Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCV09.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: 60 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot, Single-arm Study on the Efficacy and Safety of the Use of a Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Neuropsychiatric Inventory-Questionnaire [Time frame: 6 months]
Secondary outcome measures (3)
- Activities of Daily Living [Time frame: 6 months]
- HK-MoCA [Time frame: 6 months]
- Gut microbiota composition and functions [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Hong Kong · 1 center
- The Chinse University of Hong Kong — Shatin
Identifiers
NCT: NCT06948929 · 2024.530