Apathy Clinical Trial
Official title:
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.
Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD)
and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the
neuropathological bases of apathy are still unknown. However, recent data suggests that
apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.
Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the
MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in
Parkinson's disease.
The primary outcome is to demonstrate a significant reduction of apathy using the Lille
apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease,
using a treatment by rasagiline.
Study design :
Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization
1/1). Duration 3 months 16 recruiting centers in France
Population :
50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with
placebo and 25 patients with rasagiline.
3 visits
- Visit 1 : inclusion / randomisation/ first study medication dispensation
- Visit 2 (1.5 month after V1) : first evaluation and second study medication
dispensation.
- Visit 3 (3 months after V1, final visit) : second evaluation
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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