Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

NCT06948929 | Recruiting

• 1 other identifier: 2024.530
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Activities of Daily Living

  6 months

• HK-MoCA

  6 months

• Gut microbiota composition and functions

  6 months

Study Arms (1)

Single arm intervention only

EXPERIMENTAL

SV09 1 sachet daily for 6 months

Dietary Supplement: SCV09

Interventions

SCV09 DIETARY_SUPPLEMENT

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.

Single arm intervention only

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinse University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Professor Timothy Kwok

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Timothy Kwok

CONTACT

+852 35053145; tkwok@cuhk.edu.hk

Joanna Cheng, MSc

CONTACT

+852 35053990; chengoiyue@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: April 29, 2025
• Study Start: May 15, 2025
• Primary Completion: May 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)