NCT01565356已完成不适用
Comparison of PET Images Acquired at 30 Min and 50 Min Post Injection of 18F-AV-45 in Healthy Volunteers and Alzheimer's Disease Patients
Avid Radiopharmaceuticals0 个研究点目标入组 41 人开始时间: 2010年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation
研究概览
简要总结
This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).
- •Inclusion Criteria (AD group):
- •Greater than 50 years of age
- •Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- •Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
- •History of cognitive decline gradual in onset and progressive over a period of at least 6 months
- •Inclusion Criteria (A01[NCT01565291] healthy volunteer group):
- •50 years of age, inclusive
- •MMSE of 29 or greater
- •Inclusion Criteria (A03[NCT01565330] healthy volunteer group):
- •35 to 55 years of age, inclusive
- •MMSE of 29 or greater
排除标准
- •(both groups):
- •Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
- •Diagnosis of other dementing / neurodegenerative disease
- •Diagnosis of mixed dementia
- •Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
- •Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
- •Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
- •Clinically significant psychiatric disease
- •History of epilepsy or convulsions
- •Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- •Current clinically significant cardiovascular disease
- •Received investigational medication within the last 30 days
结局指标
主要结局
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation
时间窗: Scans acquired 30-40 min and 50-60 min after injection
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.
次要结局
- Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation(Scans acquired 30-40 min and 50-60 min post-injection)
研究者
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