Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Phase 2

Withdrawn

• Conditions: Synucleinopathies; REM Sleep Behavior Disorder; Parkinson Disease
• Interventions: Drug: Rasagiline

• Registration Number: NCT05611372
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-10
• Study Start: 2023-01-01
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 732

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Intervention	Rasagiline	0-52 week: rasagiline 1 mg/day
Delayed Intervention	Rasagiline	0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day

Primary Outcome Measures

Name	Time	Method
Disease-free survival time	3 years after starting rasagiline treatment	Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)

Secondary Outcome Measures

Name	Time	Method
Striatal dopaminergic innervation	0-3 years after starting rasagiline treatment	Striatal binding ratio from DAT-Scan
HAMA	0-3 years after starting rasagiline treatment
HAMD	0-3 years after starting rasagiline treatment
PSQI	0-3 years after starting rasagiline treatment
MoCA	0-3 years after starting rasagiline treatment
MMSE	0-3 years after starting rasagiline treatment
MDS-UPDRS-III	0-3 years after starting rasagiline treatment
RBDQ-HK	0-3 years after starting rasagiline treatment
PDQ39	0-3 years after starting rasagiline treatment
SCOPA-AUT	0-3 years after starting rasagiline treatment