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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01765257

Enrollment

Registered

2013-01-10

Start date

2013-06-30

Completion date

2015-03-31

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apathy, Drug-naïve Patients With Parkinson's Disease

Keywords

Drug-naïve patients with Parkinson's disease, Apathy, Rasagiline

Brief 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.

Detailed 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

Interventions

DRUGAZILECT®

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Lille Apathy Rating Scale (LARS) score	at the visit 3 (after 3 months of treatment)

Secondary

Measure	Time frame
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)
Motor assessment : Unified Parkinson's Disease Rating Scale	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)
Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery	at the visit 3 (after 3 months of treatment)

Countries

France

Contacts

Primary ContactPatrick LACARIN

placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026