Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Diet Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Brain biodistribution of [11C]AcAc
研究概览
简要总结
This is a single center imaging study that will recruit 60 participants who are enrolled in the Effect of a Ketogenic Diet on Alzheimer's Disease Biomarkers and Symptoms: Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study protocol. This cohort of patients will receive a maximum of 3 [11C]Acetoacetate (AcAc)/[18F]Fluorodeoxyglucose (FDG) PET scans over 18 weeks as part of this supplemental trial.
详细描述
The main objective of this study is to examine the brain biodistribution of [11C]AcAc/[18F]FDG, a proxy for acetoacetate (ketone body)/glucose metabolism in 3 study groups; 1) those without identifiable risk of Alzheimer's disease, 2) asymptomatic individuals with increased risk of Alzheimer's disease (such as pre diabetes),and 3) those with early Alzheimer's disease or MCI. Secondary objectives include determining the association between adipose tissue distribution/function and biomarkers of AD pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
No masking is used
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild cognitive impairment or subjective memory complaints
- •Stable medical condition and medications
- •Ability to complete baseline assessments
排除标准
- •History of a clinically significant stroke
- •Sensory impairment (visual, auditory)
- •Diabetes requiring medication
- •Current use of cholesterol/lipid lowering medications, anticonvulsants, drugs with potential interfering CNS effects (other than cholinesterase inhibitors or memantine), medications with significant anticholinergic activity, anti-parkinsonian medications or regular use of narcotic analgesics
- •Untreated hypothyroidism or B12 deficiency
结局指标
主要结局
Brain biodistribution of [11C]AcAc
时间窗: Change between baseline and four months
To assess change in brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Brain biodistribution of [18F]FDG -
时间窗: Change between baseline and 4 months
To assess change in brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)
次要结局
未报告次要终点