A Multicenter Study to Assess Differences Between Circulating Levels of IGF-I and IGFBP-3 in Patients With Sporadic Late-onset Alzheimer's Disease and Control Elderly Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 693
- 试验地点
- 2
- 主要终点
- Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0).
研究概览
简要总结
The aim is to assess the relationship between levels of IGF-I system components and cognitive status in patients with Alzheimer's disease (AD), in elderly subjects with normal cognitive function, and in patients with mild cognitive impairment (MCI).
详细描述
AD is the most common cause of dementia. During aging, decline of biological brain functions due to a number of genetic and environmental factors facilitates the onset of AD. MCI includes prodromal AD.
The identification of the risk factors for AD must be a priority in order to define the best therapeutic approach.
Recent data support the notion that IGF-I pathway accounts for neuronal protection, with a dual effect, on both brain Aβ peptide and tau protein.
This large, multicenter, prospective, observational, cross-sectional population-based study in 3 parallel groups (200 participants per group) is aimed to assess differences between IGF-I and IGFBP3 circulating levels and polymorphisms in AD patients and control elderly subjects, and in MCI patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian patients after a comprehensive geriatric assessment and giving informed written consent.
- •- In each arm :
- •elderly subjects with normal cognitive function,
- •patients with dementia of AD type (DSM-IV and NINCDS-ADRDA criteria),
- •patients with MCI (European Consortium on Alzheimer's Disease, EADC).
排除标准
- •Non AD dementia Major depression Use of anticholinesterase agent All diseases or major sensory deficits or any condition that might interfere with cognitive assessment and study objectives
研究组 & 干预措施
1
AD
2
Control elderly subjects with normal cognitive function
3
MCI
结局指标
主要结局
Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0).
时间窗: 24 hours
次要结局
- Circulating IGF-I and IGFBP-3 levels(24 hours)
- Genetic polymorphisms in IGF-I / IGFBP-3(24 hours)
- Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function.(24 hours)