Examining Neuroinflammation in AlzHeimer's Disease Via TrAnscriptomic ProfiliNg and MiCroglia ModEling Using Human Peripheral Blood Mononuclear Cells (ENHANCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 14
- 主要终点
- Adiponectin
研究概览
简要总结
Alzheimer disease (AD) is a neurodegenerative disorder with a poorly understood pathology. It is an irreversible progressive brain disease that slowly deteriorates memory, thinking and behavior. It affects the elderly population and is also hereditary. The incidence doubles with every decade after sixty with no signs of leveling off. More than 35 million people Worldwide, including 5.5 million living in the United States, suffer from AD. As the United States population ages, it is expected that the number of people with AD will increase, reaching 13.2 to 16.0 million by the year 2050. The cost of care for patients with AD in the United States is expected to rise as well, from $172 billion a year in 2010 to a trillion dollars a year by 2050.
Although the exact etiopathology is not known there are several lines of evidence that suggest that metabolic and inflammatory features are important. It also has been known for many years that the Blood Brain Barrier (BBB) of Alzheimer's patients allow more harmful particles to cross into the brain than the BBBs of those without the disease do. It's known that this barrier, which is regulating transfer of molecules between the brain and blood, and vice versa blood and brain, can become leaky and dysfunctional (in particular capillaries dysfunction) and lead to subsequent problems likely contributing to onset and progression of dementia. This protocol will explore several of the most promising putative factors that cause AD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adiponectin
时间窗: Two years
Measured of adiponectin level in the blood
Height
时间窗: Two years
Measured in meters
Lipid profile
时间窗: Two years
Measured of the HDL, LDL and VLDL content in the blood (measured in mg/dL)
Compare the Blood Brain Barrier leaking between AD, T2D and healthy control subjects.
时间窗: Two years
A MRI of the brain with contrast will be used to assess the permeability of the Blood Brain Barrier.
Age
时间窗: Two years
Measured in years
BMI
时间窗: Two years
will be determined by dividing weight by height (square)
Gender
时间窗: Two years
(Male or Female)
Body composition
时间窗: Two years
Measured by Dexascan
Weight
时间窗: Two years
Measured in kilograms
Race
时间窗: Two years
White/Black or African American/Asian/Other/Unknown or not reported
Insulin
时间窗: Two years
Measured of insulin level in the blood
Cognitive data
时间窗: Two years
Evaluated by the Geriatric Depression Scale (GDS)
Free Fatty Acid
时间窗: Two years
Measured of free fatty acid level in the blood
Transcriptomic profiles of the cells isolated from the blood
时间窗: Two years
after isolation of the peripheral blood mononuclear cell (PBMC) from the blood, measure of gene expression by RT-qPCR (real time quantitative polymerase chain reaction)
Activity monitoring - lying down time
时间窗: Two years
measured by wearing an arm band - measured in minutes
Proteomic of the cells isolated from the blood
时间窗: Two years
after isolation of the PBMC from the blood, measure of proteins by western blot
Activity monitoring - energy cost of free-living activity
时间窗: Two years
measured by wearing an arm band - measured in minutes
Epigenetic
时间窗: Two years
after isolation of the PBMC from the blood measure of DNA methylation
Metabolic of the cells isolated from the blood
时间窗: Two years
after isolation of the PBMC from the blood measure of metabolites by MS
Activity monitoring - sleeping time
时间窗: Two years
measured by wearing an arm band - measured in minutes
次要结局
未报告次要终点