NCT02839187已完成不适用
Neuro Imaging and Multimodal Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- fixing the AV-45 during PET
研究概览
简要总结
The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients, who responded to strict physiological criteria typical of AD pathology. The objective of the present study was to identify the earliest alterations in cerebral connections that could contribute to the initial episodic memory impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all subjects :
- •Capacities visual, auditory (authorized devices) and oral or written expression sufficient for the proper performance of tests
- •Obtain informed written consent of the subject
- •Patients with AD :
- •Outpatient accompanied by a "helping"
- •No parenchymal lesions allowing isolation explain the symptoms on brain MRI (T1 and T2) carried more than 6 months prior to enrollment in the study. Patients with more than three hyperintense white matter or visible lacunar infarction or T2 FLAIR will not be included in the study.
- •probable Alzheimer's disease diagnosis par with international standards
- •Illness in a mild stage (CDR 1, 24 ≥ Mini-Mental State Examination (MMSE)> 18)
- •activity of daily living (ADL) 4 items> 1/4
- •Patients with Alzheimer's disease at a pre-dementia stage:
- •Alzheimer's Diagnosis pre-dementia based on the search criteria
- •Illness in a mild stage (CDR 0.5, 30 ≥ MMSE ≥ 25)
- •ADL items ≤ 4 1/4
- •Control subjects :
- •30 ≥ MMSE ≥ 27
- •perfect autonomy in daily living (IADL = 0, CDR = 0)
- •Neuropsychological evaluation not highlighting of impaired cognitive performance with focus on memory performance
- •No parenchymal lesions on brain MRI.
- •Lack of family history (first degree) of Alzheimer's disease
排除标准
- •Subjects with a contra-indication to MRI (carrying a pacemaker or cardiac defibrillator, implanted a material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid artery , holders of orthopedic implants, claustrophobia)
- •Subjects with clinically significant gastrointestinal, renal, hepatic, endocrine, or cardiovascular
- •Subjects with a psychiatric disorder or progressive neurological
- •French Language level insufficient to be appropriately involved in neurophysiological evaluation
- •less than 5 years Education (insufficient understanding level to participate in the study)
- •Administrative problems: unable to give informed about information, not covered by a social security system
- •Hypersensitivity to the active substance or to any of the excipients
- •unbalanced diabetes mellitus
- •Subjects treated by a non-steroidal anti-inflammatory
结局指标
主要结局
fixing the AV-45 during PET
时间窗: baseline
compare fixing the AV-45 during a examination emission tomography (PET) between three different groups: healthy subjects, patients with Alzheimer's disease and a mild stage patients of Alzheimer's disease at a pre-dementia stage
次要结局
- Deposition of amyloid protein(baseline)
- Standard Cognitive function(Baseline)
- Specific memory evaluation(Baseline)
研究者
研究点 (2)
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