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临床试验/NCT02501876
NCT02501876已完成不适用

Type 2 Diabetes Mellitus as Accelerator for the Progression to Alzheimer's Disease in Patients With Mild Cognitive Impairment

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
1
主要终点
The rate of conversion to Alzheimer's disease (AD)

研究概览

简要总结

In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes and or the presence of its related genes favors the conversion of MCI to AD.

详细描述

In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, ie regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes favors the conversion of MCI to AD. We propose a case-control study comparing a group of 110 diabetic patients and a group of 110 non-diabetic patients with MCI matched by age, sex and cardiovascular risk factors. The main objective is the conversion to AD between the groups and if DM-2 is an independent risk factor. The secondary objective is to investigate whether genetic mechanisms related both to AD and DM-2 are associated with the increased risk of AD in diabetic patients. We will analyze 10 genes simultaneously associated with an increased risk of diabetes and / or its complications and AD.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of MCI using the NBACE neuropsychological tests battery.
  • Age >65 years.
  • At least two years follow-up.
  • 110 subjects with type 2 diabetes
  • 110 subjects without diabetes
  • written informed consent.

排除标准

  • patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale Fazekas (escor˃2)

结局指标

主要结局

The rate of conversion to Alzheimer's disease (AD)

时间窗: 6 months

次要结局

  • The presence of common alleles for Alzheimer's disease (AD) and Diabetes mellitus type 2(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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