NCT00817726进行中（未招募）不适用
A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Identify the key cognitive and non-motor characteristics for early PD diagnosis
研究概览
简要总结
- Purpose - to validate a combination of biological and clinical markers in the rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the pre-symptomatic stage of Parkinson's disease (PD).
- Procedures - All subjects (RBD diagnosis and controls) will have 1) a medical and neuro history and physical including videotape of movements, 2) neuropsychological testing, 3) a sleep study, 4) olfactory testing, 5) blood draw for serum testing , 6) functional MRI. All of these procedures are often performed clinically in the diagnosis of PD. Enrollment of subjects with PD is complete. Any testing performed prior to enrollment as part of the clinical evaluation may be used in place of repeating the procedure for the study. Subjects will be followed for 5 years. It is hypothesized that a 5 year follow up may capture a significant number of pre-Parkinson's subjects who will be diagnosed. Subjects may be offered a repeat enrollment after 5 years.
详细描述
Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •35-70 year old men & women
- •(1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control with a non-neurodegenerative disorder, age and gender-matched to (1)
- •Gives written informed consent
- •Pregnant women are not excluded, but will be identified by HCG.
排除标准
- •a A diagnosis of any non-Parkinsonian Neurodegenerative Disease.
- •b. Any unstable or uncontrolled medical or psychiatric condition.
- •c. Parasomnia or RBD not idiopathic, eg., secondary to metabolic derangement or medicine effect.
- •d. Renal (creatinine over 1.6) or hepatic insufficiency (LFT significantly out of range), or a history of significant uncontrolled cardiac disease.
- •e. Significant dementia (MMSE<25 of 30 or MOCA<25/30) that would interfere with study procedures or informed consent.
- •f. Any reason which, in the opinion of the PI, would increase the risk or decrease the value of any study procedure.
- •g. fMRI will not be performed for anyone for whom the screening questionnaire indicates is ineligible for MRI imaging.
结局指标
主要结局
Identify the key cognitive and non-motor characteristics for early PD diagnosis
时间窗: 5 years
periodically performed set of clinical and imaging parameters suspected to be linked to PD to see if, as a group, these parameters could identify those at risk for motor symptoms of PD before these symptoms develop.
次要结局
- Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients.(5 years)
- functional MRI of the brain and eye tracking testing, identification of distinct features in PD(beginning of study and at 2 years)
- identify key fluid-based PD-associated molecular markers that identify disease state or progression(5 years)
研究者
Mya Schiess
Professor - Neurology
The University of Texas Health Science Center, Houston
研究点 (1)
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