Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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.

Conditions
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Drug-naïve Patients With Parkinson's Disease, Apathy

Intervention / Treatment
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* Drug: AZILECT®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Drug-naïve patients with Parkinson's disease (UKPDBB criteria) No dementia (Mattis dementia rating scale > 130; Mini Mental Sate Examination ≥26) No depression (MADRS < 15) Criteria of apathy from Robert et al (2009) At least mild apathy (≥-21 to Lille Apathy Rating Scale) Age : 35-70 y Affiliation to social security Agreement of patients Exclusion Criteria: - Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included. Ongoing severe psychiatric or somatic diseases Others treatments : antipsychotics antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion) psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid) any contra-indication according to SmPC patients under guardianship Women without efficient contraception Person who participate to an other study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rasagiline<br>Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France | Drug: AZILECT®<br> <br> |
| Placebo Comparator: placebo<br>Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lille Apathy Rating Scale (LARS) score |  | at the visit 3 (after 3 months of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor assessment : Unified Parkinson's Disease Rating Scale |  | at the visit 3 (after 3 months of treatment) | 
| Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale |  | at the visit 3 (after 3 months of treatment) | 
| Self assessment of apathy : Starkstein |  | at the visit 3 (after 3 months of treatment) | 
| Quality of life : PDQ 39 |  | at the visit 3 (after 3 months of treatment) | 
| Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery |  | at the visit 3 (after 3 months of treatment) | 
| Hyperdopaminergic symptoms : Parkinson's disease behavioral scale |  | at the visit 3 (after 3 months of treatment) | 
| Fatigue assessment : Parkinson Fatigue Scale |  | at the visit 3 (after 3 months of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-naïve patients with Parkinson's disease, Apathy, Rasagiline