SCV09 synbiotic for improving behavioral symptoms in Alzheimer's disease
A Pilot, Single-arm Study on the Efficacy and Safety of the Use of a Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
This pilot will try a synbiotic formula called SCV09 to see if it improves dementia-related behavior in people aged 60–85 with Alzheimer's disease who have a caregiver to assist with treatment and sample collection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06948929 on ClinicalTrials.gov |
What this trial studies
This is a pilot, single-arm study administering the synbiotic formula SCV09 to patients with Alzheimer's disease who meet preset cognitive and behavioral thresholds. Eligible participants aged 60–85 with HK-MoCA ≤20 and NPI-12 ≥10 and a stable Alzheimer's medication history will receive SCV09 while being monitored for safety and changes in behavior. Clinical visits and stool sample collection will be used to track behavioral outcomes and explore gut microbiota changes associated with treatment. Findings are intended to estimate efficacy and safety and to inform the design of a future larger randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are people aged 60–85 with a clinical diagnosis of Alzheimer's disease, HK-MoCA ≤20, NPI-12 ≥10, stable Alzheimer's medications, and a caregiver who can assist with treatment and stool sample collection.
Not a fit: Patients with concomitant Parkinson's disease or other neurodegenerative conditions affecting daily activities, a history of stroke, severe organ failure, active malignancy, recent major abdominal surgery, or on dialysis would be excluded and are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, SCV09 could reduce dementia-related behavioral symptoms and improve daily functioning and caregiver burden.
How similar studies have performed: Some small studies targeting the gut-brain axis have shown promising signals, but evidence remains limited and the approach is still experimental.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shatin
- The Chinse University of Hong Kong — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Professor Timothy Kwok — Chinese University of Hong Kong
- Study coordinator: Professor Timothy Kwok
- Email: tkwok@cuhk.edu.hk
- Phone: +852 35053145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.