A Composite MR Neuroimaging Marker for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine the sensitivity and specificity of the MRN Index as an AD biomarker.
研究概览
简要总结
The purpose of this study is to use a functional MRI (fMRI) index to compare the brain activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's disease.
The study hypotheses are:
- The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia, and healthy volunteers;
- The fMRI index will distinguish participants with MCI who convert to Alzheimer's disease from those who convert to a non-Alzheimer's dementia and those who remain stable;
- MCI participants with a lower fMRI index at baseline who convert will progress to Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's disease.
详细描述
The onset of Alzheimer's disease is insidious and the boundary between normal aging and Alzheimer's disease is blurred. In order to prevent and treat Alzheimer's disease, the investigators must be able to mark its preclinical stage, before brain damage becomes irreversible. There is a substantial body of research dealing with predictive markers of Alzheimer's disease in individuals with mild cognitive impairment (MCI). Despite these advances, however, researchers have not had enough evidence to recommend specific techniques that mark preclinical Alzheimer's disease. This new functional MRI (fMRI) index may fill this gap.
Participants will have two visits, one for memory testing and neurological examination, and one for an MRI scan. Each visit will take approximately 1½ hours. For volunteers who wish to do so, all study procedures may be completed in a single visit. Participants with MCI will be followed annually.
The investigators are currently enrolling healthy volunteers, as well as individuals with MCI (memory loss that does not significantly affect normal daily activities), Alzheimer's disease, and frontotemporal dementia (includes primary progressive aphasia).
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years of age or older (50 years of age or older for frontotemporal dementia patients)
- •Normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of Alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia)
- •Right-handed
- •General good physical health
排除标准
- •History of stroke or neurological disease (other than Alzheimer's disease or frontotemporal dementia)
- •Seizures or head injury with loss of consciousness within the last five years
- •Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner)
- •Claustrophobia
结局指标
主要结局
To determine the sensitivity and specificity of the MRN Index as an AD biomarker.
时间窗: 5 years
次要结局
未报告次要终点