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

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre Hospitalier de la côte Basque; Centre Hospitalier du Pays d'Aix; Centre Hospitalier Universitaire de Nīmes; Centre Hospitalier Universitaire de Saint Etienne; Centre Hospitalier Universitaire, Amiens; CHU de Rennes (Rennes); CHU Purpan (Toulouse); Fondation Rothschild Paris; H. Lundbeck A/S; H. Lundbeck A/S, TEVA; Hôpital de la Timone (MARSEILLE); Hôpital Dupuytren; Hôpital Haut-Lévêque; Poitiers University Hospital; University Hospital, Caen; University Hospital, Lille; University Hospital, Rouen
• Treatments: Rasagiline

Criteria

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