Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Dietary Supplement: SCV09

Study type: Interventional

Funder types: Other

Identifiers

NCT06948929

2024.530

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single arm intervention only

Experimental group

Description:

SV09 1 sachet daily for 6 months

Treatment:

Dietary Supplement: SCV09