Identification of Risk Factors Parkinson's Disease by Convergence Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,220
- 试验地点
- 1
- 主要终点
- Significant variations in the frequencies of gene polymorphisms and the risk of developing Parkinson's disease
研究概览
简要总结
Using this convergence approach from a limited group of subjects with non-diseased controls, patients with Parkinson's disease or related diseases, we will be able to limit the number of potential genes of specific susceptibility to Parkinson disease. These genes will then be studied using a case-control genetic epidemiology approach. The risk of developing the disease will then be evaluated according to clinical, biological and environmental variables collected in Parkinson's subjects and healthy controls in the second group of subjects. The specificity of the genetic associations found will be evaluated in subjects with Parkinson's disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for Parkinson's patients and "related diseases" controls:
- •Parkinsonian patients meeting the Gelb criteria
- •Patients with other neurodegenerative disease (such as other Parkinson syndrome or synucleopathies) meeting the criteria set out in Appendix 2 (Lewy Bodies dementia, Parkinson's disease with dementia, MultiSystem atrophy, Progressive Supranuclear Paralysis) , Amyotrophic Lateral Sclerosis, Restless Legs Syndrome, Alzheimer's Disease).
- •Woman of childbearing age having an effective means of contraception.
- •Informed consent signed by the subject or his legal representative.
- •For demented subjects coming for consultation or day hospitalization with an accompanying person, signature of the legal representative.
- •Criteria for inclusion of non-ill controls:
- •Absence of rest trembling, bradykinesia and stiffness
- •MMSE (Mini Mental State Examination) greater than 25
- •Woman of childbearing age having an effective means of contraception.
- •subject having signed the informed consent.
- •No family history of neurodegenerative disease that started before age
- •These controls will not present any Parkinsonian signs during the clinical evaluation. They may have functional disabilities whose cause is known and unrelated to a neurodegenerative disease with a cognitive function measurement greater than 25 in the MMSE test.
排除标准
- •Criteria for non-inclusion of patients:
- •Clinical criteria for exclusion of the diseases described
- •Participation in another therapeutic trial or in the exclusion period of a previous clinical trial.
- •Criteria for non-inclusion of non-ill controls:
- •Functional discomfort in daily life of unknown cause
- •MMSE less than 25
- •Participation in another therapeutic trial or in the exclusion period of a previous clinical trial.
结局指标
主要结局
Significant variations in the frequencies of gene polymorphisms and the risk of developing Parkinson's disease
时间窗: through study completion, an average of 10 years
the frequency is measured according to biological and environmental variables modulating the risk of developing Parkinson's disease.
次要结局
未报告次要终点