Non Motors Aspects in De Novo Parkinson's Disease

Study Overview
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Brief Summary
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Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease. Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.

Detailed Description
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This study aims to show the impact of a treatment with a D2/D3 receptor-specific dopamine agonist on the hypo-dopaminergic syndrome and quality of life of patients with de-novo Parkinson's disease. The study consists of three parts: The first part consists of a detailed clinical description of these patients, focusing on neuropsychological symptoms. The objective is to describe patients with and without apathy and hypo-dopaminergic syndrome. From this population, a small number of patients with and without hypo-dopaminergic syndrome will be selected in order to compare serotoninergic and dopaminergic denervation by positron emission tomography (PET). In patients with hypo-dopaminergic syndrome the motivational effects of a dopamine agonist will be tested in a randomized, double-blind, placebo-controlled study. We hypothesize a significant improvement of apathy in the rotigotine group versus placebo

Official Title
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Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.

Conditions
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Parkinson Disease, Apathy

Intervention / Treatment
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* Drug: Rotigotine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Parkinson disease without treatment for Parkinson disease Recent diagnosis (< 2 years) Without cognitive troubles Exclusion Criteria: Patients with cognitive troubles Treated patients with L-Dopa or Dopamine agonists Other severe illness Pregnant or parturient woman

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotigotine<br>6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month | Drug: Rotigotine<br>* 6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month<br>* Other names: Neupro;|
| Placebo Comparator: Placebo<br>6 months treatment with Placebo up to 8 mg per day with a titration period for one month | Drug: Placebo<br>* 6 months treatment with Placebo up to 8 mg per day with a titration period for one month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group |  | 6 months |