NCT03487380终止不适用
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- analysis of the taxonomic and functional composition of the microbiome
研究概览
简要总结
The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Alzheimer groups without DCR and Alzheimer with DCR:
- •patients between 70 and 90 years old
- •with mild to moderate Alzheimer's disease (MMSE> 15/30),
- •followed in the CMRR of the University Hospital of Nantes or Angers
- •having given their informed consent
- •For the control group (non-Alzheimer's)
- •more patients between 70 and 90 years
- •consultant for a subjective memory complaint isolated at the CMRR of Nantes or Angers University Hospital,
- •having given their informed consent
排除标准
- •Major patients under tutorship, curatorship or safeguard of justice
- •Cognitive disorders possibly related to a metabolic or psychiatric cause
- •History of prescription of antibiotic treatment in the last month
- •History of acute gastrointestinal illness in the last month
- •History of hospitalization for an acute medical pathology or for a surgical procedure in the last month
研究组 & 干预措施
Control
Sham Comparator
干预措施: Fecal sample collection (Procedure)
Alzheimer with rapid DCR
Experimental
干预措施: Fecal sample collection (Procedure)
Alzheimer without rapid DCR
Experimental
干预措施: Fecal sample collection (Procedure)
结局指标
主要结局
analysis of the taxonomic and functional composition of the microbiome
时间窗: 1 year
("shotgun sequencing"), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.
次要结局
- to determine if there is a specific modification of the composition of the intestinal microbiota of patients with Alzheimer's disease, compared to control group.(Day 0)
- create a prognostic score of DCR based on clinical data, including the responses to the MMSE, BREF and MNA questionnaires, and taking into account the microbiota analysis(1 year)
研究者
研究点 (2)
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