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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm intervention only | Experimental | SV09 1 sachet daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric Inventory-Questionnaire | Proportion of subjects who have no change or at least a 1 point decrease in Neuropsychiatric Inventory-Questionnaire (NPI-12) score | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Activities of Daily Living | Changes in activities of daily living, assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | 6 months |
| HK-MoCA | Changes in Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Timothy Kwok | Contact | +852 35053145 | tkwok@cuhk.edu.hk | |
| Joanna Cheng, MSc | Contact | +852 35053990 | chengoiyue@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Professor Timothy Kwok | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinse University of Hong Kong | Recruiting | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 6 months |
| Gut microbiota composition and functions | Explore the gut microbiota composition and functions from stool sample | 6 months |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |