A Two-Part Cross-Sectional and Longitudinal Study to Assess Regional Cerebral Blood Flow by Dynamic Arterial Spin Labeling as an Alzheimer's Disease Biomarker as Compared to FDG-PET in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Regional cerebral blood flow, as measured by dASL.
研究概览
简要总结
The aim of the study is to determine if regional cerebral blood flow, measured by dynamic arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's disease, and participants with normal cognition. Various imaging studies will be done using magnetic resonance imaging (MRI) and positron emission tomography (PET) along with neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8 study visits. Repeat imaging studies may be required if the initial data are incomplete or un-interpretable. The maximum number of PET scans during the study will be limited to four.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.
- •The participant:
- •Has mild-to-moderate Alzheimer's Disease (AD), OR is considered cognitively normal;
- •Has been on stable doses of any regularly used medications for 4 weeks prior to study start;
- •Must have been on a stable dose for 12 weeks prior to study start, of any medications taken for AD.
排除标准
- •If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
- •The participant:
- •Is living in a nursing home or skilled nursing facility;
- •Has severe AD;
- •Cannot undergo MRI;
- •Cannot undergo PET scans;
- •Has a history of neurological or neurodegenerative disorders, other than AD within 2 years prior to study start;
- •Has taken Tacrine or anti-parkinsonian medications within 3 months of study start;
- •Has taken corticosteroids, blood thinners, narcotic analgesics, benzodiazepines, or certain antihistamines within 1 month of study start;
- •Initiates, discontinues, or changes the dose of any AD treatment during the study.
结局指标
主要结局
Regional cerebral blood flow, as measured by dASL.
时间窗: 1 week, 6 and 12 months
Part I: regional cerebral blood flow, measured by dASL at Baseline and 1 week in AD participants and cognitively normal controls. Part II: regional cerebral blood flow, measured at 6 months and 12 months in AD participants and normal control participants.
次要结局
- Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET)(12 months)
- Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response(1 week, 6 and 12 months)