A Pilot, Single-arm Study on the Efficacy and Safety of the Use of a Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
The Chinse University of Hong Kong
RECRUITING
Shatin
Contact Information
Primary
Professor Timothy Kwok
tkwok@cuhk.edu.hk
+852 35053145
Backup
Joanna Cheng, MSc
chengoiyue@cuhk.edu.hk
+852 35053990
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 30
Treatments
Experimental: Single arm intervention only
SV09~1 sachet daily for 6 months
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov