NCT02664571撤回不适用
Evaluation of Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- PET scan with Florbetaben: Standardized Uptake Value Ratio
研究概览
简要总结
The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ: FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis in non-demented patients with that observed in healthy subjects, patients with ACA and with lobar hematoma(s) and patients with Alzheimer's dementia without MRI signs in favor of ACA.
详细描述
The secondary objectives of this study are to compare among groups:
A. The associated micro-bleeds. B. Associated leukoencephalopathy. C. Contrast observed in lobar Virchow-Robin perivascular spaces. D. Apolipoprotein E genotypes.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients with amyloid cerebral angiopathy with isolated hemosiderosis:
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient has a single or multiple focal spontaneous hemosiderosis objectified by an MRI
- •The patient is does not have dementia (Mini Mental State score> 27)
- •Inclusion Criteria for patients with amyloid cerebral angiopathy with with lobar hematoma(s):
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient has one or more spontaneous lobar hematomas with or without hemosiderosis objectified by an MRI
- •The patient is does not have dementia (Mini Mental State score> 27)
- •Inclusion Criteria for patients with Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy:
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient has Alzheimer's dementia (Mini Mental State score <24) without hemosiderosis or previous lobar hematoma or history of other brain lesion seen on MRI
- •Inclusion Criteria for health volunteers:
- •The subject must have given his/her informed and signed consent
- •The subject must be insured or beneficiary of a health insurance plan
- •Healthy volunteers without cerebral neurological history and with normal MRI
- •The subject is does not have dementia (Mini Mental State score> 27)
排除标准
- •for patients with amyloid cerebral angiopathy with isolated hemosiderosis:
- •The patient is participating in another interventional study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection
- •The subject (next of kin or legal representative) refuses to sign the consent
- •It is not possible to give the subject or his/her representative informed information
- •The patient has an contra-indication for performing an MRI
- •The patient is in the acute phase (the tracer does not bind in cases of large hematoma)
- •Exclusion Criteria for patients with amyloid cerebral angiopathy with with lobar hematoma(s):
- •The patient is participating in another interventional study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection
- •The subject (next of kin or legal representative) refuses to sign the consent
- •It is not possible to give the subject or his/her representative informed information
- •The patient has an contra-indication for performing an MRI
- •The patient is in the acute phase (the tracer does not bind in cases of large hematoma)
- •Exclusion Criteria fpr patients with Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy:
- •The patient is participating in another interventional study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection
- •The subject (next of kin or legal representative) refuses to sign the consent
- •It is not possible to give the subject or his/her representative informed information
- •The patient has an contra-indication for performing an MRI
- •The patient is in the acute phase (the tracer does not bind in cases of large hematoma)
- •Haemosiderosis or history of lobar hematoma or other visible cerebral history on MRI
- •Exclusion Criteria for healthy volunteers:
- •The subject is participating in another interventional study
- •The subject is in an exclusion period determined by a previous study
- •The subject is under judicial protection
- •The subject (next of kin or legal representative) refuses to sign the consent
- •It is not possible to give the subject or his/her representative informed information
- •The subject has an contra-indication for performing an MRI
- •Abnormal MRI
- •The groups will be matched according to sex and age (by increments of 5 years) to the extent possible. Because amyloid cerebral angiopathy is a very rare condition, matching the two factors may be difficult to achieve. We therefore anticipate where appropriate to focus matching on age.
结局指标
主要结局
PET scan with Florbetaben: Standardized Uptake Value Ratio
时间窗: Day 0
次要结局
- On the reference MRI: The presence/absence classification for superficial siderosis(Day 0)
- On the reference MRI: the number of lobar hemorrhages(Day 0)
- On the reference MRI: the absolute quantitative count of microbleeds(Day 0)
- On the reference MRI: The predominant location of microbleeds(Day 0)
- On the reference MRI: the locations of superficial siderosis(Day 0)
- On the reference MRI: microbleed count category(Day 0)
- On the reference MRI: the locations of lobar hemorrhages(Day 0)
- On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale(Day 0)
- Apolipoprotein E genotype(Day 0)
研究者
研究点 (4)
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