Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Second Affiliated Hospital, School of Medicine, Zhejiang University

Overview

To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

REM Sleep Behavior Disorder Parkinson Disease Synucleinopathies

Interventions

RasagilineDRUG

1 mg rasagiline

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline) * no clinical diagnosis of Parkinson's disease or dementia at baseline * age 30-75 * no concomitant or previous use of any other anti-parkinson medications * provide written informed consent Exclusion Criteria: * diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic) * secondary RBD (eg., drug-induced, immune-mediated) * nervous system comorbidities (eg., stroke, epilepsy, encephalitis) * severe psychiatric comorbidities * allergic to rasagiline * severe systemic diseases (eg., end-stage kidney disease, liver failure)

Outcomes

Primary Outcomes

Disease-free survival time

Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)

Time frame: 3 years after starting rasagiline treatment