Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

University Hospital, Caen5 个研究点分布在 1 个国家目标入组 295 人开始时间: 2008年1月1日最近更新: 2013年3月6日

适应症

干预措施

试验速览

阶段: 不适用
发起方: University Hospital, Caen
入组人数: 295
试验地点: 5
主要终点: APOE genotype

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

to identify, compare and combine predictive markers of Alzheimer's disease
to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
to study the ability of different neuroimaging techniques to follow the evolution of this 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: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Education level > 7 years
•Native language: French
•Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
•Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
•Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
•Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
•MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
•Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).

排除标准

•The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
•A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
•A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
•A medication that may interfere with memory or metabolic measures
•A alcohol or drugs abuse
•claustrophobia, metallic object in the body
•A predominantly left-hand (score below 50% in Edinburgh Inventory).
•Protected adults, and persons not affiliated with a social security system will not participate in this study.
•The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)