Cerebral Substrates of Prospective Memory in Healthy Young Adults and Disruptions in Normal Aging and Alzheimer Disease: a Study in Anatomical, Functional and Diffusion Tensor MRI.
试验速览
- 阶段
- 不适用
- 入组人数
- 118
- 试验地点
- 3
- 主要终点
- Rate of volume change of whole brain and other structural MRI measures
研究概览
简要总结
The purpose of this study is to investigate prospective merory (memory of intentions) in healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Beck < 7
- •Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:
- •Young Healthy Subjects: between 18 and 44 years old;
- •Middle age Healthy Subjects: between 45 and 69 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
- •Elderly Healthy Subjects: over 70 years old, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
- •MCI patients: over 50 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 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: over 50 years old, 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 ≥ 18).
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 (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.
- •Pregnant or suckling women
- •The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)
研究组 & 干预措施
Mild Cognitive Impairment patients
干预措施: Functional MRI (Other)
Mild Cognitive Impairment patients
干预措施: Virtual reality / Memory assessment (Other)
Alzheimer Disease patients
干预措施: Memory assessment (Behavioral)
Alzheimer Disease patients
干预措施: Structural MRI (Other)
Alzheimer Disease patients
干预措施: Functional MRI (Other)
Alzheimer Disease patients
干预措施: Virtual reality / Memory assessment (Other)
Young Healthy Subjects
干预措施: Memory assessment (Behavioral)
Young Healthy Subjects
干预措施: Structural MRI (Other)
Young Healthy Subjects
干预措施: Functional MRI (Other)
Young Healthy Subjects
干预措施: Virtual reality / Memory assessment (Other)
Middle age Healthy Subjects
干预措施: Memory assessment (Behavioral)
Middle age Healthy Subjects
干预措施: Structural MRI (Other)
Middle age Healthy Subjects
干预措施: Functional MRI (Other)
Middle age Healthy Subjects
干预措施: Virtual reality / Memory assessment (Other)
Elderly Healthy Subjects
干预措施: Memory assessment (Behavioral)
Elderly Healthy Subjects
干预措施: Structural MRI (Other)
Elderly Healthy Subjects
干预措施: Functional MRI (Other)
Elderly Healthy Subjects
干预措施: Virtual reality / Memory assessment (Other)
Mild Cognitive Impairment patients
干预措施: Memory assessment (Behavioral)
Mild Cognitive Impairment patients
干预措施: Structural MRI (Other)
结局指标
主要结局
Rate of volume change of whole brain and other structural MRI measures
时间窗: 1 Month
Cerebral regions implicated in prospective memory observed by functional MRI
时间窗: 1 Month
Episodic memory as measured by Cognitive Tests
时间窗: 18 Months
Virtual reality evaluation of prospective memory
时间窗: 1 Month
Group differences for each imaging and neuropsychological measurement
时间窗: 1 Month
次要结局
未报告次要终点