Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Recruiting · NCT06948929 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- The Chinse University of Hong Kong - Shatin, Hong Kong