A Pilot, Single-arm Study on the Efficacy and Safety of the Use of a Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Neuropsychiatric Inventory-Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single arm intervention only
SV09
1 sachet daily for 6 months
干预措施: SCV09 (Dietary Supplement)
结局指标
主要结局
Neuropsychiatric Inventory-Questionnaire
时间窗: 6 months
Proportion of subjects who have no change or at least a 1 point decrease in Neuropsychiatric Inventory-Questionnaire (NPI-12) score
次要结局
- Activities of Daily Living(6 months)
- HK-MoCA(6 months)
- Gut microbiota composition and functions(6 months)
研究者
Timothy Kwok
Professor
Chinese University of Hong Kong