NCT06948929

Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

Recruiting · Not Applicable · Chinese University of Hong Kong · registry updated 2025-09-03

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

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.

Inclusion

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

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

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