Safety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Amyloid burden range in all subjects
研究概览
简要总结
To evaluate the potential contribution of amyloid burden, as indexed by 11C-Pittsburgh compound B (PiB) retention, to the progression of cognitive impairments in patients with Parkinson's disease(PD).
详细描述
Study design:
Multi-center, Five-arm
Subjects:
Patients with PD without dementia; Patients with PD with mild cognitive impairment (MCI); Patients with PD with dementia; Patients with a dementia with Lewy bodies(DLB); Healthy person
Sample size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Parkinson's disease and parkinsonian dementia syndromes
- •Males and females, ≥40 years old
- •The diagnosis of PD is established using the UK Parkinson's Disease Society Brain Bank Research Center Clinical diagnostic criteria. Criteria for PD-MCI and PD-dementia are consistent with those of the Movement Disorder Society. The DLB Consortium consensus criteria are used for DLB.
- •They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.
排除标准
- •Females planning to bear a child recently or with childbearing potential
- •Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
- •Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- •Known severe allergy or hypersensitivity to IV radiographic contrast.
- •Patients not able to enter the bore of the PET/CT scanner.
- •Inability to lie still for the entire imaging time because of cough, pain, etc.
- •Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- •Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
研究组 & 干预措施
PD without dementia
11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.
干预措施: 11C-PiB (Drug)
PD with MCI
11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.
干预措施: 11C-PiB (Drug)
PD with dementia
11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.
干预措施: 11C-PiB (Drug)
dementia with Lewy bodies
11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.
干预措施: 11C-PiB (Drug)
healthy control
11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.
干预措施: 11C-PiB (Drug)
结局指标
主要结局
Amyloid burden range in all subjects
时间窗: 1 week
Outcome Measures: All patients underwent a 90-min dynamic 11C-PIB PET scan. 11C-PiB distribution volume ratio (DVR) will be estimated by using the PMOD software.
次要结局
- The cognitive scores in all patients(0, 6month, 1year)