NCT06948929 Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
| NCT ID | NCT06948929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-05-15 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Professor Timothy Kwok
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06948929 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 90 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06948929 currently recruiting?
Yes, NCT06948929 is actively recruiting participants. Contact the research team at tkwok@cuhk.edu.hk for enrollment information.
Where is the NCT06948929 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06948929 clinical trial?
NCT06948929 is sponsored by Chinese University of Hong Kong. The principal investigator is Professor Timothy Kwok at Chinese University of Hong Kong. The trial plans to enroll 30 participants.
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