Cerebrospinal Fluid Markers of Synaptic Injury and Functional Connectivity in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Correlations between CSF biomarker measurements and fMRI measures of functional connectivity at baseline
研究概览
简要总结
The purpose of this study is to examine cross-sectional associations between CSF markers of synaptic injury (Ng and SNAP-25) and functional connectivity in default and semantic memory networks using 3T- fMRI in individuals with MCI (i.e. the earliest clinically detectable stage of cognitive impairment) due to AD or mild AD dementia (CDR 0.5-1; n=20) and cognitively normal controls (CDR 0; n=20).
详细描述
SPECIFIC AIMS:
Aim 1: Investigate correlations between CSF biomarkers of synaptic injury (Ng and SNAP-25) and functional connectivity (FC) within the default mode network (DMN) using resting-state fMRI (adjusting for age, gender, apolipoprotein-E4 [APOE4] genotype, task performance, and regional brain atrophy) in MCI/AD and controls.
Aim 2: Examine correlations between CSF biomarkers of synaptic injury and functional connectivity (FC) within the semantic memory network on task-activated fMRI using the Famous Name Discrimination Task (FNDT) (adjusting for age, gender, APOE4 genotype, task performance, and regional brain atrophy) in MCI/AD and controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants included in the study should meet all 4 inclusion criteria:
- •60 years of age or older
- •A clinical diagnosis of MCI, mild AD dementia, or normal cognition
- •No significant medical or surgical co-morbidities
- •No contraindications to LP or MRI.
- •Exclusion criteria: Participants with any of the following criteria will be excluded from the study:
- •Participants with MCI due to AD or mild AD dementia who have been treated with cholinesterase inhibitors or glutamate antagonists in the 3 months prior to study enrollment
- •Individuals with any past history of ischemic or traumatic brain injury
- •Individuals with imaging evidence of significant cerebrovascular disease or structural brain lesions (e.g. tumor, demyelinating disorders, infection, or congenital anomalies)
- •Active mood disorder
- •Active alcohol use
- •Active use of benzodiazepines, barbiturates, anticholinergic, or anti-epileptic medications
排除标准
- 未提供
结局指标
主要结局
Correlations between CSF biomarker measurements and fMRI measures of functional connectivity at baseline
时间窗: Study duration is 3 years (36 months) for each participant, including 3 visits: one for cognitive evaluations, one for fMRI, and one for CSF collection.
Cross-sectional associations between CSF biomarker measurements and fMRI measures at baseline
次要结局
- Functional Connectivity measures on functional MRI (r)(fMRI will be performed for each participant once during the study (within 3 years of study enrollment).)
- CSF levels of tau, p-tau181, Abeta42, Ng, and SNAP-25 (pg/ml)(CSF collection will be performed for each participant once during the study (within 3 years of study enrollment).)
研究者
Rawan Tarawneh
Assistant Professor of Neurology
Ohio State University