NL-OMON55477已完成4 期
evodopa in early Parkinson*s disease;LEAP-5Y-study: Follow-up of the Levodopa in early Parkinson's disease study - LEAP-study;LEAP-5Y-study: Acroniem follow-up trial: LEAP-5Y-study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 446
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The inclusion criteria are:
- •* idiopathic PD (13) with bradykinesia and at least two of the following signs:
- •* resting tremor;
- •* rigidity;
- •* asymmetry.
- •* newly diagnosed PD within the past two years;
- •* age 30 years and over;
- •* a life expectancy of more than two years;
- •* no limitations in functional health for which the patient needs
- •PD-medication., LEAP-5Y-study:
- •* Participation in the LEAP-study
- •* Patients that gave permission to be contacted about a follow-up study
排除标准
- •The exclusion criteria are:
- •* tremor as most prominent symptom, such as (13):
- •* a severe resting tremor that is present (almost) continuously;
- •* tremor of medium to large amplitude which results in functional disability
- •(such as interfering with feeding)
- •* previous treatment with PD-medication, e.g., levodopa, DA, MAO-B-inhibitor,
- •catechol-O-methyl transferase-inhibitor (COMT-inhibitor), or amantadine;
- •* cognitive impairments, i.e., Mini Mental State Examination (MMSE) of 23
- •points or lower (14);
- •* more than 28 points on the Beck Depression Scale II (BDI-II) (15);
- •* diagnosis of depression by a psychiatrist in the last year;
- •* history of psychosis;
- •* the presence of signs indicating atypical or secondary parkinsonism such as:
- •* the use of drugs that may cause parkinsonism (e.g., metoclopramide,
- •cinarizine, anti-psychotics, natrium-valproate, lithium, amiodarone);
- •* metabolic disorders (e.g., Wilson*s disease);
- •* encephalitis;
- •* vascular parkinsonism;
- •* repeated head-trauma., * untreated closed-angle glaucoma;
- •* alcohol abuse;
- •* pregnancy
- •* legally incompetent adults;
- •* inability to provide written informed consent., LEAP-5Y-study:
- •* Inability to provide written informed consent
- •* Legally incompetent adult
研究者
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