Amyloid Accumulation After Mild Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.
研究概览
简要总结
There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago and GCS=13-15 will be recruited. Another group of 200 participants with the same age and gender and without TBI will be recruited as the controls. All of them will undergo AD8 questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2. 10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for AV45 amylid PET study.
There will also be 10 participants without traumatic brain injury and interested in this study, aged 55 years or older better.
详细描述
We will examine the mTBI patients in a long-term follow-up manner by cognitive tests and A-PET. This is a novel study for linking mTBI and AD by solid, reliable methods, in terms of A-PET and cognitive function tests. In addition, we will figure out the importance of APOE genotypes for amyloid accumulation and cognitive impairment. These results should shed light on the further clinical studies and amyloid-cleaning therapy for prevention and treatment for dementia after mTBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alzheimer disease after mild traumatic brain injury
Based on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio
干预措施: [18F]AV-45 PET amyloid binding imaging (Drug)
mild traumatic brain injury without Alzheimer disease
To recruit patients 1, 5, 10, 15 years after mTBI with or without cognitive impairment and age-gender-matched controls (a total of 3 groups) for amyloid- positron emission tomography (A-PET)
干预措施: [18F]AV-45 PET amyloid binding imaging (Drug)
Normal control
People aged 30 or older without mTBI or AD
干预措施: [18F]AV-45 PET amyloid binding imaging (Drug)
结局指标
主要结局
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.
时间窗: one year
The amyloids load (based on F-18-AV-45 binding) in brain among mild traumatic brain injury and controls in a temporal manner.
次要结局
- F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls(one year)