NCT03156647已完成不适用
Alpha-synuclein Level in the Saliva as a Potential Diagnostic Aid to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome
Centre Hospitalier Universitaire de Nīmes3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Compare saliva level of oligomeric alpha-synuclein between two groups of patients wth classical parkinsonian: patients with idiopathic Parkinson disease and patients with a acquired parkinsonian syndrome from anti-dopamine treatment.
研究概览
简要总结
The aim of this study is to determine whether a significant reduction in the total level of alpha-synuclein and significant increase in the oligomeric form of alpha-synuclein and therefore the ratio oligomeric:total alpha-synuclein occurs in patients with Parkinson disease compared to patients with drug-induced parkinsonian syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The subject is participating in another study
- •The subject is in an exclusion period determined by a previous study
- •The patients is under judicial protection
- •The subject or their representative refused to sign the consent form
- •It proves impossible to give the subject or their representative clear information.
- •Patients with atypical degenerative parkinsonian syndrome
- •Patients with vascular, post-traumatic, metabolic, toxic or genetic parkinsonian syndrome
- •Appearance of parkinsonian syndrome prior to treatment with anti-dopamine
- •Injection of botulinum toxin into the salivary glands
- •Contra-indication on DAT-scan (unbalanced dysthyroidism, allergy, treatment with bupropion or amphetaminergics)
- •Poor oral health (polyposis, gingivostomatitis) observed during the odontologist visit
- •Patients not taking anti-psychotics with parkinsonian syndrome and normal DAT-scan
结局指标
主要结局
Compare saliva level of oligomeric alpha-synuclein between two groups of patients wth classical parkinsonian: patients with idiopathic Parkinson disease and patients with a acquired parkinsonian syndrome from anti-dopamine treatment.
时间窗: Day 0
次要结局
- UPDRS II-III-IV score(Day 0)
- UDysRs score(Day 0)
- character of parkinsonian syndrome(Day 0)
- akathisia(Day 0)
- questionnaire on non-motor symptoms in Parkinson disease(Day 0)
- Perform the first estimation of discriminatory capacity of saliva levels of oligomeric alpha-synuclein for diagnostic differentiation between idiopathic Parkinson disease and anti-dopamine induced acquired parkinsonian syndrome.(Day 0)
- Compare levels of total alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein between the two groups(Day 0)
- Perform the first estimation of discriminatory capacity of saliva levels of total oligomeric alpha-synuclein and the ratio of oligomeric alpha-synuclein:total alpha-synuclein for diagnostic differentiation between two groups(Day 0)
- Creation of a biobank with remaining samples(Day 0)
- neuro-psychological evaluation(Day 0)
- GDS score(Day 0)
- interogation to determine extent of motor and non-motor clinical markers to differentiate the two groups(Day 0)
研究者
研究点 (3)
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