Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Dietary supplement: SCV09

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Professor Timothy Kwok; Phone Number: +852 35053145; Email: tkwok@cuhk.edu.hk
• Study Contact Backup: Name: Joanna Cheng, MSc; Phone Number: +852 35053990; Email: chengoiyue@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • The Chinse University of Hong Kong
    • Contact: Professor Timothy Kwok; Phone Number: +852 35053145; Email: tkwok@cuhk.edu.hk
    • Contact: Joanna Cheng, MSc; Phone Number: +852 35053990; Email: chengoiyue@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm intervention only; SV09 1 sachet daily for 6 months	Dietary supplement: SCV09; SCV09 consists of a blend of four probiotic species from the Bifidobacterium and Lactobacillus genera (20 billion CFU in 1 sachet per day), prebiotic compounds including galacto-oligosaccharides, xylo-oligosaccharides and inulin, vitamin B6, B9, B12 and vitamin D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychiatric Inventory-Questionnaire	Proportion of subjects who have no change or at least a 1 point decrease in Neuropsychiatric Inventory-Questionnaire (NPI-12) score	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of Daily Living	Changes in activities of daily living, assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)	6 months
HK-MoCA	Changes in Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score	6 months
Gut microbiota composition and functions	Explore the gut microbiota composition and functions from stool sample	6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Professor Timothy Kwok, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 2024.530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No