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.
• 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