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NCT Number: NCT06948929

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinse University of Hong Kong

Shatin, Hong Kong

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Neuropsychiatric Inventory-Questionnaire

    Time frame: 6 months

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

Secondary outcomes

  1. Activities of Daily Living

    Time frame: 6 months

    Changes in activities of daily living, assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

  2. HK-MoCA

    Time frame: 6 months

    Changes in Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score

  3. Gut microbiota composition and functions

    Time frame: 6 months

    Explore the gut microbiota composition and functions from stool sample

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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