Actively Recruiting

Phase Not Applicable
Age: 60Years - 90Years
All Genders
NCT06948929

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

Age: 60Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

The Chinse University of Hong Kong

Shatin, Hong Kong

Actively Recruiting

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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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