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

Summary

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.

Conditions

• Drug-naïve Patients With Parkinson's Disease
• Apathy

Interventions

DRUG

AZILECT®

DRUG

Placebo

Sponsors & Collaborators

• H. Lundbeck A/S

  collaborator INDUSTRY

• CHU Purpan (Toulouse)

  collaborator UNKNOWN

• Hôpital Haut-Lévêque

  collaborator OTHER

• Centre Hospitalier de la côte Basque

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• CHU de Rennes (Rennes)

  collaborator UNKNOWN

• University Hospital, Lille

  collaborator OTHER

• Hôpital Dupuytren

  collaborator OTHER

• University Hospital, Caen

  collaborator OTHER

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• Centre Hospitalier du Pays d'Aix

  collaborator OTHER

• Hôpital de la Timone (MARSEILLE)

  collaborator UNKNOWN

• University Hospital, Rouen

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  collaborator OTHER

• Centre Hospitalier Universitaire de Saint Etienne

  collaborator OTHER

• Fondation Rothschild Paris

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Denis PEZET · University Hospital, Clermont-Ferrand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2014-12-31

Completion

2015-03-31

Countries

• France

Study Locations