
- Stable medication history for Alzheimer's disease within the past 4 weeks
- Have a responsible caregiver able to assist with study product intake, stool sample collection, and clinical follow-up
- Able to provide informed consent
You will not qualify if you...
- Concomitant Parkinson's disease or other neurodegenerative conditions affecting daily activities
- History of stroke
- History of severe organ failure, including decompensated cirrhosis, or renal failure on dialysis
- HIV infection
- Confirmed active cancer
- Operations involving small or large intestines, or appendectomy, hysterectomy, cholecystectomy within last 6 months
- Use of antipsychotics, antidepressants or sedatives unless stable dose for last 3 months
- Inability to take oral fluids
- Use of antibiotics, probiotics or prebiotics in the last 2 weeks
- Intolerance to probiotics or lactose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Chinse University of Hong Kong
Shatin, Hong Kong
Actively Recruiting
Research Team
P
Professor Timothy Kwok
CONTACT
J
Joanna Cheng, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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