NCT06948929Recruiting
Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
A Pilot, Single-arm Study on the Efficacy and Safety of the Use of a Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 28 Apr 2025
- Start date
- 15 May 2025
- Primary completion date
- 15 May 2026
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Alzheimer disease
- NCT number
- NCT06948929
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 May 2025 to the primary completion date, 15 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant Parkinson's disease and other neurodegenerative conditions affecting activities of daily living
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 60 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinse University of Hong Kong Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.