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.
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: 1. 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. 2. 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). 3. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
199
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
University Hospital of Grenoble
Grenoble, France
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
Time frame: 6 months
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