Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Beijing Tiantan Hospital; Fujian Medical University Union Hospital; Guizhou Medical University; Huashan Hospital; Jiangsu Province Nanjing Brain Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital of Soochow University; Sir Run Run Shaw Hospital; The Affiliated Hospital of Hangzhou Normal University; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Dalian Medical University; The First Affiliated Hospital of Guangzhou Medical University; West China Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Rasagiline

Criteria

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)