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临床试验/NCT00917709
NCT00917709已完成不适用

In Vivo SPECT Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies: Applying in Diagnostic and Identification of Pathological Subtypes.

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2009年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Binding Potential (BP) quantification of each radioligand

研究概览

简要总结

The general aim of this research project is to determine the relationships between alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral features of dementias with Lewy bodies (DLB).

Both clinical and neurochemical data support the view that DLB is not a homogeneous entity and it can be hypothesized that differential alterations of central ACh systems (i.e. anterior vs posterior vs striatal interneurons) in association or not with a DA nigrostriatal dysfunction could partly support the clinical heterogeneity observed in this disease. ACh in vivo imaging has been relatively underutilized to date and to our knowledge only on the postsynaptic side. Furthermore, ACh/DA interactions and their relationships with the symptomatology of DLB and related pathologies (PDD) had never been investigated.

详细描述

Neurochemical investigations and observations suggest a crucial physiopathological role of central ACh systems in dementias with Lewy bodies (DLB). Alterations of cholinergic neurons could be involved in the general cognitive decline (central feature) but also in fluctuating attentional performances and rapid eye movement sleep disorder as it was shown in thalamus.

Post synaptic in vivo SPECT imaging recently demonstrated an increase in muscarinic receptors in DLB patients in the occipital cortex that could be associated with the visuospatial dysfunction often reported in DLB or even in visual hallucinations.From a pharmacological point of view, the involvement of ACh systems in DLB is confirmed by the consistently reported efficacy of cholinesterase inhibitor therapy, considered as greater than in AD.

Concerning DA systems, presynaptic in vivo SPECT imaging studies of DA transporter have shown a decreased striatal uptake in DLB patients, different when compared with Parkinson's disease patients or Alzheimer's disease patients.

Strategy, procedure In this project we will use for the first time in vivo molecular imaging of presynaptic molecular target of ACh systems (VAChT) with [123I]-iodobenzovesamicol and of DA systems (DAT) with DATSCAN in order to better analyse the link between neurobehavioral profiles of patients and a differential alteration of ACh/DA systems in DLB.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients: man or woman probable DLB, with and without extrapyramida syndrome
  • Healthy subjects: man or woman with no neuropsychiatric disorders

排除标准

  • Diagnostic or therapeutic irradiation during the 12 months before SPECT imaging
  • Age less than 18 and more than 90
  • Iodine sensibility
  • Brain-vascular disease, severe brain injury, type I and II diabetes mellitus, thyroid dysfunction, chronic alcoholism
  • Pregnant and breast feeding women, women in age to procreate
  • Impossibility to undergo MRI study (pace-maker, claustrophobia)
  • Persons under guardianship, outside state to express their assent or in emergency situation
  • Healthy subjects: cognitive impairment, dementia

研究组 & 干预措施

DLB without extrapyramidal syndrome

Other

patients dementia with Lewy bodies without extrapyramidal syndrome

干预措施: neuropsychological evaluation (Behavioral)

healthy volunteers

Sham Comparator

healthy volunteers

干预措施: Imaging with IBVM (Other)

healthy volunteers

Sham Comparator

healthy volunteers

干预措施: Imaging with DATSCAN (Other)

healthy volunteers

Sham Comparator

healthy volunteers

干预措施: neuropsychological evaluation (Behavioral)

DLB with extrapyramidal syndrome

Experimental

patients dementia with Lewy bodies with extrapyramidal syndrome

干预措施: Imaging with IBVM (Other)

DLB with extrapyramidal syndrome

Experimental

patients dementia with Lewy bodies with extrapyramidal syndrome

干预措施: Imaging with DATSCAN (Other)

DLB with extrapyramidal syndrome

Experimental

patients dementia with Lewy bodies with extrapyramidal syndrome

干预措施: neuropsychological evaluation (Behavioral)

DLB without extrapyramidal syndrome

Other

patients dementia with Lewy bodies without extrapyramidal syndrome

干预措施: Imaging with IBVM (Other)

DLB without extrapyramidal syndrome

Other

patients dementia with Lewy bodies without extrapyramidal syndrome

干预措施: Imaging with DATSCAN (Other)

结局指标

主要结局

Binding Potential (BP) quantification of each radioligand

时间窗: Day 1 ; Day 1 and between day 14 to 28

次要结局

  • Ratio dopaminergic system/cholinergic system Binding Potential(Day 1 and between day 14 to 28)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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