Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Zhejiang University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Synucleinopathies; REM Sleep Behavior Disorder; Parkinson Disease

Treatments: Drug: Rasagiline

Study type: Interventional

Funder types: Other

Identifiers

NCT05611372

SAHZJU_RBD

Details and patient eligibility

About

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

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Early Intervention

Experimental group

Description:

0-52 week: rasagiline 1 mg/day

Treatment:

Drug: Rasagiline

Delayed Intervention

Active Comparator group

Description:

0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day

Treatment:

Drug: Rasagiline