evodopa in early Parkinson*s disease;LEAP-5Y-study: Follow-up of the Levodopa in early Parkinson's disease study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 446

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical outcome measure is the difference in the mean total UPDRS<br /><br>scores between the early and delayed groups at 80 weeks.<br /><br><br /><br>Ancillary diagnostic accuracy study:<br /><br>The primary outcome measure is the diagnostic accuracy of the different<br /><br>parameters of neurological examination, which will be expressed in terms of<br /><br>sensitivity, specificity and predictive values.<br /><br><br /><br>LEAP-5Y-study:<br /><br>The difference between the mean total UPDRS score of the early- and delayed<br /><br>start group of the LEAP-study, measured 5 years after baseline of the<br /><br>LEAP-study.</p><br>

Secondary Outcome Measures