NCT01860118已完成不适用
LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- Biomarkers
研究概览
简要总结
This proposal seeks to 1) determine whether there are biomarkers associated with Parkinson's disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients versus controls, and 2) to determine if LRRK2 expression and/or phosphorylation are significantly lowered in the exosomes of individuals treated with the potent LRRK2 kinase inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target effects for future LRRK2 inhibitor clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's disease inclusion criteria:
- •Inclusion criteria will be based on UK Brain Bank criteria for the clinical diagnosis of PD. These require 1) the presence of bradykinesia and either rest tremor or rigidity; 2) asymmetric onset; 3) progressive motor symptoms 4) age at onset 21-99 years.
- •Control inclusion criteria: ages of between 21-99 years, a lack of PD in first-degree blood relatives, and a lack of positive responses on more than 3 items on the PD Screening Questionnaire.
排除标准
- •For all subjects:
- •include atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, History of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (< 5 years), dementia, known severe anemia (hematocrit <30), history of kidney disease and/or current or past glomerular filtration rate (GFR) <60 possibly indicative of kidney disease, or a serious comorbidity that may interfere with participation in the study.
结局指标
主要结局
Biomarkers
时间窗: up to 3 years
Biomarkers associated with Parkinson's disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients versus controls.
次要结局
- LRRK2 expression and/or phosphorylation(up to 3 years)
研究者
Andrew B. West
Associate Professor
University of Alabama at Birmingham
研究点 (1)
Loading locations...
相似试验
终止
不适用
Characteristics of Parkinson s Disease Associated With the LRRK-2 Gene MutationParkinson DiseaseNCT00467090National Institute of Neurological Disorders and Stroke (NINDS)34
Unknown
不适用
New Biomarkers in Parkinson's DiseaseParkinson DiseaseNCT05150158Neuromed IRCCS60
Unknown
不适用
Identifying New Biomarkers of Parkinson's From Routine Brain ImagingParkinson DiseaseNCT04986020University of Plymouth20,000
招募中
不适用
Molecular and Functional Imaging in Monogenic PD.Nervous System DisorderNeurodegenerative DiseasesNeurodegenerative Disease, HereditaryParkinson'sParkinson DiseaseNCT05518617University of Exeter45
已完成
不适用
Biological Markers in Parkinson's DiseaseParkinson DiseaseNCT00088335National Institute of Neurological Disorders and Stroke (NINDS)90