Alzheimer Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSCV09
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Contacts
Primary ContactProfessor Timothy Kwok
Backup ContactJoanna Cheng, MSc
Outcome results
None listed