Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence
研究概览
简要总结
Aging is the primary risk factor in aging-related dementia. An important initiating factor for the development and progression of cognitive impairment is disruption of the blood-brain barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and protecting neural tissues from toxins. It is hypothesized that such changes known to be common in aging and can be an early process that precedes Alzheimer's Disease (AD). The microvascular changes related to subtle BBB disruption can be measured with permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and the patterns of increased PS in normal and abnormal aging are different.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects that have been diagnosed with aMCI ages 65-85
排除标准
- •Pregnant, planning to get pregnant, or nursing.
- •Claustrophobia
- •Cardiac pacemaker
- •Intracranial clips, metal implants, unremovable jewelries, metal in eyes.
- •History or presence of any other major medical, neurologic or psychiatric conditions, such as Alzheimer's diseases, Parkinson's diseases, and stroke.
- •Renal or liver disease as this may cause concerns related to Gad-based contrast agent
- •Allergy to the contrast agent Gadolinium
研究组 & 干预措施
Cohort A
Cognitively normal control participants aged 20 - 40 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.
干预措施: GRASP Dynamic Contrast-Enhanced (DCE) MRI (Device)
Cohort A
Cognitively normal control participants aged 20 - 40 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.
干预措施: 3T Brain Scan (Device)
Cohort A
Cognitively normal control participants aged 20 - 40 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.
干预措施: Gadolinium-based Contrast Agent (GBCA) for MRI (Drug)
Cohort B
Cognitively normal control participants aged 65 - 85 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.
干预措施: GRASP Dynamic Contrast-Enhanced (DCE) MRI (Device)
Cohort B
Cognitively normal control participants aged 65 - 85 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.
干预措施: 3T Brain Scan (Device)
Cohort B
Cognitively normal control participants aged 65 - 85 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.
干预措施: Gadolinium-based Contrast Agent (GBCA) for MRI (Drug)
Cohort C
Amnestic mild cognitive impairment (aMCI) patients aged 65 and older. Participants in Cohort C will be matched by age and gender to participants in Cohort B. Participants in Cohort C will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 9 minutes of scan time.
干预措施: GRASP Dynamic Contrast-Enhanced (DCE) MRI (Device)
Cohort C
Amnestic mild cognitive impairment (aMCI) patients aged 65 and older. Participants in Cohort C will be matched by age and gender to participants in Cohort B. Participants in Cohort C will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 9 minutes of scan time.
干预措施: 3T Brain Scan (Device)
Cohort C
Amnestic mild cognitive impairment (aMCI) patients aged 65 and older. Participants in Cohort C will be matched by age and gender to participants in Cohort B. Participants in Cohort C will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 9 minutes of scan time.
干预措施: Gadolinium-based Contrast Agent (GBCA) for MRI (Drug)
结局指标
主要结局
Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence
时间窗: Up to 21 Minutes
Golden-angle Radial Sparse Parallel (GRASP) dynamic contrast-enhanced (DCE) MRI sequence will be collected for the quantification of subtle BBB leakage throughout the brain.
Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence
时间窗: Up to 21 Minutes
PS is measured by quantifying the contrast agent flow through blood vessel walls per unit volume of brain while accounting for the blood flow rate in the vessel.
次要结局
未报告次要终点