Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

Early Phase 1

Not yet recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT06948929
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Study Start: 2025-05-15
• Primary Completion: 2026-05-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Chinse University of Hong Kong; 🇭🇰 Shatin, Hong Kong