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

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 4

Conditions: Drug-naïve Patients With Parkinson's Disease; Apathy

Treatments: Drug: Placebo; Drug: AZILECT®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01765257

2007-002800-16

CHU-0138

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

rasagiline

Experimental group

Description:

Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France

Treatment:

Drug: AZILECT®

placebo

Placebo Comparator group

Description:

Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France

Treatment:

Drug: Placebo