Non Motors Aspects in De Novo Parkinson's Disease
- Registration Number
- NCT02786667
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 199
- Patients with Parkinson disease without treatment for Parkinson disease
- Recent diagnosis (< 2 years)
- Without cognitive troubles
- Patients with cognitive troubles
- Treated patients with L-Dopa or Dopamine agonists
- Other severe illness
- Pregnant or parturient woman
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 6 months treatment with Placebo up to 8 mg per day with a titration period for one month Rotigotine Rotigotine 6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
- Primary Outcome Measures
Name Time Method Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital of Grenoble
🇫🇷Grenoble, France
University Hospital of Grenoble🇫🇷Grenoble, France