Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

Launched by CHINESE UNIVERSITY OF HONG KONG · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Synbiotic Formula (SCV09) study, is looking to see if a new combination of beneficial bacteria and nutrients can help improve behavior related to dementia in patients with Alzheimer's disease. Researchers believe that the health of our gut might play a role in brain health, and this study aims to explore that connection further. By testing this new formula in a small group of participants, the study hopes to gather important information that could lead to larger trials in the future.

To participate in this trial, individuals must be between 60 and 85 years old and have a diagnosis of Alzheimer's disease. They should also have a specific score on a cognitive test that indicates the level of dementia and have a caregiver to help them during the study. Participants will need to be stable on their current Alzheimer's medications and cannot have other serious health issues. This pilot study is not yet recruiting participants, but it represents an exciting step towards finding new ways to support people living with Alzheimer's.

Gender

ALL

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