NCT04841135招募中不适用
Analysis of the Blood Signature of the Microbiota as a Diagnostic Marker of Alzheimer's Disease in the Early Stages of the Process: Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Concentration of bacterial 16S rDNA in stools
研究概览
简要总结
This study aims to validate a difference in blood microbial signature between Alzheimer's patients and control subjects in order to propose potential innovative strategies
详细描述
This is a pilot study only carried out in Montpellier, aimed at comparing AD patients with control subjects, including men / women aged between 50 and 85 years. The diagnosis of AD patients is based on international criteria. Metagenomics and proteomics will be used to determine the composition of the microbiota in whole blood and stools, but also the metabolomic profile in plasma, stool and the urines.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General criteria for AD and control groups:
- •Male and/or female;
- •Age between 50-85 years;
- •Having given their free, informed, written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
- •Patient benefiting from a social security scheme
- •Diagnosis of Alzheimer's disease according to the international ATN criteria of Albert et al, (1) who had a diagnostic lumbar puncture and CSF biomarker assay and brain imaging with analysis of hippocampal atrophy; topographic and pathophysiological markers must be positive to confirm the etiopathogenic diagnosis;
- •Mild to moderate stage with MMSE score between 10 and 26 ;
- •Symptomatic treatments specific to Alzheimer's disease (acetylcholinesterase inhibitors and memantine) and psychotropic treatments (anxiolytics, antidepressants, neuroleptics) are authorized but must be at fixed doses for more than 3 months ;
- •Control group:
- •Patients seen in memory consultation for concern of having AD but for whom the workup is normal. These patients will have had a diagnostic lumbar puncture during the same memory consultation.
- •Neurotypical group criteria:
- •Male and/or female ;
- •Age between 18-35 years or between 50-85 years;
- •Having given their free, informed, written and signed consent by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
- •Patients without cognitive complaints seen in memory consultation but for whom the assessment is normal or young subjects recruited by advertisement. These participants will have an ex-post determination of plasma Aß and tau biomarkers.
- •Exclusion criteria:
- •General criteria for AD and control groups:
- •Absence of a family caregiver to complete the neuropsychological scales and questionnaires ;
- •Patient living in a medical institution;
- •Illiteracy or inability to complete the psycho-behavioral tests;
- •Major physical or neurosensory problems likely to interfere with the tests;
- •Contra-indication or refusal to perform the biological tests;
- •Refusal to carry out neuropsychological tests.
- •Refusal of stool collection
- •Digestive neoplasia in progress or < 5 years old
- •Digestive surgery with intestinal resection ;
- •Presence of inflammatory bowel disease or other familial gastrointestinal pathology ;
- •Chronic use of laxatives;
- •Antibiotics taken within one month prior to inclusion;
- •Short-term life-threatening conditions (active cancer, unstable heart failure, severe liver, kidney and respiratory failure);
- •Chronic psychosis or psychotic episodes;
- •Alcohol or drug addiction;
- •Epilepsy and other non-degenerative diseases of the central nervous system
- •Vitamin B12 deficiency and unsupplemented folic acid ;
- •Untreated hypothyroidism;
- •Patient deprived of liberty, by judicial or administrative decision;
- •Major protected by law;
- •Patient in a period of relative exclusion from another protocol;
- •Refusal to participate in the protocol.
- •Insufficient clinical and paraclinical information for the diagnosis of AD;
- •Genetic form of AD (known genetic mutation);
- •Control and neurotypical groups: No specific non-inclusion criteria
排除标准
- 未提供
结局指标
主要结局
Concentration of bacterial 16S rDNA in stools
时间窗: 22 months
Concentration of bacterial 16S rDNA in stools
次要结局
- Concentration of bacterial 16s DNA in blood(22 months)
- Multiomics microbiota signature in AD(22 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of DementiaDementiaAlzheimer's DiseaseNCT00880347Exonhit550
Unknown
不适用
Gut Microbiota and Alzheimer's DiseasesAlzheimer DiseaseNCT03827733Shanghai 10th People's Hospital200
已完成
不适用
Novel Diagnostic and Disease Stage Biomarkers in ADAlzheimer DiseaseMild Cognitive ImpairmentNeuro-Degenerative DiseasesDementia With Lewy BodiesHealthy ControlsVascular DementiaNCT05175664Danish Dementia Research Centre350
Unknown
3 期
A Pilot Study of Inflammatory Markers in Alzheimer's DiseaseAlzheimer's DiseaseNCT00715858McMaster University21
已完成
不适用
Biomarker Study for Alzheimer's DiseaseAlzheimer's DiseaseNCT02472899Beersheva Mental Health Center115