JPRN-jRCTs031180446已完成未知
Clinical study of the diagnostic impact of florbetapir (18F) in amyloid imaging - AMY-DI
Okita Kyoji0 个研究点目标入组 119 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 119
研究概览
简要总结
The result suggests that amyloid PET scan has a significant impact on making diagnosis and setting clinical plans. Thus, amyloid PET scan may help making clinical practice more sufficient.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •Cohort 1: Patients with cognitive impairment in whom Alzheimer's disease is suspected (1).
- •1. In reference to each diagnostic criterion, the following diseases/states are suspected:
- •1)Mild cognitive impairment
- •2)Alzheimer's disease
- •3)Dementia with Lewy bodies
- •4)Vascular dementia
- •5)Behavioral variant of frontotemporal dementia
- •6)Primary progressive aphasia
- •7)Semantic dementia
- •8)Depression
- •9)Idiopathic normal pressure hydrocephalus
- •10)Progressive supranuclear palsy
- •11)Corticobasal degeneration
- •12)Epilepsy
- •(1: The diagnostic confidence for Alzheimer's disease as the cause of the cognitive impairment falls within the range of 15%-85% according to the physician in charge)
- •2. Patients having the ability to provide informed consent. When it is difficult to obtain it from the patient, consent is provided by the proxies.
- •3. Prior head MRI scan within 90 days as a clinical routine
- •Cohort 2: Healthy volunteers with normal cognitive function
- •1)Of Japanese origin, aged between 35 and 50 years old (both sexes are allowed)
- •2)With a score of 29 or more in the mini-mental state examination (MMSE). Subjects are judged to have normal cognitive function according to their medical history and neurocognitive test battery at screening.
- •3)Who provided informed consent
排除标准
- •1. Prior history of amyloid PET scan in other clinical studies or trials
- •2. Severe dementia with a score of 19 points or less in the MMSE
- •3. Typical symptoms and course of the disease, with a clear clinical diagnosis of one of the following:
- •1)Alzheimer's disease
- •2)Dementia with Lewy bodies
- •3)Vascular dementia
- •4)Behavioral variant of frontotemporal dementia
- •5)Primary progressive aphasia
- •6)Semantic dementia
- •7)Depression
- •8)Idiopathic normal pressure hydrocephalus
- •9)Progressive supranuclear palsy
- •10)Corticobasal degeneration
- •4. Asymptomatic
- •5. No objective cognitive dysfunction
- •6. Person judged to be inappropriate to perform amyloid PET examination by investigator in charge
- •1. Pregnant women and lactating mothers
- •2. Who has a cardiac pacemaker, metals in the body, or a tattoo
- •3. Who has claustrophobia
研究者
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