Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
Overview
- Phase
- Phase 3
- Intervention
- Rotigotine
- Conditions
- Parkinson Disease
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 199
- Locations
- 1
- Primary Endpoint
- Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Rotigotine
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
Intervention: Rotigotine
Placebo
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Intervention: Placebo
Outcomes
Primary Outcomes
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
Time Frame: 6 months