NCT06920212进行中（未招募）不适用
Clinical Safety and Efficacy of FMT in the Treatment of Alzheimer's Disease
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy endpoints
研究概览
简要总结
To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months;
- •Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities;
- •MMSE scores ranging from 3 to 26;
- •MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.
排除标准
- •Patients were excluded if they had severe visual, hearing, or language impairments;
- •hepatic/renal dysfunction.
- •with conditions mimicking AD symptoms-such as normal pressure hydrocephalus, vascular dementia (VD or VaD);
- •Parkinson's disease dementia (PDD)-were also excluded;
- •patients who had participated in clinical drug trials within the past 30 days or consumed folate and vitamin B12 at doses exceeding twice the recommended intake were ineligible.
研究组 & 干预措施
FMT
Experimental
干预措施: FMT capsule (Procedure)
结局指标
主要结局
Efficacy endpoints
时间窗: 0, 1month, 2months, 3months, 6months
Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Changes in gut microbiota
时间窗: 0, 1month, 2months, 3month, 6months
Gut metagenomic sequencing was performed to conduct OTU (Operational Taxonomic Unit) clustering and taxonomic analysis, comparing alterations in patients' intestinal flora before and after FMT.
次要结局
未报告次要终点
研究者
Huanlong Qin
Dean of the hospital
Shanghai 10th People's Hospital
研究点 (1)
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