Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Mitochondrial oxygen consumption of peripheral blood cells
研究概览
简要总结
This project aims to study on one hand the early mitochondrial alterations, common or specific, occurring in peripheral cells of patients with Alzheimer's disease or related dementia and, on the other hand, identify the metabolomic biomarkers that may be at the origin of mitochondrial disturbances associated with the disease. This will be the first study combining functional analyses of mitochondria and exploratory metabolomic assessments in the same cohort at early stages of the disease.
详细描述
Study will be proposed to the patient of the Nice Memory center who had a lumbar puncture and who agreed on the storage of a sample of their cerebrospinal fluid.
Two groups of patients will be compared: the Alzheimer"s disease patient with positive amyloid on the cerebrospinal fluid and the non Alzheimer patient with negative amyloid on the cerebrospinal fluid.
there will also be a group of healthy volonteer with one blood sample
Blood samples will be collected at inclusion and one year to obtain the mitochondrial metabolomic signature
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurocognitive disorder with spontaneous complaint or reported for at least 6 months
- •Diagnostic process according to current Haute Autorité de Santé (HAS) recommendations.
- •cerebrospinal fluid biomarker dosage done within the study center and agreement to bio-collection of residual cerebrospinal fluid
- •Patient having agreed to sign the informed consent
- •Patient affiliated or beneficiary of a social security scheme
- •For alzheimer group : diagnosis of Alzheimer's disease according to NIA-AA 2024 criteria (presence of a pathogenic amyloid process in the cerebrospinal fluid)
- •For non alzheimer group : diagnosis of mild or major neurocognitive disorder according to Manuel diagnostique et statistique des troubles mentaux edition 5 (DSM-V) criteria, not linked to Alzheimer's disease (absence of pathogenic amyloid process in the cerebrospinal fluid)
- •For healthy volonteers:
- •Adult patients
- •No history of neurological or psychiatric disorders
- •No complaints of memory problems or cognitive impairment
- •Mini-Mental State Examination (MMSE) score ≥ 27/30
- •Clinical Dementia Rating - Sum of Boxes (CDR-SOB) equal to 0
- •Patient affiliated with or covered by a social security scheme
排除标准
- •- Vulnerable people
研究组 & 干预措施
ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS
Recruitment of 75 patients with amyloid positive marker on cerebrospinal fluid and 75 patients with amyloid negative marker on cerebrospinal fluid and 75 healthy volonteers
干预措施: MMSE and blood draw (Other)
结局指标
主要结局
Mitochondrial oxygen consumption of peripheral blood cells
时间窗: At 1 year
Comparison of the rate of mitochondrial oxygen consumption of peripheral blood cells between alzheimer (amyloid positive) and non-Alzheimer participant (amyloid negative) in pmol/min/cell mesured by Extracellular Flux Analyzer
Mitochondrial oxygen consumption of peripheral blood cells
时间窗: At Baseline
Comparison of the rate of mitochondrial oxygen consumption of peripheral blood cells between alzheimer (amyloid positive) and non-Alzheimer participant (amyloid negative) in pmol/min/cell mesured by Extracellular Flux Analyzer
次要结局
- Mini Mental State Examination Scores for Cognitive Impairment(At Baseline and at one year)
- Mitochondrial metabolomic signature(At Baseline and at one year)