NCT02786667

Non Motors Aspects in De Novo Parkinson's Disease

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 30 Years – 72 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parkinson Disease
• Apathy

Interventions

Type	Name	Description
DRUG	Rotigotine	6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
DRUG	Placebo	6 months treatment with Placebo up to 8 mg per day with a titration period for one month

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-10-15
• Completion: 2017-12-01
• First posted: 2016-06-01
• Last updated: 2017-10-26

Locations

1 site across 1 country: France