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临床试验/NCT01865877
NCT01865877已完成不适用

Motor, Non-motor and Genetic Determinants of Progression and Complications in Parkinson's Disease: A Multicenter Cohort Study in Mexican Population (ReMePArk)

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez6 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
550
试验地点
6
主要终点
To assess motor scale change over time

研究概览

简要总结

The objective of the study is to assess the effect of motor, non-motor and genetic factors on the progression of Parkinson's disease as well as its impact on complications rates.

A large sample of Mexican subjects with Parkinson's disease attending several referral centers will be included.

Data collected will include disease severity and motor scales, non-motor scales as well as genotyping for monogenic forms of the disease.

Assessments will be performed every 6 months for two years.

详细描述

Demographic and clinical data will be collected after obtaining a signed informed consent.

Recruitment will be competitive. Data collected includes age, gender, motor phenotype, age at onset, age at diagnosis, smoking history, family history, antiparkinsonic treatment, other treatments and a complete neurological evaluation.

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
20 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Parkinson's disease by the United Kingdom Parkinson's disease Society Brain Bank Criteria
  • Any gender
  • Any Hoehn and Yahr stage
  • Written informed consent

排除标准

  • Severe comorbidity that may limit proper neurological evaluation as judged by the investigator
  • Subjects with atypical or secondary parkinsonism

结局指标

主要结局

To assess motor scale change over time

时间窗: Every 6 months for 2 years

Motor symptoms will be assessed by proper and validated motor scales; also minimal clinically important change will be determined.

次要结局

  • To assess caregiver burden as disease progresses(Every 12 months for 2 years)
  • To assess quality of life change over time.(Every 6 months for 2 years)
  • To assess non-motor symptoms over time(Every 6 months for 2 years)

研究者

发起方
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amin Cervantes-Arriaga

MD, MSc

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

研究点 (6)

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