Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Level of inflammatory markers
研究概览
简要总结
The main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).
详细描述
We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥65 years, able to give consent
- •Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
- •approximately equal male:female ratio
排除标准
- •Inability to give consent
- •other neurological disease
- •relevant psychiatric disorders (e.g. major depression)
- •gastrointestinal/metabolic conditions
- •history of alcohol/substance dependence
- •use of systemic antibiotics in the previous 6 months
- •corticosteroid use
- •immune stimulating medications
- •immunosuppressive agents
- •probiotics consumption in the previous 6 months.
- •immunosuppression
- •structural heart disease
- •neutropenia
- •radiation
- •active intestinal disease
研究组 & 干预措施
Probiotics
Participants received 1 capsule daily of probiotics, administered orally for 16 weeks.
干预措施: Probiotic Blend Capsule (Drug)
Placebo
Participants received 1 capsule daily of placebo, administered orally for 16 weeks.
干预措施: Probiotic Blend Capsule (Drug)
结局指标
主要结局
Level of inflammatory markers
时间窗: Baseline (week 0), end of study (week 16)
Peripheral inflammation markers implicated in the pathogenesis of mild-AD (pro-inflammatory cytokines: IL-6, IL-1β, CXCL2, NLRP3; anti-inflammatory cytokines: IL-10. Isolated from blood plasma.
次要结局
- Cognitive function and neuropsychological scores(Baseline (week 0), end of study (week 16))
- Neurophysiological activity changes(Baseline (week 0), end of study (week 16))
- Microbiome profile(Baseline (week 0))
研究者
Nicoletta Nicolaou
Associate Professor
University of Nicosia